16.12.2009   

EN

Official Journal of the European Union

C 306/1

1.1

For intercontinental air passenger traffic, the relation between the EU and North America is by far the most important. More than 60 million passengers and over 3.1 million tons of freight were carried in 2007. This makes it by far the most significant air traffic flow between the world regions.

1.2

EU — Canada and EU — US have entered into negotiations on creation of Open Aviation Areas (AOO). The Open Aviation Area concept extends full freedom of the air to both parties.

1.3

On 30 April 2007, the Commission signed the text of a comprehensive first stage Air Transport Agreement (first stage agreement) with the United States of America.

1.3.1

Even though the first stage agreement was a tremendous success it did not accomplish its prime objective — the creation of an OAA.

1.4

On 30 March, 2009, the Transport Council adopted a political position approving the signature of the EU — Canada Agreement. On 6 May 2009 at the EU-Canada summit in Prague the final text of this agreement has been marked.

1.4.1

The EU — Canada Agreement is the first agreement of the EU which achieves a complete opening of the markets, for traffic rights and investment, and, at the same time, reaching an unprecedented level of regulatory convergence and cooperation between the authorities.

1.4.2

EESC welcomes the EU — Canada Air Transport Agreement as the first fully following new development of the EU external policy in line with the Council conclusions of 2005.

1.4.3

EESC strongly supports an effort of the Commission to achieve similar results with the EU — US second stage negotiations.

1.5

EU — US second stage negotiations, which started in 2008, shall by virtue of Article 21 of the first stage agreement include the following items of priority interest to one or both parties: further liberalisation of traffic rights, additional foreign investment opportunities, effect of environmental measures and infrastructure constraints on the exercise of traffic rights, further access to the Government-financed air transportation, and provision of aircraft with crew. There is an expectation from the European stakeholders, that second stage negotiations should enhance further regulatory convergence.

1.5.1

The EESC wishes to remind that time is of the essence and empowered representatives from the EU and US side should restart the negotiations as soon as practically possible. If no substantial progress is made by November 2010, the EU can decide to suspend certain rights granted to US airlines.

1.5.2

Labour issues should receive a special attention as important part of the second stage negotiations. Support of the employees is very important. EESC encourages the second Labour Forum, which will be held in Brussels in June 2009, to produce tangible results in a form of recommendations concerning important social issues.

1.5.3

Implementation of an Open Aviation Area will increase traffic between EU and US what may cause some negative consequences to the environment. EESC recommends to the Commission to undertake strategic environmental impact analysis of the potential agreement.

1.6

The EESC priorities for the second stage agreement — it should deliver the essential ingredients of an OAA:

1.7

The EESC strongly encourages TEC to support second stage negotiations by giving them high political priority and enabling consultations through Transatlantic Labour Dialog (TALD) and Transatlantic Environmental Dialog (TAED) as well as other dialogues officially affiliated with TEC.

1.8

The UE — Canada Aviation Agreement should be the reference for the second stage EU — US Agreement. Change is possible — that is the main message from EU — Canada negotiations.

2.1

According to EUROSTAT data for intercontinental air passenger traffic, the relation between the EU and North America is by far the most important. More than 60 million passengers were carried in 2007 (5,6 % growth in relation to 2006; 22,3 % of extra EU-27 traffic).

2.2

According to IATA on the North Atlantic route between North America and Europe (including Russia), passenger traffic increased in 2007 by 7,6 % to 57,3 million passengers (in relation to 2006). This makes it by far the most significant air traffic flow between the world regions.

2.3

In 2007 between North America and Europe over 3.1 million tons of freight was carried, which made it one of the three main global transport routes.

2.4

The reasons for the scale of the EU — US aviation market are: geographical, cultural, as well as economic. In 2007 EU and US alone counted for 40 % of the global trade and 60 % of the global FDI. No doubt that aviation has contributed to the development of this largest trade and investment relationship in the world. The relationship between EU and Canada is also very strong (EU being the second largest direct investor in Canada).

2.5

Broad economic relationship between EU and North America is supported by closer regulatory cooperation. Transatlantic Economic Council (TEC) established in 2007 provides high-level forum for EU — US discussions on strategic economic matters with the aim for more regulatory convergence and enhancement of trade and investment. Preliminary talks on the possibility of a comprehensive EU — Canada trading agreement are currently under way.

2.6

This is in the context of such regulatory and economic cooperation, that EU — Canada and EU — US have entered into negotiations on creation of Open Aviation Areas (AOO). Study undertaken on behalf of the Commission (conducted before the current crisis) concluded that an EU — US Open Aviation Area would, over the first 5 years, stimulate more than 25 million additional EU — US passengers’ growth, generate more than EUR 15 billion benefits for consumers and create 80 000 new jobs in the EU and the US combined. It would be possible due to:

2.6.1

Implementation of an Open Aviation Area will increase traffic between EU and US what may cause some negative consequences to environment including: higher emissions, additional waste, increased noise. These and other environmental issues have been addressed in the past but not very successfully.

2.7

An Open Aviation Area concept extends full freedom of the air to both parties, removes restrictions on investment by foreign entities and permits wet leasing of aircraft under non-discriminatory, transparent conditions. It embodies a general commitment to regulatory convergence and to harmonisation of air transport standards in the field of safety, security and environment.

3.1

The Commission has initially started negotiating new EU — US aviation agreement on the basis of a mandate agreed at the Transport Council of 5 June 2003.

3.2

On 30 April 2007, the Commission signed the text of a comprehensive first stage Air Transport Agreement (first stage agreement) with the United States of America which is applied since 30 March 2008. This agreement replaced the existing bilateral agreements concluded by Member States.

3.3

The main elements of the EU — US air transport agreement are as follows:

3.4

First stage agreement was an important step towards an OAA. It established important principles for regulatory cooperation, and set up the Joint Committee to oversee its progress. It contributed to the removal of some barriers to market access.

3.5

Even though the first stage was a tremendous success it did not accomplish its prime objective — the creation of an OAA. In particular the first stage agreement is imbalanced in terms of market access granting US airlines unlimited 5th freedom rights within the EU, without EU airlines enjoying reciprocal rights within the US market (5th freedom rights grant airlines right to take traffic from their home country to the other Party and further to third countries). Selected market practices still favour US airlines, (i.e. the Fly America program). Finally it permits US investors to own a greater share of the voting stock of EU airlines (49 %) than EU investors can of US airlines (25 %).

3.6

Both sides agreed to carry on the second stage of negotiations beginning 60 days after first agreement coming into force.

4.1

After concluding the first-stage agreement with the US, Commission received a negotiating mandate from the Council in early October 2007 to launch negotiations on the EU — Canada Air Transport Agreement. After four rounds of negotiations, and following the instruction given by the 2008 EU — Canada summit in Quebec, the draft EU-Canada aviation agreement was initialled by the Commission on 30 November 2008. On 30 March 2009, the Transport Council adopted a political position approving the signature of the EU — Canada Agreement. On 6 May 2009 at the EU-Canada summit in Prague the final text of this agreement has been marked.

4.2

The main features of the draft agreement are as follows:

4.3

The EU — Canada Agreement is the first agreement of the EU which achieves a complete opening of the markets, for traffic rights and investment, and, at the same time, reaching an unprecedented level of regulatory convergence and cooperation between the authorities.

4.4

EESC welcomes the EU — Canada Air Transport Agreement as the first fully following new development of the EU external policy in line with the Council conclusions of 2005.

4.5

EESC strongly supports an effort of the Commission to achieve similar results with the EU — US second stage negotiations.

5.1

Second stage negotiations shall by virtue of Article 21 of the first stage agreement include the following items of priority interest to one or both parties:

5.2

As consultation process shows, there is an expectation from the European stakeholders, that the second stage should enhance further regulatory convergence.

5.3

It is possible that the parties might be able to achieve more progress in the second stage in the fields of cooperation initiated in the first stage such as:

6.1

Labour issues should receive a special attention as important part of the second stage negotiations. In particular, the promising ‘EU — US Aviation Forum on Liberalisation and Labor: past, present and future’ held in Washington DC in December 2008 should be further elaborated and its outcome taken into account as much as possible in areas such as: collective agreements, individual rights as regards contracts, working time, vocational training, social benefits and trade union representation.

6.2

EESC encourages the second Labour Forum, which will be held in Brussels in June 2009, to produce tangible results in a form of recommendations concerning important social issues related to future implementation of an OAA. Support of the employees is very important for the successful implementation of second stage negotiations.

6.3

Transatlantic Labour Dialog (TALD) should become involved in the second stage negotiations. The EESC in its opinion on ‘Transatlantic relations: How to improve the participation of civil society’ (1) expressed strong support for reestablishment of the TALD as a part of institutionalised dialogue between the EU and US. The EESC also recommended enlarging the advisory group to the TEC by adding TALD and Transatlantic Environmental Dialog (TAED).

7.1

As it was initially agreed by the parties of the first stage agreement there is a timetable for the second stage negotiations to be concluded:

7.2

If no substantial progress is made by November 2010, the EU can decide to suspend certain rights granted to US airlines. The EESC wishes to remind that time is of the essence and empowered representatives from the EU and US side should restart the negotiations as soon as practically possible.

8.1

The second stage agreement should deliver the essential ingredients of an OAA:

8.2

Second stage negotiations — because of its importance — should be given the highest attention by including into the agenda of TEC. The EESC strongly encourages TEC to support second stage negotiations by giving them high political priority and enabling consultations through TALD and other dialogues officially affiliated with TEC.

8.3

EESC recommends to the Commission to undertake (at the beginning of second stage negotiations) strategic environmental impact analysis. Strategic impact analysis identifying potential negative consequences to the environment would help to eliminate or minimize those negative effects throughout the EU — US negotiations.

8.4

The UE — Canada Aviation Agreement should be the reference for the second stage EU — US Agreement. Change is possible — that is the main message from EU — Canada negotiations.

8.5

Successful implementation of the EU — Canada agreement and successful completion of the EU — US second stage negotiations may have positive influence on further developments of EU-Latin America’s countries air transport agreements.

9.1

Because of the weight of the two respective markets, EU — US Agreement has the potential to lead to a new, post-Chicago, era in aviation.

9.2

By forming an ‘oasis’ of regulatory convergence and openness, also open to newcomers, the EU — US Agreement has the potential to substitute the 1944 Chicago Convention by spreading to other, like-minded, States, eventually encouraging more and more countries to revise their policies in order to benefit from the principles of this agreement.

16.12.2009   

EN

Official Journal of the European Union

C 306/7

1.1

The EESC supports the Community industrial property rights strategy proposed by the Commission. It reiterates a number of points already made in previous opinions.

1.2

It calls first and foremost on Member States to support the strategy, both as regards the future Community patent and the current international talks, particularly in the WIPO. The discussions on distribution of patent fees, which continue to hold up the adoption of the Community patent, are not appreciated by civil society, which is concerned with long-term progress and wants to see effective, practical conclusions which significantly reduce the cost of obtaining and maintaining patents.

1.3

The EESC stresses in particular the need to facilitate access to industrial property titles, for effective protection thereof and to combat — very often mafia-type — counterfeiting which is a burden on the economy and businesses and can expose consumers to serious risk (medicinal products, toys, household appliances etc.).

1.4

This requires a more effective dispute resolution system, circulation of final judgments handed down in a Member State (abolition of exequaturs), and better-organised, closer cooperation on police and customs matters.

1.5

More active involvement of organised civil society in international talks should help to strengthen European negotiators' positions and encourage technology transfer to the least-developed countries with a view to development of sustainable technology.

2.1

The Communication concerns the European strategy for industrial property rights, given their growing importance in value creation and innovation and their role in industrial development, in particular for SMEs.

2.2

While the majority of intangible industrial assets are covered by harmonised Community protection, the same does not apply to one key asset: patents. Although there is an EU-wide system based on the Munich Convention, under this system there is neither a unified judicial authority nor uniform case law among the national courts, which have jurisdiction in the area of patents. The cost of EU-wide patents is deemed to be too high, owing, in particular, to the cost of translation into national languages.

2.3

The London Agreement, which reduces translation costs, came into force on 1 May 2008, but language issues and the amounts to be paid to national industrial property offices continue to make it difficult to find a definitive solution.

2.4

The Commission feels that major progress has recently been made towards a Community patent paving the way for a coherent system protecting intangible industrial assets, as can be seen from the Recommendation from the Commission to the Council to authorise the Commission to open negotiations for the adoption of an Agreement creating a Unified Patent Litigation System (1).

2.5

In the Commission's view, ‘the intellectual property system should continue to act as a catalyst for innovation and contribute to the overall Lisbon strategy’. Lastly, the Communication sets forth measures which could be taken to achieve a European industrial property system of this kind, which would also make it possible to combat counterfeiting more effectively.

3.1

The Communication is one of a series of proposals, reflections and analyses which have been developed over the years since the failure of the Luxembourg Convention on a Community patent system in the early 1970s. The EESC, which has always supported the creation of the Community patent, welcomes the news that substantial progress has been made recently.

3.2

The language-related points cited by certain Member States in opposition to the Commission's proposals have never convinced the EESC. Indeed, it firmly believes that industrial property issues should be governed by private law. The question of official languages should be governed by the constitutional law of each country, which should not in principle be concerned with private agreements or disputes or hinder the application of property law on intangible industrial assets at Community level.

3.3

Over and above the legal and political debates, it is the interests of the European economy, businesses, inventors and holders of an indisputable property right which should prevail, so as to encourage the creation of value and jobs, especially in SMEs, which are in practice left quite defenceless against piracy and counterfeiting of their industrial property. The successive EESC opinions on patents, combating counterfeiting (2) and the Community patent (3) continue to apply and to reflect a considerable social demand for jobs and industrial development.

3.4

This Communication should be seen as supplementing Communication COM(2007) 165 final on Enhancing the patent system in Europe.

3.5.1

The EESC endorses the Commission's views on the growing importance of innovation as a driver of competitive advantage in the knowledge-based economy; knowledge transfer between public research, businesses and private R&D is essential for Europe's competitiveness. The Committee is very interested in the call to set up a European framework for knowledge transfer and supports in particular the proposal for harmonised definition and application of the research exemption to patent infringement.

3.5.2

This Community framework should make it easier to bring together fundamental research, R&D and the development of innovative applications, and to enforce the rights of each stakeholder more effectively with due regard for the autonomy of fundamental research, as it is often impossible to predict the practical applications of research programmes, which cannot, therefore, be guided solely by demand for industrial applications; moreover, research is a key pillar of the knowledge-based economy and the Lisbon Strategy.

3.5.3

Under this approach, Member States should continue to take the Better regulation programme as a basis and other stakeholders (inventors, universities, businesses and end-users) must be put in a position to make informed choices about the management of their industrial property rights

3.6.1

The EESC shares the view that the European industrial property system must encourage research, innovation and dissemination of knowledge and technology, which paves the way for new research and applications.

3.7.1

At the same time, access to industrial property must be facilitated with the Community patent, preventing patents from being used to hijack the protection system through ‘patent trolls’, who use poor quality patents (cross-references, overlaps, excessively complex — not to say incomprehensible — drafting of claims) in order to appropriate others' inventions; they thus obstruct the lodging of new patents or cause confusion which ultimately leads to breaches of competition rules, clogs up the courts and makes it difficult to find clear information and case law.

3.7.2

The Community patent should only be granted for genuine inventions which represent a real technological advance and are likely to be used in real industrial applications. Applications without a genuine, tangible inventive step must not be accepted, and the creation of genuine pools of patents which are complementary and can be used in a number of different applications should be encouraged. Claims should be strictly confined to the technical innovation made by the invention: their interpretation should be restricted in respect of use of the patent and disputes between patent owners.

3.7.3

The use of expertise and codes of good conduct to enhance the quality of patents lodged is essential, as it should be borne in mind that holders have exclusive rights for a relatively long period of time. This is the trade-off for publication, which, to encourage demand for licences from industry, allows knowledge to be disseminated but also exposes inventions to reproduction.

3.7.4

The EESC also feels that the quality of the patent is an essential guarantee for licence applicants and encouraging innovative applications. It therefore endorses the Commission's proposals in this area, such as the importance of the quality of the scientific and technical mechanism for examining patents and cooperation between national and European examiners, and the importance of recruiting qualified examiners, as they are the pillar of Community expertise in technology and applications. Examiners and other highly-competent experts make up the pool of human resources which is essential for the quality of the Community patent, and the Commission should give more consideration to this question so as to be able to give the best professionals the ethical and material conditions which are essential for high-quality examinations, to the benefit of applicants and industry.

3.7.5

Member States which grant patents without an examination, and therefore without a guarantee, should, as the Commission proposes, reflect on the quality of the patents they issue. The EESC believes in this connection that, in certain complex cases which are not clear-cut, these countries should call on the expertise of examiners or other national or even foreign experts to improve the quality of the national patents they issue.

3.7.6

Patent offices should also ensure strict respect for fields which are not patentable under the Munich Convention such as software and methods, algorithms and parts of the human body such as genes (4), which are unpatentable scientific discoveries.

3.7.7

Although the lifespan of the Community patent is 20 years in theory (TRIPS agreements), the actual average varies between five to six years for ICTs and 20 or 25 for medicinal products, giving an overall average of 10 to 12 years. Utility models have even shorter actual lifespans.

3.8.1

The EESC endorses the Commission's proposal to carry out an in-depth evaluation of the Community trade mark system, and also calls for cooperation to be developed between the European and national trade mark offices.

3.9.1

The EESC also endorses the proposed evaluation on obtaining plant varieties, not to be confused with GMOs. It welcomes the public consultation planned on the possibility of introducing protected geographical indications for typical non-agricultural products.

3.9.2

The EESC will carefully monitor arrangements for PDOs and PGIs and protected designations for agricultural products and spirits. It believes that protected designations could also be extended to typical products other than foodstuffs — craft products for example — and would also like other information increasing a product's value such as the fact that it is organic or sustainable to be displayed on designation labels as well, where appropriate, even if the qualities described are not necessarily a requirement for the designation to be granted.

3.9.3

As regards the aftermarket in spare car parts, which the Commission wants to liberalise, the EESC notes that there is some conflict between this liberalisation policy and protection of designs. Despite this, the EESC has adopted an opinion supporting this approach (5). However, it should be pointed out that the principle of exclusive rights is being breached and that car manufacturers are required to supply original spare parts for a mandatory length of time, while other manufacturers are not. Logically, the principle of a mandatory licence should apply, and it should be mandatory to use the same materials where parts contribute to the vehicle's structural solidity.

4.1

Like the Court of First Instance, the EESC feels that in more and more situations, owing to inflation of low-quality titles from certain countries, the best way to resolve certain conflicts between applicable rights is usually to apply the theory of abuse of rights. This should result in a genuine principle of mandatory licensing, which could lead to a rebuttable presumption of a requirement to issue a licence at a reasonable price under fair, non-discriminatory conditions. In all cases, foreign patents relating to fields excluded by Community law or which are very poor quality should not be recognised as valid, enforceable titles.

4.2

The Commission believes that standard-setting helps achieve a better industrial environment. For the EESC, standard-setting, which benefits consumers and SMEs, must be carried out in an open and transparent manner. The EESC endorses the view that the owner of an essential proprietary technology, which is then taken as a standard, extracts an over-inflated value for his title if they conceal their patent during the standard-setting process. A penalty system should apply in the event of this behaviour.

4.3

The future Community patent should require a higher level of quality, in line with the criteria set out by the Commission in respect of the European strategy, and also a specialised jurisdiction system, in particular to avoid ‘patent ambushing’ and other distortions of competition, which are very often based on poor-quality titles. Good patents are ousted by bad ones.

4.4

The EESC welcomes with interest the proposal for a study to analyse the interplay between industrial property rights and standards in the promotion of innovation; it will also take part in the planned consultation on standard-setting in ICTs, which will touch on this interplay.

4.5

In the current period of development of new, complex technology where manufacturing a product involves numerous discoveries and a large number of inventions and patents, a cooperation strategy is needed, maybe involving cross-licensing systems or patent pools. A balance should be ensured between stakeholders, to avoid potential distortion of competition and the rights of ‘small inventors’ being breached, in view of the huge patent portfolios of large businesses, some of which lodge thousands of new patents each year in the field of ICTs.

5.1

In a globalised market SMEs and VSEs (6) have great difficulty in protecting their trade marks and patents (where they have them) as many of them are involved in subcontracting. However, a large number of businesses are reluctant to lodge patents, often because of a lack of information or fear of a system which is known to be complex and costly. Sometimes the exclusive rights granted in certain countries are circumvented by counterfeiting in other countries where patent owners' rights are not protected.

5.2

Thus, manufacturers often rely on trade secrets, but these secrets are not always safe, thanks to chemical analysis of products and the development of industrial espionage. For example, in perfume manufacturing, there used to be no patents as that would have meant publishing the chemical formula of components. Today, current analysis techniques mean that trade secrets no longer provide protection, and proper legal protection should be established for complex products, perhaps a form of copyright.

5.3

Reluctance to lodge patents, even if only because of the lodging and renewal fees associated with the current European patent, has had the effect of holding back technology transfer as the investors concerned have been unable to obtain licences; this is a loss for the European economy. SMEs and VSEs should therefore be supported and encouraged to obtain industrial property rights and to use them in business strategies involving several businesses which own titles and operate in the same sphere of activity, with a view to implementing inventions combining several different discoveries. In any case, industrial property title owners are in a better position to interest investors or obtain credit for developing their activities.

5.4

As the EESC has often stressed, European industry needs affordable, high-quality patents which are valid throughout the Community and stimulate the internal market.

5.5

An inexpensive, rapid dispute-resolution system is also needed; mediation should be encouraged to resolve certain disputes. Arbitration is also an alternative. The judicial system for patents should, for its part, be specialised, easy to access and expeditious so as not to hold back economic progress.

5.6

These are questions of public interest, and it is hard to understand why they have remained on hold for so long; it is true that very large businesses are able to lodge patents under the current system, thereby generating large amounts of income for the European Patent Office and national member offices. The purpose of the system is not that, however: it is to encourage industrial innovation and development, benefiting businesses and generating new skilled jobs, although expenditure will be needed to ensure effectiveness and extension of titles issued to innovative businesses and individuals.

5.7

The EESC firmly believes that individuals working in a business who contribute directly to innovation and lodging of patents should be entitled to part of the income generated by their inventions (the issue of the employee inventor, or ‘work for hire’); this happens in some countries but the practice should be extended to give innovation a greater boost.

6.1

The EESC has already commented in detail in a number of opinions on enforcement of IPRs and combating piracy and counterfeiting, notably in one Opinion (7) to which the reader is referred in particular.

6.2

It is up to Member States which have issued intellectual property titles to enforce the exclusive rights they have granted, notwithstanding the general principle of exclusion of abuses of rights. Counterfeiting is a serious offence against the economic interests of innovative businesses, as well as the image of Community industry, and exposes consumers to serious risks. Moreover, it is difficult for SMEs to defend themselves on their own and they need tangible help.

6.3

High-quality legislation, jurisdiction systems and customs controls at the EU's borders are essential to combat counterfeiting.

6.4

The EESC therefore advocates strict compliance with the Brussels I Regulation and developing judicial and customs cooperation to this end. Final judgments handed down in a Member State should be accepted without an exequatur in all the other Member States.

6.5

Under Community law, the zero-tolerance approach advocated by the Commission to infringement of industrial property rights and copyright should target offenders who produce imitations or copies commercially, as the EESC has already stated in previous opinions. Industrial property rights cannot be protected by clamping down indiscriminately. Mafia-type counterfeiting rings and large producers should be targeted to put an end to an industry which is a burden on growth and jobs in the Member States.

6.6

Education and information also have a key role to play as regards consumers, who must be aware of what is involved in the production of imitations, including child labour or forms of forced labour. They must be warned of the risks entailed in buying certain items such as medicinal products on websites selling for the most part highly-dangerous imitations.

7.1

At international level, it is essential to implement a strategy to ensure respect for European IPRs both within and outside Europe in order to tackle counterfeiting and piracy. At the same time, Europe should endeavour to encourage sustainable-technology transfer to developing countries.

7.2

International agreements on trade marks, patents and copyright follow old rules on treaty law (Vienna Convention). The EESC condemns the regrettable lack of transparency. It is not just a question of involving the best experts in national delegations, but also of adopting a European approach, especially when it comes to the quality requirement for protected titles. Civil society and its organisations should be more involved in these talks so that the European Union's economic partners know that ‘European delegations’ have wide support based on prior consultation and involvement in following talks — which could drag on for years.

7.3

The requirements of sustainable development and international cooperation to achieve this should take precedence in the global economic area. All talks must aim to find solutions which meet the public's expectations and serve the interests of the organisations concerned.

8.1

The EESC supports the Commission's strategy, subject to some reservations and the suggestions made above.

8.2

It is fully aware of the obstacles and difficulties in the way of reforms, which will be problematic and costly, but it firmly believes that the sustainable growth generated by a European protection system will result in tax revenue.

8.3

The Community patent will boost investment in innovative technology.

8.4

In this area the EESC will continue to support all tangible Community initiatives seeking to improve applicable law, dispute resolution and protection of IP title owners in the fight against mafia-type organisations responsible for counterfeiting. It stresses once again the urgent need for solutions, which have been too long awaited by businesses and the public.

16.12.2009   

EN

Official Journal of the European Union

C 306/13

1.1

International science cooperation has a broad — and invariably favourable — impact both on scientific and technical progress among the stakeholders involved, and also on understanding between nations. This is true not only within the European Research Area (ERA), but also right across the world.

1.2

Hence the Committee welcomes the Commission communication and endorses its basic objectives. Similarly, it welcomes and supports the relevant decisions (1) of the Competition Council of 2 December 2008, including the tone to set up a high-level group of experts (dedicated configuration of CREST).

1.3

The Committee backs the Commission in its bid to achieve a coordinated approach by the Member States to securing international framework agreements, and to incorporate in an appropriate way the thematic targets of international cooperation into the joint research programming and the preparatory work for the 8th Research Framework Programme.

1.4

At issue here are basic questions such as researcher mobility and intellectual property agreements, as well as moves to foster personal initiative and promote conferences as a conduit for knowledge-sharing and communication, and the need to boost the attractiveness of the ERA.

1.5

The Committee feels that, even with due regard for subsidiarity, the Commission has a key role to play in international agreements on major scientific and technical infrastructure projects, since the costs these entail (for building and operation) and the effort involved in using them are, generally speaking, beyond the wherewithal of individual Member States and are thus a typical task for the Community. The Committee therefore also endorses the objective of pursuing international research infrastructure projects (as has already been done with the ITER) or of involving international partners in European research infrastructure projects.

1.6

The Committee supports the Commission proposal to highlight ICT (information and communication technologies) as an issue for international cooperation, and at the same time recommends that the new category of ICT for Science and Research be introduced. However, the Committee would recommend that similar importance should also be attached to other key global questions such as energy, climate, the environment and health, though this should not mean ruling out other issues, particularly fundamental research, from international cooperation.

1.7

The Committee stresses that the success of international cooperation is very much dependent on the attractiveness of the European Research Area and on the performance of European universities and research institutes. The measures needed to achieve this are key elements of the Lisbon strategy. It is therefore all the more important, in the light of the current economic and financial crisis, to implement an anti-cyclical policy and to use all available financial and structural means to support the European Research Area and the foundations on which it is built, including its international dimension, and to make it attractive.

2.1

The communication presents a strategic European framework for international cooperation in science and technology (S&T). Its purpose is to:

2.2

The Commission communication responds to the Council conclusions of February 2008, and is one of the five Commission initiatives on the future of the European Research Area (ERA). The proposed framework is designed to contribute to the free circulation of knowledge — ‘the EU's fifth freedom’ — at global level, to raising the S&T profile of Europe worldwide and to disseminating European ICT (Information and Communications Technology) know-how in the world.

2.3

Mobility of researchers is an essential feature here.

2.4

Cooperation with scientifically advanced partners will differ in nature from that with countries which are developing their science base; but both types of cooperation are needed.

2.5

Policy dialogues on S&T are to be launched with countries which signal an interest in becoming associated to the 7th framework programme for research and technological development (FP7).

2.6

By far the biggest share of publicly funded R&D investment comes from the Member States. Thus, the EU can effectively contribute to international cooperation across the world only by strengthening the partnership between the Member States and the European Community.

3.1

Preliminary remarks. In its 2000 opinion (2) on the Communication from the Commission Towards a European research area, the Committee noted as a key hallmark of scientific research that ‘its methods and the related scientific terminology are the same in all countries and languages’, continuing: ‘Thus there is a single scientific “global culture” and a single scientific “technical language”, and associated common values. (…) Only this allows a global international exchange of knowledge and worldwide cooperation.’

3.2

Point of departure. It is encouraging to note that, for many decades now, a wide range of international (i.e. extra-EU) scientific and technical cooperation projects have been in place in many Member States — both between companies (global players) and between publicly supported research-performing organisations and their research groups. The various science and technology associations (3) also give a key fillip in this area, as do specific international organisations including the International Energy Agency (IEA) (4), the World Health Organisation (WHO), the International Union of Pure and Applied Physics (IUPAP), the International Panel on Climate Change (IPCC) and also, among others, the European Space Agency (ESA) and the European Organisation for Nuclear Research (CERN). Overall experience to date has shown that those countries that openly exchange and cooperate in this area also reap cultural and economic benefits in the medium and long term.

3.3

Basic endorsement. The Committee thus endorses the basic objectives of the communication. Cooperation between countries across the world saves resources and disseminates new knowledge faster. Generally speaking, it has a broad — and invariably favourable — impact both on scientific and technical progress and also on understanding between nations. In this way, it also in particular helps build up good relations with the EU's neighbours. However, cooperation must not become an end in itself, as it requires additional expense that must in each case by justified by the expected added value.

3.4

Tension between competition and cooperation. The issue of international R&D cooperation under discussion here also touches on the tension between competition and cooperation (5). In basic research, competition is, in the main, considered only in terms of setting priorities for scientific findings and garnering the associated prestige. Competition issues take on growing economic importance, however, as R&D starts to produce marketable processes and products that bring economic benefits in their wake.

3.5

Promotion and recognition of personal initiative and mobility: The most important initiators and players in international cooperation are researchers themselves (scientists and engineers). It is thus vital to promote and recognise the importance of personal initiative and mobility. To that end, individual support is required, as is encouragement for mobility through measures similar to those in place — or still being aimed at — within the European Research Area.

3.6

Promotion of international conferences and science and technology associations. Specialist conferences are the main forum for publicising and evaluating findings, pooling knowledge and ideas, launching cooperation initiatives and developing new or improved concepts. Such conferences are generally organised by science and technology associations, which are typical civil society organisations. The Committee therefore recommends that there should be greater awareness and recognition of their value and that their efforts to disseminate knowledge, evaluate findings and coordinate research should be drawn on and encouraged (6).

3.7

Promotion and recognition of self-organisation: In addition to individual researchers, research institutes and universities are the prime movers in initiating and cultivating international cooperation — and in establishing the requisite contractual arrangements — with selected partner bodies, often on a number of different fronts within their own specific spheres of competence. That should be encouraged and supported, not least by putting in place reliable legal, financial and staffing parameters that also offer a sufficient degree of continuity.

3.8

Additional support: In order to facilitate or initiate the action outlined above, government-level framework agreements between Member States and non-European third countries are helpful, if not essential. The Committee feels that this is the key coordinating task, i.e. to ensure that there is policy coherence in international R&D cooperation (research policy, but also neighbourhood policy, development policy, industrial and economic policy) — using both European and national instruments — towards third countries.

3.9

Role of the European Commission: While, on the one hand, the Committee would stress that research bodies and businesses must act under their own responsibility to initiate and flesh out those aspects of international cooperation — and the attendant programmes — that may be useful to them, it does on the other hand feel that the Community and the Member States have important tasks to perform on basic, overarching questions such as the following, which should be discussed in a spirit of partnership between the European Commission and the Member States:

3.10

Key message of the Commission communication: Accordingly, the Committee feels that the Commission communication's key message is to bring the ever-growing importance of international cooperation to the attention of the Council and the Parliament, to put in place a coordinated approach by the Member States and the Community to securing international framework agreements, and to explore the thematic and regional targets of international cooperation and take appropriate account of these in the joint research programming and the preparatory work for the 8th RTD Framework Programme.

3.11

European Research Infrastructure. The Committee feels that, even with due regard for subsidiarity, the Commission should play a stronger, direct role in international cooperation on large apparatus and other projects that fall under the heading of European research infrastructure, since the costs these entail (for building and operation) and the effort involved in using them are, generally speaking, beyond the wherewithal of individual Member States. This applies in particular to those programmes supported and coordinated by the Commission in which the EU is a direct partner (e.g. the ITER fusion programme) or plays a key coordinating role, for instance the European Strategy Forum on Research Infrastructures (9) (ESFRI) and the additional measures taken under it. The Committee is thus particularly supportive of the Commission's objective of ‘tackling scientific challenges through global research infrastructures’. This may also involve the participation of international partners in European research infrastructure projects. The geographical aspect and the available scientific potential should also be taken into consideration in this context.

3.12

Strategic Forum for International S&T Cooperation — Crest Group: The Committee welcomes and supports the setting up of a Strategic Forum (dedicated configuration of CREST) in accordance with the preliminary recommendation of the Competitiveness Council of 14 November 2008 and its corresponding decision of 2 December 2008. (10) It also welcomes and supports the corresponding aims, i.e.:

3.13

International dimension of the European Research Area: The Committee wishes to place special emphasis on the international dimension of the European Research Area. This involves both greater cooperation between the Member States (11) on the basis of ‘variable geometry’ (12) and the coordination of R&D activities at international level.

3.14

Convergence of humanities and natural sciences: The Committee recommends that international cooperation be expanded beyond the area of science and technology into areas where these have discernable links to the humanities and the related ethical issues.

3.15

Shortcomings in the communication: The Committee regrets, however, that the communication does not draw sufficient attention to the many existing instances of cooperation and to the agreements in place (see point 3.2) or to the initiators or tools involved, thus giving the uninformed reader an overly negative picture of the current situation. Moreover, past experience gained in this way should be the basis for any further moves forward. Better use should also be made of initiatives such as those of the specialised associations.

4.1.1

ICT including ‘ICT for science and research’: Among the areas of key importance for international cooperation, the Commission draws particular attention to ICT as a key cross-cutting technology for science and industry, including the goal of disseminating European ICT know-how in the world. The Committee fully supports this, but would nonetheless point out that, as an issue, ICT must not be interpreted too narrowly, but should encompass the entire area of activity — from the harmonisation of differing standards to communication networks and high-performance computers and their increasingly sophisticated software. The wide-ranging discipline of scientific computing (13) has now developed into a very significant additional pillar of scientific and technological method. This might be achieved best by introducing a sub-category ‘ICT for science and research’. The Committee also notes the significant potential benefits of cooperation with groups of experts in international partner countries.

4.1.2

Energy, climate, environment and health. However, there are other equally important global issues — including the energy and climate question and research in the fields of environment and health — that should also have an appropriate profile in the proposed strategy.

4.1.3

Remaining open to other issues: It is true that, at certain times, particular questions and issues do take on special importance and urgency — as is currently the case for energy and climate questions, for instance — and that there is also a need to pool scare resources. However, given the unpredictable nature of new findings, and of the timeframes involved in transforming those findings into technical applications, the Committee recommends that the range of issues to be addressed in international framework agreements should not be limited from the outset but should remain open to other thorny questions that may arise and take on new currency in the future. International cooperation is, moreover, also a particularly important element of pure research.

4.1.4

Pure research (or basic research): The Committee recalls the contribution of pure research to the discovery of the laws of nature on the basis of which almost all modern technologies were developed and medical discoveries were made. The Committee recommends that the advice of the European Research Council (ERC) be sought regarding implementation.

4.2

European self-interest and differing categories: It is in Europe's own interest to make a clearer distinction between different categories of international cooperation, i.e.:

4.3

The language question — a problem, but not a taboo. The international language of science is English. Thus those EU countries where English is the native language or is mastered by most R&D stakeholders have a natural advantage in terms of attracting students — as future decision-makers in scientific cooperation — and of engaging in scientific exchanges. The other Member States should also seek appropriate solutions that are of benefit both to themselves and to the European Research Area.

4.4

Mobility and avoiding brain drain. The mobility of scientists, i.e. researchers, teaching staff and students, is vital to knowledge-sharing and cooperation and is, nowadays, also a virtual prerequisite for anyone wishing to take a research career further. However, in the long run, mobility can also mean that a country's best talents move to wherever they find the best and most attractive research environment and opportunities for their own personal development. This is a problem both for the EU as a whole — in relation to its neighbours and to the USA for instance — but also between individual EU Member States.

4.5

Providing opportunities. Since it is simply not an option to prevent mobility and thus deprive talented young people of opportunities for development, it is vital for the EU that all the Member States — and indeed the Community itself — should, as part of their research policy, work to develop centres of excellence and/or other attractive models, and thus to strike an appropriate overall balance in the desired mobility flow (brain circulation). Resources from the Structural Funds should be used for this purpose.

4.6

Making Europe more attractive — the European Research Area: The same is also true of the relationship between the EU as a whole and its international partners. A crucial factor in the success of international cooperation and in the EU's negotiating position on the various agreements is the attractiveness of EU research and development, including training facilities/university infrastructure, and the individual career opportunities of its researchers. Strengthening the European Research Area is thus one of the most effective means of avoiding a brain drain out of the EU, attracting the world's best scientists to Europe and being able to negotiate international agreements from a position of strength.

4.7

Lisbon strategy, current crisis and anti-cyclical policy: The success of international cooperation is thus very much dependent on the attractiveness of the European Research Area and from the performance of European universities and research institutes. The measures needed to achieve this are key elements of the Lisbon strategy. It is therefore all the more important, in the light of the current economic and financial crisis, to implement an anti-cyclical policy and to use all available financial and structural means to support the European Research Area and its foundations, including its international dimension, and to make it attractive. At the same time, the Committee calls on the Commission and the Member States to adopt an anti-cyclical staffing policy in order to counteract the threat of unemployment for young graduates that may arise from a reduction in R&D activities in the private sector. (15)

16.12.2009   

EN

Official Journal of the European Union

C 306/18

1.1

The Committee takes note of the plan to improve information to the public on prescription-only medicines and wishes to express its reservations about individual points in the proposal for a directive. A harmonised legal framework would help to ensure legal certainty and clarity within the Community. The EESC has doubts about the proposal for a Directive COM(2008) 663 final, which would authorise the pharmaceutical industry to communicate directly with patients.

1.2

With the same aim in mind, the EESC considers that the significant variations from one Member State to another in rules on the legal status of medicines with regard to prescription and dispensing are an obstacle to good, understandable information on medicines. Accordingly, the EESC calls on the Commission to continue working towards harmonisation of the setting of rules on the prescription and dispensing of medicines.

1.3

Every citizen (patient) has the right to comprehensive and comprehensible information in their own language. This also applies to online information about prescription-only medicines. This information should relate to the illness in question, i.e. the information on the medicine concerned should also give patients an explanation of the illness it may be used to treat (1). In view of demographic changes, it is particularly important to provide older patients with the means of accessing information (2).

1.4

The EESC recommends setting up an independent body to provide information alongside market authorisation holders. Such a body would be able to provide information on medicines from different manufacturers used in a particular indication. The EESC therefore urges that the proposal for a directive be amended accordingly to advocate such independent bodies.

1.5

Under Article 100h(1) of the proposed directive, websites have to be registered in advance with the national competent authorities. This would ensure that public concerns, including in relation to online material, can be more easily and effectively met.

1.6

It is difficult to distinguish between advertising and information in a given case, as the dividing line between these two areas is often blurred. The EESC considers that the directive should define authorised information on the basis of quality criteria on independent, comparative and comprehensible information, without waiting for the Commission to draw up ‘guidelines’.

1.7

The EESC urges that information on non-interventional scientific studies not be considered as information which can be disseminated to the public, and that the relevant sections of the proposal be deleted.

1.8

‘Health-related publications’ are not an appropriate means of disseminating information on prescription-only medicines. This could constitute ‘push’ information, whereas the scope of the directive should be confined to information which patients are actively looking for. The option of disseminating information by means of ‘health-related publications’ should therefore be deleted from the proposal for a Directive. Conversely, websites can be an appropriate information channel, but the new Article 100c (b) must specify that it is referring to websites exclusively devoted to medicines and approved by the European agency and the national agencies.

1.9

The proposal for a Directive also reflects the need to make officially approved information more readable, especially in the package leaflet. The EESC strongly supports such efforts, also outside the context of proposal under discussion. Patients must be given full and comprehensible information, especially concerning the side-effects of medicines and patient lifestyle factors. Doctors and healthcare professionals should also be given further training in this regard.

1.10

The EESC calls on the Member States to set up an industry-independent online portal, soon after the entry into force of the Directive, which can be used to disseminate information on prescription-only medicines. For this to happen, conferences and forums must be organised in the Member States in cooperation with patient organisations and social security bodies including complementary sickness insurance bodies.

1.11

The directorates-general are advised to inform patients of the possibilities and dangers of online options for finding information on medicines.

1.12

The EESC endorses the methods for monitoring information set out in Article 100g. Wherever prior checks on information appear necessary, they should be carried out. However, if the content of the publication has already been approved by the competent authorities or if there is a different mechanism in place to ensure equally adequate and effective monitoring, no prior checks are needed. Member States must have scope to decide whether a mechanism is in place in their territories to ensure equally adequate and effective monitoring. Article 100g thus regulates the issue in a balanced way.

1.13

Communication between patients and healthcare professionals — in particular doctors and pharmacists — must remain the top priority. Personalised advice from healthcare professionals is vital to ensuring that prescription-only medicines are used safely.

2.1

The proposal for a Directive is intended to create a clear framework for provision of information by marketing authorisation holders about their prescription-only medicines to the general public with a view to enhancing the rational use of these medicines.

2.2

The aim is to ensure the high quality of information provided by coherent application of clearly defined standards across the Community.

2.3

The Directive is to allow the provision of information through channels that address the needs and capabilities of different types of patients.

2.4

Marketing authorisation holders are to be allowed to provide in an understandable way objective and non-promotional information about the benefits and the risks of their medicines.

2.5

The directive is also intended to make sure that monitoring and enforcement measures are in place to ensure that information providers comply with the quality criteria, while avoiding unnecessary bureaucracy.

3.1

Directive 2001/83/EC on the Community code relating to medicinal products for human use (3) provides for a harmonised framework for the advertising of medicines at Community level. This legislation prohibits the advertising to the general public of medicines subject to prescription. However, the Directive does not include detailed provisions on information on medicinal products, and only provides that certain information supply activities are exempted from the advertising provisions.

3.2

On the basis of Article 88a of Directive 2001/83/EC (4), a Communication from the Commission to the European Parliament and the Council concerning the Report on current practices with regard to the provision of information to patients on medicinal products was adopted and submitted to the European Parliament and the Council on 20 December 2007 (5). The report notes that rules and practices on what information can be available vary significantly among Member States. While certain Member States apply very restrictive rules, others allow for several types of non-promotional information to be made available.

4.1

The proposal for a Directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use envisages exempting certain types of information from the scope of the provisions on the advertising of medicines (Title VIII) and regulating information on prescription-only medicines in a new Title (VIIIa).

4.2

The types of information on authorised medicinal products subject to medical prescription which marketing authorisation holders may disseminate to the general public or members thereof are listed in Article 100b of the proposal for a Directive. These include the summary of product characteristics, labelling, and package leaflet of the medicinal product, as approved by the competent authorities. Medicinal product-related information on non-interventional scientific studies is also to be allowed.

4.3

Information may only be disseminated through health-related publications, internet websites on medicinal products, and written answers to requests for information of a member of the general public (Article 100c).

4.4

Article 100d sets out general quality standards for information and required content.

4.5

Article 100g sets out provisions for the monitoring of information. The methods used should be based on the control of information prior to its dissemination, unless the content of the information has already been approved by the competent authorities or an equivalent level of adequate and effective monitoring is ensured through a different mechanism.

4.6

Websites with information on prescription-only medicines are to be registered and may not contain web-TV.

5.1

The aim of improving information to the public on prescription-only medicines gives rise to numerous reservations in that it authorises the pharmaceutical industry to communicate directly with patients.

5.2

As well as rules on information provided to the general public, accompanying measures are needed, particularly in terms of ensuring that information is accessible and comprehensible. It is especially important to take account of demographic change, by also informing older people and other groups with particular information needs about possibilities for using the Internet in a way which is comprehensible to them.

5.3

However, after the directive is transposed, the problem also arises of differences between the status of particular medicines in the Member States. As a result, advertising of a medicine may be permitted in one Member State, while another Member State only allows information to be provided in accordance with the provisions of the Directive. Differences in the type and quality of information available in individual Member States will therefore remain.

5.4

The proposal for a Directive also responds to heightened EU public interest in information on existing medicines and treatment options. Patients have become responsible consumers of healthcare, increasingly seeking information about medicines and treatments. However, the image of the ‘empowered consumer’ is an idealised picture.

5.5

More and more people are searching online for information about medicines, including those which are available only on prescription. The growing importance of the Internet must be taken into account by approaching it as a key source of information which the public can use to find out about medicines. In this context, it should be noted that action is also needed to enable those social groups that have hitherto been less frequent users of the Internet to make better use of the possibilities this medium affords (see point 5.2).

5.6

Another reason that a framework had to be established in Community law for the provision of information on prescription-only medicines is the dubious quality of some of the information available online. We must ensure that high-quality information is made available. Article 100h)(5) of the proposal requires registered websites to be clearly identified so that the public can distinguish them from suspect ones.

5.7

Since the information which market authorisation holders are allowed to disseminate on prescription-only medicines is to include the package leaflet, the EESC supports ongoing efforts — outside the context of the proposal under discussion here — to improve the readability of such leaflets. This can only happen if patient organisations are involved. The EESC recommends that a working group be set up to look into this issue.

5.8

The EESC recommends setting up an independent body to provide information alongside market authorisation holders. Such bodies could provide information on medicines from different market authorisation holders and, for instance, also present different medicines (especially generic medicines) available for a particular indication.

6.1

The EESC welcomes the continued ban on advertising prescription-only medicines to the public.

6.2

The proposal for a Directive is rightly based on the principle that officially approved information such as the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities should be classified not as advertising but as information. It should be permissible to make such information available to the general public.

6.3

If the presentation of the criteria set out in point 6.2 above differs from the officially approved form, compliance with the quality criteria set out in Article 100d must be ensured. Article 100b(b) should explicitly refer to the requirements of Article 100d, to ensure clarity. Presentation of officially approved information in a different form may be necessary due to the fact that at present officially approved information such as package leaflets and specialised information may sometimes be difficult for patients to understand. The EESC therefore reiterates that such information in the officially approved form must be made easier to read and more readily comprehensible (see point 5.7).

6.4

Information on non-interventional scientific studies should not be disseminated to the public. There are considerable doubts as to whether patients are capable of correctly evaluating information on non-interventional scientific studies and drawing the conclusions that are relevant for them, irrespective of the quality of such information. Information about such studies should continue to be provided by healthcare professionals on a case-by-case basis

6.5

‘Health-related publications’ are not an appropriate means of disseminating information on prescription-only medicines. Given that the term itself can be understood in different ways, it is doubtful whether it would be interpreted uniformly in the individual Member States. It may also be asked whether this method of disseminating information crosses the boundary between information sought by patients (‘pull’ information) to information actively disseminated to patients (‘push’ information), given that patients who buy health-related publications are not necessarily looking specifically for information on a particular medicine (6).

6.6

Under Article 100h(1) of the proposed directive, websites have to be registered in advance with the national competent authorities. This would ensure that public concerns, including in relation to online material, can be more easily and effectively met.

6.7

The costs of registration should not place an unreasonable administrative burden on either authorities or the industry.

6.8

It makes sense for information to include a statement indicating that a health professional should be contacted if the patient requires more detailed explanation of the information provided. While providing information on prescription-only medicines may meet patients’ heightened need for information and reflect the changing profile of the ‘informed’ consumer, the information to be disseminated under the proposed directive cannot take the place of explanations provided by health professionals to individual patients.

6.9

The EESC endorses the methods for monitoring information set out in Article 100g. Wherever prior checks on information appear necessary, they should be carried out. If the content of the publication has already been approved by the competent authorities or if there is a different mechanism in place to ensure equally adequate and effective monitoring, no prior checks are needed. Member States must have scope to decide whether a mechanism is in place in their territories to ensure equally adequate and effective monitoring. Article 100g thus regulates the issue in a balanced way.

6.10

The EESC is wholeheartedly in favour of drawing up guidelines on information permitted under Title VIIIa, as provided for in Article 100g(2) of the proposed directive. These guidelines and the code of practice set out therein could clarify the distinction between unauthorised advertising and authorised information. This is necessary given the impossibility of a drawing an abstract distinction in a general definition.

6.11

The EESC endorses the ban on having web-TV on websites and on disseminating information by TV or radio.

16.12.2009   

EN

Official Journal of the European Union

C 306/22

1.1

The EESC endorses the Commission's intention to establish a stronger pharmacovigilance system through increased market surveillance by reinforcing monitoring procedures providing for clear roles and responsibilities for the key responsible parties and for a transparent EU decision-making.

1.2

The EESC strongly recommends that the new regulatory framework put the patient at the centre of the EU legislation, providing for sufficient harmonised rules in this area in order to assure to EU citizens, at least on the long run, an equal access to sound information across the EU, and the full availability of safe, innovative and accessible medicines registered in any part of the EEA market at reasonable price.

1.3

Along this line, the EESC is in favour of significant improvements in the present situation, given that the differences emerged between the national legislative, regulatory and administrative provisions on medicinal products have deep repercussions on patients and that these differences could hinder intra-EEA trade and affecting the good functioning of the internal market.

1.4

The Committee, therefore, underlines the importance of involving patients in pharmacovigilance including direct patient interactive reporting of suspected adverse reactions: the responsibility for health care should become increasingly shared with patients taking a more active interest in their own health and care options and in a two-way channel of communication, including a sound use of internet.

1.5

The Committee support clarification and codification of tasks and responsibilities across and between all stakeholders: Member State Competent Authorities, EMEA (including its committees), Commission and Marketing Authorisation Holders, including their Qualified Person for Pharmacovigilance, and patients. The EESC believes that the new elements introduced by the proposals must neither call into question, nor weaken existing structures and procedures at local level, especially those that involve the patient and health professionals, provided that common parameters for comparable data are assured in transparent and rapid procedure.

1.6

The Committee endorses the establishment of a new Pharmacovigilance Committee to replace the existing Pharmacovigilance Working Party within the EMEA and believes that the setting up of such a committee could result in better and faster functioning of the EU system, provided that tasks, procedures and relations with the other existing committees are better clarified.

1.7

The collection and management of pharmacovigilance data in the EudraVigilance database must be fostered with new human and financial resources to become the single interactive point of rapid receipt and fast delivery of pharmacovigilance information for medicinal products together with an effective data management. It is vital for public confidence that there should be a transparent and user-friendly access policy open to all the stakeholders, especially the patients, in an interactive way, respecting data protection and confidentiality.

1.8

The EESC underlines the importance of simplified procedures for small and medium-sized enterprises (SMEs) and asks for the optimisation of the ‘SME office’, providing financial and administrative assistance to micro, small and medium-sized enterprises.

1.9

As international markets expand and companies operate more and more on an international basis, the EESC recommends to foster the coordination of Member States’ and EC actions both at European and international level.

1.10

The EESC requests that within 5 years, the EMEA presents to the EP, the Council and the Committee, an independent external evaluation of its achievements on the basis of its new Regulation and the work programmes together with an evaluation assessment of the working practices and the impact of the new mechanism provided by this proposal, as well of the interactive functioning of the Eudravigilance database.

2.1

Harmonised Community rules on the pharmacovigilance of medicinal products for human use are provided by Regulation EC/726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMEA), as regards medicinal products authorised by the Commission in accordance with the centralised authorisation procedure of that Regulation, and by the Directive 2001/83/EC.

2.2

Risk assessment during product development should be conducted in a thorough and rigorous manner even if it is impossible to identify all safety concerns during clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with co-morbid conditions and those being treated with concomitant medical products. Therefore, postmarketing safety data collection and risk assessment based on observational data are critical for evaluating and characterising a product's risk profile and for making informed decisions on risk minimisation.

2.3

The present opinion is dealing with the Commission's proposals on amendments to the present Regulation only, whilst another opinion of the Committee is dealing with the amendments to the Directive 2001/83/EC (1).

2.4

The EESC is strongly in favour of significant improvements in the existing Community legal framework, given that the differences are emerged between the national legislative, regulatory and administrative provisions on medicinal products and that these differences could hinder intra-Community trade and affecting the good functioning of the internal market.

2.5

A lack of coordination would deny the Member States access to the best scientific and medicinal expertise for the evaluation of the safety of medicines and for risk minimisation.

2.6

The Committee has already pointed out that ‘a strong pharmacovigilence system is vital and believes that existing systems must be strengthened. All health professionals involved in the prescribing or dispensing processes, as well as patients, should participate in an effective post-marketing surveillance system applied to all medicines’ (2).

2.7

The EESC endorses the Commission's intention to establish an increased market surveillance by reinforcing monitoring procedures providing for clear roles and responsibilities for the key responsible parties and for a transparent EU decision-making on drug safety issues in order to deliver measures that are equally and fully implemented for all relevant products in EU.

2.8

The responsibility for health care is becoming increasingly shared with patients taking a more active interest in their own health and care options. The importance of involving patients in pharmacovigilance including direct patient reporting of suspected adverse reactions is recognised and the EESC welcomes the emphasis on creating and supporting ways of ensuring patient involvement at all levels.

2.9

The EESC recognises the benefit to EU citizens and patients of the new provisions for pharmacovigilance which will result in an improved access to health and medicines information and a proactive collection of high quality data on the safety of medicines. This collection and management of pharmacovigilance data in the EudraVigilance database must be fostered with new human and financial resources to become an interactive single point of receipt and delivery of pharmacovigilance information for medicinal products for human use.

2.10

The EESC is dealing with all the different aspects of the Pharmaceuticals Package of Proposals that are treated in various opinions (3) on specific subjects. To this effect an important and fruitful public hearing was held in Brussels under the chairmanship of President Bryan Cassidy with the participation of representatives of firms and of national and European organisations.

3.1

The objective of the proposals is to improve the protection of public health in the Community while enhancing the single market in medicinal products, by strengthening and rationalising EU pharmacovigilance and removing disparities between national provisions in order to ensure the proper functioning of the internal market for such products.

3.2

The proposals aim to contribute to the strategic goals of the Community framework for the authorisation, supervision and surveillance of medicinal products through:

3.3

The specific objectives of the proposals are:

3.4

The proposals underline the need for adequate funding of activities related to pharmacovigilance by the Agency through the collection of fees charged to marketing authorisation holders, the resources for the EMEA Telematics Master Plan and the overall impact on the EMEA budget.

4.1

Basic endorsement: The Committee endorses the basic objectives of the proposals of the achievement of the internal market in the pharmaceutical sector, improving the protection of public health as stated above.

4.1.1

In the context of the renewed Lisbon Strategy, the Committee reiterates the concern expressed about the importance of simplification of the regulatory framework to benefit citizen, patients, firms and society, and underlines the need of ‘an integrated approach in order to build advantage for the industry and patients as well as to stimulate its continued development as a major contributor to a dynamic knowledge-based, competitive economy in Europe’ (4).

4.2

Clear roles and responsibilities. The Committee underlines the importance that ‘all health professionals involved in the prescribing or dispensing processes, as well as patients, should participate in an effective post-marketing surveillance system applied to all medicines. This spontaneous reporting system should be particularly stringent for newly marketed medicines’ (5).

4.2.1

The Committee is convinced that the norms as they are now can be improved with the participation of all stakeholders since one of the shortcomings is the fact that there is a lack of knowledge or information regarding the different characteristics and risks which marketed medicines have.

4.2.2

The EESC strongly support clarification and codification of tasks and responsibilities across and between all stakeholders: Member State Competent Authorities, EMEA (including its committees), Commission and Marketing Authorisation Holders, including their Qualified Person for Pharmacovigilance. Another EESC opinion is dealing with the new proposals on codification.

4.3

Rationalising EU decision-making. The Committee endorses the establishment of a new committee to replace the existing Pharmacovigilance Working Party within the EMEA and believes that the setting up of such a committee, to specifically deal with pharmacovigilance issues across the EU, is a step in the right direction in order to harmonise safety signals across the EU.

4.3.1

The Committee would wish greater clarity and further refinement of some of the proposals, in particular: around the interface between CHMP and the new Pharmacovigilance Committee, patient and public involvement including patient reports of suspected adverse reactions, the role of an intensive monitoring list and the definitions for non-interventional studies.

The EESC would like to refer to the recently established Committee for Advanced Therapies (CAT) which specifically deals with licensing and post-marketing issues including pharmacovigilance and follow-up of efficacy and of advanced therapy medicinal products as defined under Regulation (EC) 1394/2007. This regulation was based on the need to have the required expertise to assess such complex and specialised products.

4.3.2

Therefore, the EESC questions whether a general pharmacovigilance committee will have the relevant expertise to regulate pharmacovigilance issues for specialised products, such as advanced therapy medicinal products. It is thus suggested that for these products, the CHMP through the CAT is consulted during the risk/benefit assessment.

4.3.3

The contribution of the future new Committee on Pharmacovigilance for safety analysis should be reconsidered within the more general framework of risk-benefit ratio analysis which is and should continue to be the responsibility of the CHMP.

4.4

Patient first. The patient must be at the centre of the proposed new regulatory framework. Today EU legislation does not provide for sufficient harmonised rules in this area and as a consequence EU citizens have unequal access to information across the EU. Patients must be encouraged to report adverse reactions directly to the national authority for all medicines instead of to the marketing authorisation holder. The Committee is in favour of direct reporting as an essential tool to empower patients and to improve their involvement in the management of their own health.

4.4.1

It is important that clear and transparent safety information, namely a pictogram (6) to help consumer distinguish immediately intensively monitored drugs, the conclusions and recommendations of the Periodic Safety Update Reports (PSURs) and medicines consumption data are made public, respecting confidentiality on data protection and commercial interest. Eudravigilance has to be regularly updated and easily and fully accessible by patients.

4.4.2

The Committee believes that the patient information leaflets need to be designed to convey potential adverse reactions more clearly with the introduction of safety information on the package leaflet and the warning for medicines under intensive surveillance. In any case, information dumping must be avoided and information must be tuned on the different audience needs and supported by an appropriate use of internet: on this question the EESC is providing a specific opinion (7).

4.4.3

The final aim for the Committee must be the completion of a effective single European market in pharmaceuticals built on the needs and interests of European patients and citizens, in terms of availability of safe, innovative and accessible medicines needed by patients under a unified EU approach that reduce the dependence of the market on the decision-making processes in the 30 different national governments.

4.5

Transparency and communication. In supporting the current proposals to enhance communication with healthcare professionals and patients via product information, the Committee strongly suggests that this opportunity is taken to make both PILs and SPCs (8) more useful, user friendly and coherent.

4.5.1

Pharmacovigilance information for medicinal products for human use needs an interactive European database network. The EESC is strongly in favour of strengthening the Eudravigilance database as the single point of receipt of information on adverse reactions in human beings arising from use of the product within the terms of the marketing authorisation ‘as well as from any other use, including overdose, misuse, abuse, medication errors, and those occurring in the course of studies with the medicinal product or after occupational exposure’.

4.5.2

Transparency should be favoured in acts and decisions at all levels of the agencies and of the EMEA. An important aspect of that is the accurate and timely communication of emerging data on risk as an essential part of pharmacovigilance. Risk communication is an important step in risk management as well as a risk minimisation activity. Patients and healthcare professionals need accurate and well communicated information about the risks associated with both the medicinal product, and the condition for which it is being used. (9)

4.5.3

The EESC feels that the key message is to bring the ever-growing importance of a transparent policy concerning the public access to the data and that such requests must be provided within the delay prescribed by the legislation. It is vital for public confidence that a transparent access policy is agreed by all Member States. The Committee would like to have a clearer justified reason on the denied public access to the transparent and non-promotional post-marketing studies or to the results of these studies while launching the EU safety web-portal by the EMEA. The EESC underlines its strong support for guiding principles and oversight of a subset of Post-authorisation safety studies -PASS (10), in line with Articles 24, 26 and Article 57 (1)(d) of Regulation (EC) No 726/2004 (11).

4.5.4

The Committee supports the proposal for the EMEA to carry out all literature monitoring, since this would provide a significant reduction in duplication of work. The Agency shall monitor selected medical literature, in cooperation with the Marketing Authorisation holders, for reports of all suspected adverse reactions to medicinal products for human use containing certain active substances to be entered into the Eudravigilance database and in a published list of active substances being monitored.

4.6

Simplification of procedures. The EESC welcomes the proposed initiative to reduce administrative burden with respect to ADR reporting and to decrease the current duplicate reporting system that exists across the EU for Individual Case Summary Reports via both paper and electronic copies across different Member States. The Committee believes that it would be useful to introduce a specific legal obligation to follow the requirements of the International Conference on Harmonisation — ICH (12) for electronic submission.

4.6.1

Furthermore, it is important to point out that, at present, a lot of precious resources for pharmacovigilance at a National Competent Authority — NCA level are used up acknowledging and dealing with Individual Case Safety Reports — ICSRs — sent by companies with an unuseful duplication of activities. These resources could be better utilised by encouraging a stronger collaboration between the authorities, maximising the expertise available, work-sharing and simplifying the administrative aspects of the activities related to the submission and administration of all the safety reports.

4.6.2

The EESC underlines the importance of simplified procedures for small and medium-sized enterprises (SMEs) and asks for the optimisation of the ‘SME office’, providing financial and administrative assistance to micro, small and medium-sized enterprises (SMEs) pursuant to Commission Regulation (EC) No 2049/2005.

4.7

Coordination of Member States’ and EC actions. As international markets expand and companies operate more and more on an international basis, the task of regulatory authorities to assess compliance with legislation and monitor the safety of medicines becomes increasingly important and resource-intensive as ‘the EU pharmaceutical industry operates in a global economy’ (13). In response to this overall situation and to address the challenges of the internal and international market, which can pose potential risks to public health, there is the need of intensified global cooperation on two different levels:

4.7.1

As the Commission Vice-President Günter Verheugen (15) said: ‘The pharmaceutical sector makes an important contribution to European and global well-being through the availability of medicines, economic growth and sustainable employment’.

4.7.2

The increasing internationalisation of the sector and the ‘shortcomings in the EU pharmaceutical market which affect patients’ access to medicines and to relevant information is hampering the competitiveness of the industry’ (16). On this line, the Committee strongly recommends:

4.8

Independent external evaluation of EMEA achievements. The EESC requests that, in its report for 2015, the EMEA presents an independent external evaluation of its achievements on the basis of its founding Regulation and the work programmes together with an evaluation assessment of the working practices and the impact of the new mechanism provided for the CHMP, the CAT and the new Pharmacovigilance Committee, taking into account the views of the stakeholders, at both Community and national level.

16.12.2009   

EN

Official Journal of the European Union

C 306/28

1.1

The EESC welcomes the Commission initiative, which aims to improve the pharmacovigilance system and its harmonisation at the EU level, and gives priority to patients and their health needs.

1.2

The EESC emphasises that it is important to base the gradual strengthening of the pharmacovigilance instrument primarily on transparency and the simplification of procedures in an increasingly concrete framework of greater harmonisation between Member States’ procedures in order develop a common methodology, since the EESC is convinced of the need to work towards the goal of free movement of medicinal products and the completion of the single market in this sector.

1.3

The EESC is therefore in favour of the improvement to the legislative framework in force, which amends and substantially enhances Directive 2001/83/EC, discussed herein, and Regulation No 726/2004 (on which a specific opinion (CESE 1023/2009) has been drawn up — rapporteur: Sylvia Gauci). These measures take account of limitations encountered during the application of the current provisions and aim to replace existing national rules, which are liable to present — often unnecessary — barriers to the free movement of medicines in the EU and hinder a practical risk reduction process.

1.4

The EESC emphatically endorses the objective whereby all stakeholders are directly involved in the pharmacovigilance process, including not just professionals in the sector and the relevant public sector bodies but also patients themselves, who thus become active partners in the risk reduction process and play an increasingly active part in therapeutic choices that are more in tune with their health needs. The EESC believes that the new elements introduced by the proposals must neither call into question, nor weaken existing structures and procedures at local level, especially those that involve the patient and health professionals, provided that common parameters for comparable data are assured in transparent and rapid procedure.

1.5

The EESC points out that this initiative is fully in line with the renewed Lisbon Strategy, which, in addition to simplifying procedures, seeks to foster continuous development of the pharmaceutical sector in order to create a sector founded on knowledge-based economic growth that can contribute significantly to high-skill employment and fully respond to the healthcare demands put forward with increasing insistence by civil society.

1.6

It considers the establishment of an EMEA committee with pharmacovigilance as its specific and sole task, and the availability of a continuously updated EU database on potential risks (Eudravigilance) that is easily accessible to all citizens to be the strong points of the legislative measure, which follows a request for increasingly simple and more practical instruments for the preparation of the information leaflets that accompany all pharmaceutical products.

1.7

As a result, the EESC's assessment is positive since the initiative will reduce administrative burdens and simplify procedures for reporting adverse reactions, not least by cutting back on the current paper-based procedure for reporting between Member States.

1.8

Given the importance of pharmacovigilance for public safety in ensuring the citizens’ right to safe and effective pharmaceutical products, the EESC calls for pharmacovigilance to be included in its own right in EU research programmes, starting with those set up under the Seventh Framework Programme, via programmes directly involving the EU, its Member States, industries, universities and public and private research centres.

1.9

The EESC believes that once the key issue of pharmacovigilance has been dealt with, a number of issues affecting this sector will remain unresolved such as, for instance, the price of pharmaceutical products, the varying availability of medicinal products within the Member States themselves, issues relating to the use of generic medicines and their harmonised distribution, protection against counterfeit medicines and illegal supply chains, the safe importing of active ingredients and excipients, etc. These problems have to be addressed in order to achieve the intended freedom of movement of medicinal products in the European Union and the completion of the single market.

2.1

Civil society's consistent calls for ‘good health’ and a better quality of life place the need to provide an adequate response to healthcare issues at the top of the agenda, starting with prevention and the proper use and monitoring of medicinal products.

2.2

As one of the key tools for protecting public heath, pharmaceuticals are a valuable resource and their discovery and adequate availability are a key aspect of public heath protection. Their proper use is a key contributor to the steady rise in life expectancy while, at the same time, it helps to cut down on healthcare expenditure insofar as it reduces the cost of hospital or specialist care.

2.3

The need to review pharmacovigilance legislation was revealed by a close analysis of experience acquired and an independent study carried out in 2004 by the Commission. This report revealed several shortcomings and the need to better define the rules governing this field. As a result, the Commission decided to review existing pharmacovigilance legislation in order to bring it into line with gradual advances in general legislation on the free movement of medicinal products and making use of medicinal products safer for EU citizens.

2.3.1

Since EU pharmacovigilance legislation was first introduced in 1965, only piecemeal and limited action has been taken. In view of the limitations encountered on a day-to-day basis, we are now faced with the need for a qualitative leap in the definition of pharmacovigilance legislation, not least in order to prevent this issue from creating barriers, which are often unnecessary, to the free movement of medicinal products in the EU, which is absolutely unacceptable.

2.4

The rules currently in force are Regulation (EC) No 726/2004 of 31 March 2004 and Directive 2001/83/EC. The Directive under consideration seeks to amend the latter. Both legislative instruments have made a useful contribution to monitoring the side effects of pharmaceutical products, but the study carried out and a subsequent consultation involving all stakeholders have shown that there is room for improvement through more precise definition of these rules.

2.5

The proposed amendments fall within a strategic framework for marketing authorisations for medicinal products, and subsequent supervision and surveillance to ensure a high level of public health protection and progress towards the completion of the internal market for the pharmaceutical sector, bearing in mind the social dimension of pharmaceutical products, whose purpose should always be to benefit patients and their interests.

3.1

In its earlier opinions, the EESC has systematically stressed the importance of Europe's competitive and highly innovative pharmaceutical industry, which over the last 50 years has been among the most high-tech, high-innovation and high-skill employment sectors, with a corresponding added value and growth rate for the modern industrial framework.

3.2

However, the positive effects of medicinal products are also accompanied by unintended, noxious side effects resulting from their use and from medication errors, including the misuse and/or abuse of the product. Misuse of medicinal products accounts for 5 % of all hospital admissions.

3.3

The responsibilities inherent in such a role are fundamental and warrant considerable attention in order to safeguard public health properly, especially since we are confronted with a marketing process in which the adverse effects of new molecules are only detected after authorisation has been granted and the new medicinal product is therefore already on the market.

4.1

The term pharmacovigilance is used to define the pharmacological process dedicated to the detection, assessment, understanding and prevention of the adverse effects of medicinal products, and in particular, of short and long-term side effects.

4.2

Risk assessment during the development of medicinal products should be thorough and rigorous, even if it is impossible to identify all safety risks during clinical trials. Once a medicinal product enters the market, there is generally a substantial increase in the patients exposed to it, including patients who suffer from more than one condition at the same time or who are being prescribed a number of different types of medication.

4.3

Adverse drug reaction (ADR) is an expression that describes the unwanted, negative consequences associated with the use of given medication. An ADR could be identified as any unexpected or dangerous reaction to a drug. The meaning of this expression differs from the meaning of ‘side effect’, as this last expression might also imply that the effects can be beneficial. An ADR is a ‘response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function’.

5.1

The Directive aims to strengthen and rationalise the pharmacovigilance system, especially with respect to clarifying roles and responsibilities, by amending Directive 2001/83/EC, which has served so far as the legal reference framework for medicinal products for human use.

5.2

This is why the Commission has decided to amend the existing EU legislation. The objectives pursued are as follows:

5.3

The Commission explains that the proposals are consistent with the overall objective of the free movement of medicinal products, which is to remove disparities which still exist between national provisions by reconciling a high level of public health protection with the proper functioning of the internal market for medicinal products.

5.4

All interested parties, i.e. patients, healthcare professionals, the competent authorities of the Member States and the industry, were widely consulted on the proposals. The impact assessment suggested increasing the clarity, efficiency and quality of the current EU system of pharmacovigilance with a view to public health improvements and overall cost savings to the EU pharmaceutical sector.

5.5

In order to establish clearer roles and responsibilities, the new provisions clarify and codify the tasks and responsibilities of the interested parties. Although the pharmacovigilance system will remain the province of the individual Member States, marketing authorisation holders will have to report all available data exclusively to the Community's Eudravigilance database, thereby automatically ensuring an EU-level assessment of any related issues.

5.6

These strengthened safety measures for medicinal products should increase the trust of patients and healthcare professionals by including a new ‘key information’ section in the summary of product characteristics and the package leaflet which accompany every medicinal product.

5.7

The responsibilities of the agency will be bolstered by the establishment of a new scientific committee responsible for pharmacovigilance, as set out in Article 27 of the new provisions, with the additional role of assessing risk, providing support both to the Committee for Medicinal Products for Human Use within the Agency and the coordination group of Member States.

5.8

Under the new provisions, marketing authorisation holders will have to keep a ‘pharmacovigilance system master file’ and to provide a risk management system for each new medicinal product authorised, which should be proportionate to both the identified and the potential risks.

5.9

The new proposal makes an additional improvement to pharmacovigilance by strengthening the electronic infrastructure for reporting adverse events connected with medicines (Article 24). The scope of periodic safety update reports sent to the Eudravigilance database will be amended so that they serve to analyse the risk-benefit balance. Provision has also been made for the regulatory follow-up of periodic safety update reports. Thus, Eudravigilance will provide a clear link between pharmacovigilance evaluations and the review and updating of marketing authorisations, while at the same time giving real-time access to all information on the database.

5.10

The new legislative proposal sets out to simplify the reporting of adverse drug reactions, making periodic safety update report submission proportionate to risks. This will facilitate the reporting of adverse and unintended reactions to medicinal products taken in normal doses as well as from overdose or medication errors by both healthcare professionals and patients. It combines rules for reporting adverse reactions, applying the same provisions to medicines authorised under the centralised procedures and those authorised by individual Member States.

5.11

Section 1 of Chapter 3 concerns the recording and reporting of unintended effects. Subsequent sections provide a detailed description of the other procedures for reporting and evaluating pharmacovigilance information and more detailed technical information. The second section covers ‘Periodic safety update reports’ the third ‘Community procedure’, setting out in Article 107 the procedure each Member State must follow in order to suspend or revoke marketing authorisation because serious deficiencies have been found, and the fourth section ‘Publication of assessments’; this is an important section since it concerns the supervision of post-authorisation safety studies for medicinal products.

6.1

The proposal is based on Article 95 of the EC Treaty, which prescribes the codecision procedure and is the legal basis for achieving the free movement of goods for medicinal products for human use. Moreover, since the Amsterdam Treaty came into force, Article 95 has been intended to remove barriers to intra-Community trade and therefore justifies EU-level action in the area of medicinal products.

7.1

EU pharmacovigilance measures guarantee the best protection of public health through the application of the same standards across the Community. They are also in line with the proportionality principle insofar as they seek to safeguard public health without imposing unnecessary administrative burdens by building on existing structures, procedures, resources and practices. The proposal envisages that the efficiency of the EU pharmacovigilance system will be increased and costs reduced due to the resulting simplification.

7.2

The objective of improving the safety of medicines placed on the Community market can be best achieved by applying the subsidiarity principle as set out in Article 5 of the Treaty. Under this article, the best way to achieve these objectives is at EU level, as the requirements for accreditation and market surveillance relating to the marketing of pharmaceutical products fall within the scope of Article 15(2) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008.

7.3

Furthermore, since the proposal provides for the simplification of the Community pharmacovigilance system, it falls under Annex 1 of the Commission Legislative and Work Programme for 2008.

8.1

Recognising the major, positive contribution that medicinal products make to the citizens’ quality of life, the EESC has always supported any initiatives liable to increase safety in the use of medicinal products, which is a fundamental aspect of public health protection.

8.2

The EESC's initial assessment of the decision to overhaul existing legislation in the light of previous experience is positive insofar as the objective of such a strategy for improving safety through the proposed amendments has been a key element of earlier EESC opinions on the various aspects of pharmaceutical policy.

Moreover, the EESC takes a positive view of the Commission's efforts towards simplification in the interests of individual patients as well as companies. It also endorses efforts being made to complete the single market in a sector as complex and important as the pharmaceutical sector.

8.3

The EESC endorses the amendments that clarify and improve the definition of terminology previously used in Directive 2001/83/EC. The new wording will help solve problems relating to previous interpretations, which sometimes gave rise to doubt and inconsistencies in application. In particular, with regard to Article 1, the EESC welcomes improvements in defining the meaning of ‘adverse reaction’, as used in point 11, and the way in which it has been distinguished from the use of ‘suspected adverse reaction’ in point 14 referred to in the same article. Its definition should take account of the risk of confusion with the International Conference on Harmonisation (ICH) definition.

9.1

In the same vein, the EESC takes a positive view of clarifications set out in the new point 15 with respect to the definition of ‘post-authorisation safety study’, and the new definition in point 28 regarding the ‘risk management system’, followed by a detailed description of the required documentation in the new Article 8(iaa) and point 28c) on the ‘pharmacovigilance system’ and point 28d) on the proposed master file, which is defined in greater detail in Article 8(3).

9.2

The EESC draws particular attention to Article 21(a) since the new definition contributes to safety by making the marketing authorisation of the new pharmaceutical product subject to the provision of substantial documentation to establish compliance with the key safety measures set out in Article 22, subject to certain conditions established by the competent authorities regarding the safety of pharmaceutical products.

9.3

Article 22(a) requires the national competent authority to require a marketing authorisation holder to conduct post-authorisation safety studies if there are concerns about risks. On the basis of documents submitted by the marketing authorisation holder, the national competent authority may withdraw or confirm authorisation. The EESC welcomes the provisions of Article 23, which, based on the findings of the study, oblige the authorisation holder to immediately inform the national competent authority of any prohibition or restriction imposed by the competent authorities of any other country.

9.4

Article 101 clearly sets out the role of Member States in the direct management of a pharmacovigilance system, making them responsible for the collection of information on the risks of medicinal products as regards patients’ or public health in a single database, i.e. Eudravigilance, in accordance with detailed procedures set out in Article 24. A competent authority is to be appointed in each Member State with responsibility for collecting data on adverse reactions relating to medicinal products on the basis of conditions for authorisation and other uses including overdose, misuse, abuse and medication errors.

9.5

The EESC believes that Article 102 contributes to improving patient safety in the use of medicinal products since it enables Member States to impose requirements on doctors, pharmacists and other healthcare professionals in respect of the reporting of suspected or identified adverse reactions.

16.12.2009   

EN

Official Journal of the European Union

C 306/33

1.1

The Committee welcomes the proposed amendment of the regulation in question as it responds to the objectives of simplifying and harmonising information for patients.

However, the EESC considers that the significant variations from one Member State to another in rules on the legal status of prescription and dispensing of medicines are an obstacle to good, understandable information on medicines.

Accordingly, the EESC calls on the Commission to work towards harmonising the determination of the legal status of prescription and dispensing of medicines containing the same active ingredient(s), at the same dosage, for the same therapeutic indications, presented in the same way and under the various registered trade marks in existence in the Member States.

1.2

It has always supported legislative measures aimed at simplifying rules and extending them in a harmonised way to all EU Member States. As well as being advantageous to patients, this also benefits SMEs, which often find their hopes dampened by bureaucracy.

1.3

In order to achieve an ever-higher standard of information for patients, the EESC, in addition to the measures proposed by the Commission, proposes that the package leaflets that accompany every pharmaceutical product should contain information in a simple and direct visual form based on bands of colour for reporting for instance: benefits (green band), contraindications (yellow band), and possible risks (red band).

1.4

It would also be worthwhile having a list of generic medicines (pharmaceutical products with the same active ingredient whose patents have expired). This list could be put together by the Agency and supplied to pharmacies and all distribution centres open to patients.

1.5

Though aware that computer usage is not yet universal among the EU public, the EESC believes it would be useful to launch an additional procedure for providing patients with necessary information on medicines via the internet. This information, complementing rather than replacing that currently available, should be checked and should carry a label of Community recognition, in order to prevent abuses or misinformation.

1.6

While reiterating its call for continued development of the policy of streamlining bureaucratic procedures and patient information, the EESC calls on the Commission to table further legislative measures to cover all those areas of the pharmaceutical sector that still present difficulties in terms of non-harmonised application in individual Member States, as this impedes the achievement of full and free movement of medicinal products in the EU.

2.1

The proposal in question amends current practice as provided for under Regulation (EC) No 726/2004 with regard solely to information for the general public on medicinal products for human use subject to medical prescription.

2.2

The amendments concern the rules on direct information for consumers on medicinal products subject to prescription and are aimed at securing the proper functioning of the internal market for medicinal products for human use. While amending the rules on information for the public on medicinal products for human use, the regulation also reaffirms the legislative ban on advertising, in line with the provisions of the Directive published in OJ L 311 of 28 November 2001 and the recent amendment set out in Directive 2008/29/EC.

2.3

The need to adjust the provisions of the existing regulation dates back to the Communication from the Commission to the European Parliament of 20 December 2007. That report on ‘current practice with regard to information provision’ noted that divergences in Member States’ rules and practices regarding the provision of information had in some cases led to disparities and varying public access to relevant information.

3.1

Draft Regulation COM (2008) 662 final aims to:

3.2

The proposed amendments are aimed at filling the gaps in the current application of pharmaceutical legislation provided under Regulation (EC) No 726/2004 on information for the public on medicinal products for human use, more specifically:

3.3

A new Title VIIIa is aimed at addressing disparities by ensuring harmonised, good quality, non-promotional information. The aim is to do away with the unjustified differences in the case of medicinal products authorised under Title II of Regulation (EC) No 726/2004, which provides for a single summary of product characteristics and applies Title VIIIa of Directive 2001/83/EC to those products.

3.4

By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive is to be vetted by the Agency prior to its dissemination (Article 20 b), COM(2008) 662 final).

3.5

Therefore, the tasks of the Agency provided for under Article 57 (1) will include a letter u), that of ‘delivering opinions on information to the general public on medicinal products for human use subject to medical prescription’.

3.6

The third paragraph of Article 20b states that the Agency may object to the information submitted within 60 days of receipt of the notification. In the absence of opposition, the information may be published, in accordance with the principle of ‘silence implies consent’.

4.1

The Committee for Medicinal Products for Human Use (CMPH), which is part of the Agency, is responsible for preparing opinions on all matters regarding the evaluation of medicinal products for human use. All decisions on authorisations are taken on the basis of scientific criteria relating to the quality, safety and efficacy of the medicinal products concerned.

4.2

EMEA is made up of various committees, including the Committee for Medicinal Products for Human Use. The Agency's tasks are to:

4.3

The present EC regulation complements:

5.1

According to the Commission, these modifications are in line with the EU's other policies and objectives. Meanwhile, the choice of Treaty Article 95 appears to be appropriate as that is the legal base for Community pharmaceutical legislation. In addition, the content of the proposed modifications responds to the requirements of Article 5 of that Treaty with regard to the principles of both subsidiarity and proportionality.

6.1

The EESC has always supported legislative measures aimed at simplifying rules and ensuring they are adopted in all EU Member States in a harmonised way.

6.2

It therefore welcomes the proposed amendment of the regulation in question as it responds to the objectives of simplifying and harmonising information for patients while also simplifying matters for business, starting with SMEs.

6.3

The EESC believes it would be worthwhile launching an IT-based procedure for checking information via the internet, complementing the provisions currently available. It would also be useful to improve the visual format of the leaflets that accompany all pharmaceutical products (see point 1.3).

6.4

The EESC calls on the Commission to table further legislative measures to cover all those areas of the pharmaceutical sector that still present difficulties in terms of non-harmonised application in individual Member States, not least regarding the issue of sale price and the legal status regarding prescription and dispensing, where this impedes the achievement of full and free movement of medicinal products in the EU.

6.5

The EESC would like to know why the amendment of Regulation (EC) 726/2004 ‘laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency’ has required two separate but parallel legislative initiatives. The first Commission document (COM(2008) 664 final) provides for amendments regarding pharmacovigilance, while the second (COM(2008) 662 final) addresses information for the general public on medicinal products for human use subject to medical prescription.

6.6

The EESC takes a negative view of this compartmentalisation by the Commission, as two separate legislative measures constitute a waste of procedural resources and could cause delays in securing a single regulation.

16.12.2009   

EN

Official Journal of the European Union

C 306/36

1.1

Article 95 TEC rightly forms the legal base for the recast directive, which standardises conditions for the production and distribution of electrical and electronic equipment in the internal market. There are two reasons for adopting this legal form for the directive; this is a recast of a directive and it is the Member States that are responsible for implementing and monitoring the directive, in line with the principles of subsidiarity and proportionality.

1.2

The Committee considers, however, that monitoring the application of the recast directive should aim to ensure that harmonisation of its implementation in the internal market is as comprehensive as possible, in order to avoid potential administrative complications in a cross-border context and any distortions to competition that might ensue.

1.3

As regards possible changes to the list of toxic or dangerous substances whose use is prohibited or heavily restricted, the EESC can only accept the comitology method if the stakeholders concerned are consulted and an impact assessment is carried out for each substance added to or removed from the list.

2.1

By proposing to replace the WEEE (Waste Electrical and Electronic Equipment) Directive with a recast directive intended to boost the waste recovery and processing rate, to extend the scope to medical and hospital equipment and monitoring instruments and to promote the re-use of reparable goods, the Commission aims to ensure better environmental protection and a reduction in administrative formalities. The proposal for a directive aimed at restricting the use of dangerous substances in electric and electronic equipment (RoHS), which is the subject of this Committee opinion, is complementary to and interdependent on the recast WEEE directive and must consequently be recast itself.

2.2

Where toxic or dangerous substances are concerned, the Commission's staff consider that this recast will result in modest but clear overall benefits. Furthermore, the options it recommends will have a considerable cumulative effect on clarifying the directive and harmonising its implementation and execution, thus contributing to better regulation.

2.3

The aim is in particular to extend the scope of the two directives by adding medical devices and monitoring and control equipment to the other equipment already covered by the earlier directives. The emphasis is also on the need to re-use some parts of equipment rather than treating them as waste. The appropriate declarations and proof must be provided to make the distinction between recycled equipment and waste.

2.4

The recast RoHS directive retains its legal base (Article 95, concerning the internal market), and the recast WEEE directive retains its own legal base (Article 175, concerning the environment), in line with their respective goals, which remain basically the same.

2.5

The appendices to the recast RoHS directive detail the type of equipment covered (appendices I and II) and form the new reference point for the recast WEEE directive. Toxic or dangerous substances whose restrictions are covered by the RoHS directive remain unchanged as regards their nature and acceptable threshold quantities. Scientific and technical developments, as well as any possible derogations, will be taken into account by the comitology with scrutiny procedure.

2.6

According to the Commission, the environmental benefits will probably be considerable: several tonnes of heavy metals covered by the RoHS directive (> 1 400 tonnes of lead and around 2,2 tonnes of cadmium) are used in medical devices and monitoring and control instruments, which in terms of weight, accounts for 0,2 to 0,3 % of waste electrical and electronic equipment. Where waste is poorly managed, these substances can be released into the environment (only 49,7 % of medical device waste and 65,2 % of waste from monitoring and control instruments are collected separately); Restricting the use of these substances under the RoHS directive will, in the medium and long term, help to eliminate them from goods and the resulting waste. A more detailed analysis suggests that, even in scenarios indicating higher recycling rates, including this equipment in the scope of the RoHS directive does benefit the environment.

2.7

Harmonised definitions in all related directives will also help to ensure better implementation and the elimination of administrative barriers (see point 3.3 below) and excessively divergent implementing procedures.

3.1

The technique of recasting instruments such as the WEEE and RoHS directives can, as in the case now under consideration, lead to a thorough overhaul of existing legislation.

3.2

This recast should address all uncertainties regarding scope and definitions and the different practices in the Member States concerning product conformity in addition to the potential obsolescence of the directives as a result of the new REACH regulatory framework. Genuine harmonisation is crucial to limiting the implementation costs of the measures put forward, in addition to the administrative burden.

3.3

The complementarity and coherence of the two directives with other Community legislation (a common framework for the marketing of products (1), REACH (2) and energy-consuming products (3), which concerns equipment design) should be stepped up.

3.4

The Committee is pleased to note that no changes have ultimately been made to the list of prohibited or restricted substances in electrical and electronic products, which upholds an equivalent level of protection for workers and consumers.

3.5

The EESC consequently reiterates the need for vigilance concerning a number of illegal transfers of dangerous waste to countries that are not technically equipped to process them properly, which presents serious environmental and health risks for those countries. The processing of electronic waste already poses serious public health risks in some of these countries and this situation could worsen if the preliminary waste treatment proposed in the WEEE directive is not carried out properly and because extending the scope to categories 8 and 9 adds new risks.

3.6

The Committee notes that the list of prohibited or restricted substances is not changed by the proposed recast. When considering whether to authorise potential replacement products for the most toxic or dangerous substances, it must be ensured that they do not themselves present any risk. Possible exemptions should only apply to substances that are absolutely irreplaceable in the light of current knowledge and technological developments and with all the necessary protection and precautionary provisions in place.

3.7

The scope defined in appendices I and II of the recast RoHS directive can be amended by the Commission under the comitology with scrutiny procedure, but the EESC considers that any substantial changes at a later date should be subject to new impact assessments and to new preliminary consultations. The Committee welcomes the use of the REACH methodology for the possible introduction of new prohibitions on substances.

3.8

The EESC recognises that harmonising definitions horizontally, covering all of the directives concerned (see point 3.3 above) is a measure that will bring clarity and reduce administrative costs.

3.9

The Committee also acknowledges that setting a reasonable deadline for exempting certain substances (four years) is likely to boost the quest for alternative solutions, whilst providing sufficient legal certainty for manufacturers.

3.10

The EESC is aware that the amended regulatory framework has some influence on business growth and employment and welcomes the improved coherence between the two recast directives and the legislative and administrative simplification that they promote.

3.11

The Committee welcomes the extension of the RoHS directive’s scope to two additional categories of equipment (categories 8 and 9 covering medical devices and monitoring and control instruments) and the adoption of the principle of partial re-use of the equipment collected), because it considers controls that help to identify the waste from recycled devices, on the basis of the declaration and monitoring, to be proportionate.

3.12

The EESC is also satisfied with the harmonisation of the definitions of the economic operators concerned with those of the ‘product marketing’ package and with the new definitions that have been added (concerning medical devices, for example).

3.13

The Committee very much hopes that harmonisation of the Member States’ implementation will be much more effective than it has been to date in the context of the previous directives before they were recast. An evaluation in a few years’ time would be desirable to ensure that the stated aims have indeed been met.

16.12.2009   

EN

Official Journal of the European Union

C 306/39

1.1

The objective of the review of the WEEE directive should be to provide positive impacts, both environmental and economic. This will benefit the environment, business operators and European citizens.

1.2

Experience has shown that the aim of the WEEE Directive, which is to achieve a functional internal market approach to waste management, has not been realised.

1.3

During the implementation of the WEEE Directive there have been many problems with many differences between member states.

1.4

These differences are partly caused by ambiguous definitions in the Directive but also by the freedom in implementation given to the Member States in Article 175 of the EC Treaty.

2.1

To date, the Committee can summarise the issues that need to be looked at as a result of the review of the WEEE Directive, as follows:

2.2

The WEEE Directive has a simplification potential by reducing the administrative burden on the market operators.

2.3

In reviewing the Directive, the European Union together with national authorities should ensure that the Directive creates a level playing field across all EU countries. A dual legal base of articles 95 and 175 of the EC Treaty would be desirable, whereby provisions related to the scope, definitions, product requirements and producer responsibilities related to the putting on the market of new products should fall under the legal base of article 95 of the Treaty and provisions related to targets and waste treatment under article 175 of the EC Treaty.

2.4

All actors in the chain, including producers, importers, retailers, traders, scrap dealers, should face the same responsibilities when dealing with WEEE.

2.5

The review of the Directive should allow for a better interaction between provisions for the protection of the environment on the one hand and rules that affect the smooth functioning of the Internal Market on the other.

2.6

In particular, the producer definition should not lead to more barriers to the Internal Market. This will be more in conformity with recent case law of the European Court of Justice that requires that the environmental protection does not run counter to the principles of the Internal Market. The definition of producer as proposed in article 3(j) of the WEEE recast proposal should also tie in to the extent possible with relevant definitions provided in Decision 768/2008/EC, while acknowledging the specific obligation that arises from the WEEE Directive, namely that registration as well as financing of collection and recovery are not characteristics of products (e.g. composition, ingredients, environmental impact), but additional obligations which have to be fulfilled at national level exclusively (i.e.: market surveillance and enforcement).

2.7

A revised Directive should not create any obstacles to the practice of sharing costs of WEEE management on the basis of current market shares. The way forward for Annex II is to allow interested parties to continue developing treatment standards. Currently, market-share based collective systems have proved successful in managing WEEE properly.

2.8

The Directive should fulfil its social aim to protect the environment and reduce the impact of waste on human health. Tackling the electrical and electronic waste stream in the EU in a cost-effective manner should help eradicate the shipment of this type of waste to third countries, where the environmental standards are lower and the risks for the manpower handling this waste are higher.

3.1.1

The Committee agrees with the new producer definition, but at the same time points out that this definition may lead to free-riders and distortion of competition.

3.1.2

It is intended to ensure a smooth functioning of the internal market. In this regard, the EESC appeals to the Commission to simplify the procedures, whilst blocking the way for abuse by free-riders.

3.1.3

The amended producer definition, in conjunction with the clarification of the terms ‘making available on the market’ under Article 3(o) new and ‘placing on the market’ under Article 3(p) new allows operators to voluntarily undertake specific actions without facing the risk of having to bear costs linked to the end of the life of the product.

3.1.4

By distinguishing the role of each operator, businesses can anticipate costs and thus take up a clearer part of responsibility as a result of their involvement in the supply chain of electrical and electronic equipment.

3.1.5

For the practical implementation, it must be possible for Member States to impose national obligations to the natural or legal persons who are placing products onto their national markets for the first time from third countries as well as from countries inside the Community (intra-community trade). Therefore, Member States may put in place proportionate provisions that allow them to identify these persons and have the possibility to ask these persons to provide the registration and the financing of the management of WEEE arising from their sales.

3.1.6

The Committee believes that the most positive environmental improvements and highest cost-efficiency, as a result of a clear producer definition, can be realised in the following ways:

3.2.1

The take back schemes for WEEE are a necessary step to collect WEEE from private household equipment at a large scale.

3.2.2

The Committee insists that such waste can be returned to the distributor free of charge on a one-to-one basis as long as the equipment is of equivalent type and has fulfilled the same functions as the supplied equipment.

3.2.3

The Committee believes however that consumers should be made aware about the scope of their rights, in order to avoid confusion about the role of the market operators. Indeed, market operators should not be regarded as waste collectors at the expense of the customer, without any limits. In particular, market operators should remain free to frame their take back obligations as long as the take back did not happen at the moment of the delivery of the purchased good. The Committee thinks that this will save transport and manpower costs to businesses. These savings make sense from an environmental and a competiveness point of view.

3.3.1

The Committee agrees with revisiting the current collection target. A collection rate of WEEE based on sales volumes, however, is inappropriate, since in almost every case, products have a much longer lifetime than one to-two years and therefore they do not come to recycling two years after sale.

3.3.2

Due to the fact that materials are more valuable now than five to ten years ago. WEEE with a net value (i.e. a high metal content) disappears from the established collection routes. The consequence is that such WEEE collected is not reported in the official WEEE channel. Such leaked WEEE goes either to bad treatment, or to no treatment/landfill, or to illegal export, or to good treatment or to legal export. Precise figures on the destination of such leaked WEEE are not available today (see Environmental Agency Report of March 2009).

3.3.3

The Committee believes that in the future, all market operators must be held responsible for management of WEEE over which they must gain more control.

3.3.4

The Committee acknowledges that the success of meeting collection targets depends on factors outside the sole control of producers, ranging from availability of collection points to the volume of WEEE generated by the end user.

3.3.5

The Committee therefore believes that producers should not be held liable alone: studies have shown that there are large flows of WEEE collected and treated outside the official WEEE systems and that there are many stakeholders, other than producers, that can influence the volumes collected and recycled.

3.3.6

The Committee underlines that the review of the WEEE Directive should aim at maximising its environmental results (collect more) and increasing the costs efficiency of WEEE treatment (treat better).

3.3.7

The Committee believes that if collection targets are measured at the moment the WEEE reaches the recycling systems, the operation of parallel flows makes it impossible for producers to collect enough WEEE to achieve the target. The Committee therefore suggests that a more effective way to reach the collection targets would be to measure when the material reaches the recycler, as this method would capture all the WEEE flows, rather than the producer flows in isolation.

All in all, the Committee underlines that parallel flows need to be subject to regulation, to ensure that all WEEE is recycled in accordance with the requirements of the Directive. In particular, that such other actors than EEE producers should be obliged to report on WEEE collected by them.

3.4.1

The Committee believes that the responsibility of financing in respect of WEEE from private households should not be exclusively placed with the producers, as suggested by the Commission proposal in the new article 12.

3.4.2

The Committee deems it important that producers are given incentives to choose between individual or collective solutions based on their product portfolio and business models.

3.4.3

To date, Article 8 of the WEEE Directive obliges producers of electrical and electronic equipment to meet the costs of recycling their products at the end of their products' life. The EU established an individual producer responsibility (IPR) requirement through Article 8.2 of the WEEE Directive, whereby each producer is financially responsible for the recycling of waste from his own-brand products from private households, put on the market after 13 August 2005. The producer can choose to fulfil this obligation either individually or by joining a collective scheme.

3.4.4

At this moment, producers are investigating solutions. It could well be that in the near future producers may want to deal with this issue either in individual or collective systems.

3.4.5

The Committee shares the view that article 8.2 is the appropriate legal framework for the implementation of producer responsibility for WEEE.

3.4.6

The review of the Directive must be considered an opportunity to strengthen the freedom of choice between Individual Producer Responsibility and collective solutions.

16.12.2009   

EN

Official Journal of the European Union

C 306/42

1.1

Invasive species (‘IS’) are an increasing threat to biodiversity, agriculture and public health. At this moment, the estimated cost of IS is between 10 and 12 billion Euro a year, which also makes it a real threat to the economy.

1.2

The Committee acknowledges that there is a clear need for action, as also expressed at the highest political level, and takes note of the four policy options to tackle IS, as described in the Communication: ‘business as usual’, use of existing legal instruments together with voluntary measures, adapted existing legislation and the setting up of a comprehensive, dedicated EU legal instrument.

1.3

The Committee acknowledges that the document provides an excellent analysis, but at the same time notes that the Community should have responded already three years ago when the Biodiversity Action Plan was adopted, and therefore calls for immediate action.

1.4

The Committee is convinced that the best approach to tackle the threat of IS would be through the adoption of a comprehensive, dedicated EU legal instrument, as well as the establishment of a European Agency to monitor implementation.

1.5

The Committee emphasises the need to raise awareness among the EU public about the threat posed by IS due to rapidly growing trade and transport activities. This could be achieved through communication and education activities, highlighting the various threats and the economic cost of no/insufficient action.

1.6

The Committee deems it important that the social aspects of tackling IS are duly taken into account in the application of current EU rules or in a future comprehensive EU legal instrument, as illustrated by the significant health risks associated with the gasification of tankers upon their arrival in EU ports.

2.1.1

The term ‘Invasive Species’ used throughout this document encompasses the terms ‘Invasive Alien Species’ as found in the Convention on Biological Diversity and ‘Invasive non-native species’. Invasive Species are broadly defined as species whose introduction and/or spread may threaten biological diversity or have other unforeseen consequences. The European Commission states in its Communication that Invasive Species (IS) are becoming an increasing problem to the EU.

2.1.2

The DAISIE project, supported under the Sixth EU Research Framework Programme, has identified 10 882 non-native species present in Europe, 10 — 15 % of which are expected to have a negative economic or ecological impact. The main drivers directly affecting biodiversity are habitat change, climate change, over-exploitation, pollution and IS.

2.2.1

While EU instruments exist to deal with four out of those five factors, there is, in contrast to several other OECD countries, currently no comprehensive instrument at EU level to tackle IS. This shortcoming needs to be addressed if the EU is to attain its goal ‘to halt the decline of biodiversity by 2010’. In addition, IS also represent a major economic threat to the EU.

2.2.2

The need for coordinated action to tackle the IS issue has been expressed at the highest political level. The Environment Council, the European Parliament, the Committee of the Regions (1) and the European Economic and Social Committee (2) have all stressed the need for an EU strategy on IS and an effective early warning system and for effective response mechanisms at EU level. Similar commitments have been included in the Sixth Environmental Action Programme, as well as in the Communication from the Commission on Halting the Loss of Biodiversity by 2010 and Beyond and its associated Action Plan.

2.3.1

Invasive species (IS) may arrive and enter a new region through three broad mechanisms: importation as a commodity, introduction via a transport vector, and/or natural spread from a neighbouring region where the species is itself alien. These three mechanisms result in six principal pathways: release, escape, contaminant, stowaway, corridor and unaided.

2.3.2

Rapidly growing trade and transport activities expand the opportunities for IS introduction, and environmental pressures. The existence of the single market means that once an IS is introduced in the territory of one Member State, it can be dispersed rapidly throughout the EU. Therefore, addressing trade-related issues can only be done effectively at the EC's external frontier. Given the way that these species become established and spread, measures taken by one Member State can be totally negated, if neighbouring countries fail to take action or respond in an uncoordinated manner.

2.3.3

Rising CO2 concentrations, warmer temperatures, greater nitrogen deposition, altered disturbance regimes and increased habitat degradation are likely to facilitate further invasions.

6.2.1

The Commission writes in the Communication that halting the loss of biodiversity in the EU will not be possible without tackling IS in a comprehensive manner. The ecological, economic and social consequences of IS in the EU are significant and require a coordinated response. At present, the Community is unable to deal with IS efficiently and biodiversity-rich areas, e.g. EU overseas entities, do not receive appropriate attention. The existing EU legislation partially covering different aspects of IS makes coordinated implementation difficult. Policy consistency between most Member States is low or non-existent. Scientific scenarios point to a dramatic increase in biological invasions. Therefore it is likely that the situation will get worse.

6.2.2

The Committee is convinced that the best way to tackle the threat of IS would be through the adoption of a comprehensive, dedicated EU legal instrument as well as the establishment of a new European Agency to coordinate and execute the management of IS according to the three-stage hierarchical approach. That is the only way to ensure effective action, as is also stressed in the magazine Science. The estimated cost of such a European agency would be between EUR 4 and EUR 10 million a year, which is insignificant compared to the costs of the ecological, economic and sanitary impacts if the EU does not take action. A Commission initiative to stimulate EU-wide ratification of the Ballast Water Management Convention as quickly as possible would also be a major step forward in managing IS in an adequate way.

6.3.1

A new European legally binding instrument, as well as a new European Agency to execute new legislation, may meet resistance in several Member States for financial reasons. In their view, this type of measures should be paid for from the European budget, as it would be unreasonable to make the Member States with major ports and air hubs — by definition the places where most IS enter Europe — financially responsible for a policy the entire EU would profit from. Politicians in the Member States may see additional legislation and regulation to address an increasing biological invasion as a cost and therefore as an impediment to national economical growth, while taxpayers will most probably resist those extra costs, as they don't yet recognise the threats posed by IS. However this reluctance should not become an excuse for not taking action.

6.4.1

It is important to have an informed and engaged public in order to address IS issues effectively. At the moment, only 2 % of European citizens feel that biological invasions are important threats to biodiversity. Communication and education activities should build a sense of responsibility amongst European citizens, authorities and industries with regard to the potential threats of trade in and movement of potential IS. If these communication and education activities are not limited to the threat to biodiversity but also highlight the other dangers — to public health, to agriculture — people may become less reluctant towards new legislation and the establishment of a new European Agency, especially when it becomes clear that doing nothing will be much more expensive in the long term than acting now. And the sooner adequate action is taken, the lower the overall costs will be.

6.5.1

The EESC suggests that the Commission examines all existing tools and legislation to tackle IS and their harmful social side effects. The example of the gasification of containers that are shipped to Europe from other continents, to ensure that they arrive uncontaminated in European ports, illustrates these side-effects.

6.5.2

There are several ways to ensure that containers arrive uncontaminated in EU ports. However, the most common way is to gasify the containers with methyl bromide. Although that is the easiest and the cheapest way in the harbours where the containers are shipped from, it is at the same time the most complicated, as well as most expensive and most dangerous way in the harbours where the containers arrive.

6.5.3

Gasified containers need considerable time to degasify before they are safe to enter. However, as the entire economy is based on ‘just-in-time’ systems and containers have to be unloaded directly, there is often no time to degasify the containers properly. Due to this pressure, dock workers may enter the containers too early and without proper protection. Furthermore, gasified containers are often not labelled properly that they should be handled with care. To ship a gassed container is more expensive than to ship an un-gassed one, and in order to save costs many gassed containers are shipped without the prescribed label that they should be handled with care. In those cases, dock workers enter the containers without any protection to unload them directly after arrival. Since methyl bromide is not visible and has no smell, the poisonous gas can do its destructive work without the workers being aware of this. Consequently, an increasing number of dock workers have been contaminated with the very poisonous methyl bromide and disabled for the rest of their lives. As there are alternatives for treatment with methyl bromide, a ban on gasifying containers would fit well within a future framework of sustainable control measures for the early detection of IS.

16.12.2009   

EN

Official Journal of the European Union

C 306/46

1.1

The European Economic and Social Committee recognises the content and proposals contained in the Commission Communication COM(2008) 534 as beneficial for the development of marine and maritime scientific research in the EU and considers that the strategy for marine and maritime research outlined in the Communication represents an opportunity for achieving the objectives set out in the Communication.

1.2

The Committee endorses the main objectives of the new Strategy for Marine and Maritime Research, especially those which, when achieved, will help integrate the individual marine and maritime research centres and programmes which exist in the different Member States.

1.2.1

The Committee believes that one effective method for overcoming the lack of integration in the research sector is the development of an appropriate research infrastructure. The Committee notes that the broad outline for developing this infrastructure, set out in the Communication, serve to achieve this aim.

1.2.2

In the Committee's view, to increase the level of integration in the research field, the Member States should tailor their strategies to the European research objectives set out in the Communication. Equally, the EU institutions should account of any feedback received from the Member States.

1.3

The Committee draws attention to the importance of informing civil society of the results of marine and maritime research. Coastal communities are particularly interested in the results of marine and maritime research as they will have an ever-increasing impact on the development of these regions.

1.4

In the Committee's view, providing the various marine and maritime research centres in Europe with access to databases used for such research in the different countries of the EU is one aspect which can have a significant impact on the effective implementation of marine and maritime research strategies. Accordingly, the Committee believes that access to databases could be increased by the Commission's proposal to launch a European marine observation and data network (EMODnet).

1.5

The Committee views as priority research on regional and global ecosystems and how they relate to the issue of climate change and its impact.

1.6

The Committee considers the following four key regions to be core areas for European marine and maritime research:

1.7

The Committee wishes to highlight the importance of establishing a common set of comprehensive indicators (for each of the regions identified in Point 1.6), calculated on the basis of jointly used databases. This issue should be addressed in more detail by the Commission and the Council in the follow-up work to the Communication. The Committee believes it would be particularly useful to develop further the indicators describing the state of marine ecosystems and their evolution.

1.7.1

The indicators describing the state of the marine ecosystems will provide a basis for assessing the effectiveness of any action taken to ensure the protection and sustainable management of maritime resources and will enable the observation and evaluation of any changes occurring within marine ecosystems.

1.8

It is important to ensure the continuity of marine and maritime research work, and the new strategy should ensure this to a far greater extent. There have been several recent cases of important marine and maritime research projects being terminated.

1.9

It is vital to ensure that the research requested is relevant to the economic activity of both large businesses and SMEs. Equally, in this context, it is important to provide enterprises with better access to the results of such research, so that they can make use of it. This is why the process of informing stakeholders and coastal communities about the plans, scope and results of such research has such an important role to play.

1.10

It is also necessary to resolve the issue of those fields of marine and maritime scientific research which are not covered by the European Research Strategy and which, as a result, experience difficulties in securing funding for their projects. For this reason, a reference to supporting such research through dedicated Commission funds should be included in the documents drawn up as part of the follow-up work to this Communication.

1.11

The Committee believes that the Commission's future action in the field of marine and maritime research should focus more on the threats to the natural biodiversity of the Mediterranean, Baltic, North and Black Seas caused by the progressive loss of natural habitats for marine flora and fauna.

1.12

The Committee believes that promoting the creation and supporting the development of existing partnerships for marine and maritime research represents a key aspect of the strategy. Accordingly, the EESC endorses the Commission's plan to launch a new governance model for research that will take the form of a ‘Forum’ bringing together a ‘partnership sustainable over the long term’ and urges the Commission to draw up proposals in the short term to create a network of contacts between scientific communities involved in marine and maritime research, thereby helping to harmonise the process of creating partnerships.

1.12.1

In the Committee's view, the proposed ‘forum’ should, in addition to scientists, also encourage the participation of representatives of the various stakeholders involved along with marine and maritime policy-makers.

1.12.2

Further to the recently established European Fisheries Control Agency, it would be desirable to involve the agency in the work of the ‘forum.’ The Committee considers that the agency should play an important role within the ‘forum.’ Its opinion should also be sought when drawing up research plans, in its areas of competence.

1.12.3

The Committee encourages the Commission to set up the planned advisory mechanism for the two-way exchange of information between the scientific community and maritime policy-makers.

1.13

The Committee calls on the Commission to support the construction of oceanographic research vessels in the Member States in order to step up marine and maritime research, improve its quality and broaden the range of research topics covered. In the Committee's view, a decision should ideally be taken to establish a pan-European marine and maritime research facility.

1.14

Taking into account the existence, importance and the development of a regional infrastructure for marine and maritime research within the EU (1), the Committee, whilst recognising and endorsing the assistance to be provided in terms of regional needs mapping, as outlined in the Communication, calls on the Commission to consider developing links between ‘large’ (European and national) and ‘small’ (regional) research networks when defining the scope of these needs.

1.15

As a final remark on the conclusions and recommendations presented in the opinion, the Committee urges the Commission in its work on the follow-up to the communication, to assess the impact of marine and maritime research not only on the sustainable maritime economy, but also on sustainable development in general.

2.1

The European Strategy for Marine and Maritime Research presented in Commission Communication (2008) 534 constitutes an essential part of the action plan (2) accompanying the Communication on An Integrated Maritime Policy for the European Union  (3). The outlined strategy also represents a continuation of the Galway (4) and Aberdeen (5) declarations, two key maritime policy documents.

2.2

The strategy set out in the communication under consideration also puts into effect the EU Programme outlined in the Green Paper on The European Research Area: New Perspectives (6) and its specific recommendations contained in the Council Conclusions (7) on the launch of the ‘Ljubljana Process’ — ‘towards the full realisation of the European Research Area.’

2.2.1

In this context, the communication under discussion represents an example of a coherent European Research Area framework in support of a sustainable use of oceans and seas.

2.3

A number of EESC opinions in recent years have outlined the Committee's views on a series of Commission documents dealing with the EU's maritime policy in general and the European Research Area. These opinions did not focus more widely on the issue of European marine and maritime research largely due to the fact that the EU institutions had not put forward any documents which fully addressed the issue of marine and maritime-related scientific research.

2.3.1

Among the EESC opinions mentioned above, it is worth highlighting those in which the Committee called for more marine and maritime research in the fisheries sector (8).

3.1

Given the increasing scope of marine and maritime research in the European Union and its ever-greater role, it is essential to ensure the integration and coordination of such research.

3.2

The approach set out in the Communication represents an important opportunity to develop European marine and maritime research, in particular by:

3.3

The Communication's proposal to establish closer ties between existing European institutes specialised in the field of marine and maritime research, with the aim of eventually creating a European network of European sea and ocean research institutes, provides an important impetus for taking further joint action in the field of European marine and maritime research and may be considered to be an important step towards building the capacity of the EU's marine and maritime research sector.

3.4

The Communication refers to the activity of scientific research platforms, such as the ESFRI (9) or the principle of ensuring European support for marine and maritime research with a global dimension, which can help achieve the objectives of the EU's integrated maritime policy.

3.4.1

The Committee endorses the ESFRI initiative, which represents a significant opportunity for marine and maritime research communities across Europe. The ESFRI's activity should also be useful for a wide range of interest groups, including industry and small and medium-sized enterprises (SMEs) and regional science and research communities. Ensuring that SMEs have access to a common research infrastructure is a matter of considerable importance.

3.4.2

It is also vital to ensure close cooperation between scientists and sea/maritime resource users as well as between scientists and institutes which specialise in protecting the marine environment and NGOs.

3.5

As regards the issue of the integration of established marine and maritime research disciplines, as proposed in the communication, the implementation of the strategy outlined in the document should make use of the results of the cooperation between the EU Member States under initiatives such as ERA-NET and ERA-NET PLUS aimed at coordinating scientific research. These results will provide data and information on common EU research priorities and on those areas of research where the Member States are prepared to strengthen their cooperation.

3.5.1

One example of a marine and maritime research initiative involving the participation of all the countries bordering a European sea is the European Economic Interest Grouping which is preparing to implement a joint Baltic Sea research programme (BONUS) under Article 169 of the EC Treaty.

3.5.2

In the opinion of the Conference of Peripheral Maritime Regions of Europe (10), effective coordination should be ensured between initiatives aimed at integrating research activities, for instance through building networks of Poles of Excellence, as well as via initiatives aimed at integrating research funding programmes, for instance through Era-Nets.

3.5.3

The integration and coordination of marine and maritime research should provide easier access to information about the marine environment. It should also lead to savings as funding is often currently used to conduct identical or very similar research in several different research centres simultaneously.

3.6

The marine and maritime research strategy set out in the communication attaches a large degree of importance to ensuring that marine and maritime research funding under the 7th Research Framework Programme is used as leverage to promote a synergy effect between Member States’ research efforts and, where necessary, reach a critical mass to address major cross-thematic marine research challenges.

3.6.1

Given the need to achieve synergies between research activities, it is vital that future scientific research focus on, among other things, the sustainable support, collection and management of data on the seas

3.6.2

It is important to ensure that action aimed at achieving synergies between research projects takes account of the various regional approaches. In the opinion of the Conference of Peripheral Maritime Regions of Europe (11), the regions support the objective of a better coordination of marine and maritime research programmes in Europe, an aim which is pursued, for example, by the Era-Net scheme, and, in future, by the joint programming.

3.6.3

However, as highlighted in the CPMR documents, projects funded under Era-Net have so far rarely involved regions. It would therefore be useful to either set up new funding schemes to coordinate regional research programmes that do not have a sufficient critical mass to integrate major Era-Net projects or to establish conditions of coordination between regional authorities and stakeholders involved within Era-Nets. Such coordination should also ideally be organised on the basis of maritime basins.

3.6.4

Coordination between Structural Funds, the Framework Programme and other European funding sources is also a key objective. Such coordination can only result from a coherent use of European funding sources by beneficiaries such as researchers and SMEs and of a coherent programming of funds in which the regional level plays a crucial role.

3.7

The strategy outlined in the communication recommends the design of an effective and innovative research governance framework that engages scientists, policy-makers and the public, so as to achieve shared understanding and informed decision-making based on sound scientific knowledge.

3.7.1

This approach to governance in research should be viewed in a positive light. The Commission has made it possible for Member State governments to establish a new framework for marine and maritime research involving scientists, industry representatives and public authorities, an opportunity which should be seen as a step in the right direction.

3.7.2

Given the role which the regions play in supporting maritime transport and research, they should be considered — along with the regional economic and social councils which are also often active at local level — as partners in the proposed system of governance for marine and maritime research.

4.1

The Committee believes that the list of major research topics requiring a cross-thematic approach outlined in Box 2 should be supplemented as follows:

4.2

The Committee urges the Commission to refer directly to the list of examples of pan-European research infrastructure projects, as identified by ESFRI, and which may be developed during FP7 (2007-2013), in the documents drawn up on the basis of the Communication when discussing and assessing progress on building new observation and research infrastructure.

4.2.1

The following projects on the list are in the field of marine and maritime scientific research:

4.3

The Committee believes there is a need to pay special attention to focusing support on building more oceanographic research vessels, which represent the principal marine and maritime research tool.

4.3.1

While the coordination and research activities conducted by research institutes are very important, oceanographic research vessels are needed if we are to investigate what is taking place further away from the shoreline. Sadly, however, Europe has only a modest fleet of research vessels. If it is to carry out comprehensive and effective marine and maritime research, the EU must above all have appropriate research vessels at its disposal.

4.4

On the issue of developing new models for higher education in the marine/maritime field, as raised in the Communication, the EESC notes one field of studies where synergies have been achieved and which merits consideration when identifying examples of educational innovation is sozology. This university discipline covers the nature-based, technical, economic and legal aspects inherent in the modern approach to sustainable development, and therefore dovetails with the contemporary approach to the maritime economy.

4.5

Considering that one of the Communication's main objectives is to achieve synergies in the field of European marine and maritime research, the EESC believes that it is possible to ensure the closer integration of research and, accordingly, increased synergies through the adoption of a comprehensive approach to the field of research in question.

4.5.1

One example of such activity is the synergy-based approach to coastal area research covering both the effects of climate change (e.g. rising sea levels) and geological events, as well as recreational opportunities etc. (necessary cooperation in the environmental, technical, economic and legal fields).

4.6

In order to achieve synergies in the area of marine and maritime research, the Committee believes that it would be appropriate to create a three-level system (organisational pyramid) to manage the finances allocated to research projects. The following core areas (regions) would represent the foundation of this structure:

4.6.1

A regional or inter-regional structural management centre should be set up to coordinate all action taken to share information and create inter-disciplinary research objectives, which integrate the research policies of the countries located in (or bordering on) the above four regions, drawing on the experience and marine/maritime scientific/research infrastructure of these four core regions.

4.6.2

The central coordination system located in the European Research Area, which would also act as an information centre on research funding, would constitute the highest level of this organisational structure.

4.7

A regional approach is necessary given the individual environmental and natural specificities of the various sea basins. While they share many characteristics common to the entire marine environment, the natural events and processes underway in these areas are different in nature and in the way they run their course. This is the case for instance, when we compare what is taking place in the Baltic Sea region with the situation in warmer seas e.g. the Mediterranean or Black Seas, or the Atlantic coast whose tides are a characteristic feature.

4.8

There is an urgent need to set-up ‘associations’ within these specific regions, using the existing infrastructure as a basis. Examples would be a Baltic association of research stations, research vessels, research institutes or higher education institutes.

4.8.1

The aim of these associations should be to share information on research and educational tasks being carried out and to carry out joint agreed research and educational projects.

4.9

One important field of marine and maritime research which has achieved clear synergies is research into eutrophication and its effects. While it is a worldwide phenomenon, some of its causes and effects may differ in each of the proposed regions (basins), confirming the need to adopt a regional approach. Equally, however, there is scope for clear synergies considering the causes of the phenomenon, research methods and impact analysis, particularly economic analysis, as well as the related medical/epidemiological aspects.