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A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient
This communication is the Commission's response to the recommendations made by the "G10 Medicines Group" or the High Level Group on Innovation and the Provision of Medicines in its final report. With this document, the Commission wishes to foster further discussion at European level on promoting an integrated market for medicines, strengthening the competitiveness of the pharmaceutical industry and controlling healthcare expenditure.
Communication from the Commission of 1 July 2003 on strengthening the European pharmaceutical industry for the benefit of the patient. [COM(2003) 383 final - Not published in the Official Journal].
The "G10 Medicines Group" was set up in 2001 on the initiative of the Members of the European Commission responsible for the "Enterprise" and "Health and Consumer Protection" Directorates-General. Alongside the two Commission representatives, it is made up of ten experts recruited from the industry, national Ministries of Health, social security organisations and patients groups.
This focus group was asked to recommend ways of improving the performance of the pharmaceutical industry in terms of its competitiveness and its contribution to social and public health objectives.
In accordance with the objectives it was set, the G10 group submitted its final report to the Commission in May 2002.
This contains a set of 14 recommendations prompted by two considerations:
- the pharmaceutical industry in Europe generates wealth and high quality employment whilst playing a central role in the development of innovation. It can thus make a major contribution to achieving the goals set in Lisbon (a competitive knowledge-based economy, sustainable economic growth, and more and better jobs);
- the pharmaceutical sector is lagging behind the USA in its ability to generate, organise and sustain innovative processes. In addition, European markets are not competitive enough and R&D expenditure is not growing fast enough.
Faced with this situation, the G10 group pointed out that tackling the growing weaknesses in the EU pharmaceutical industry is both a major industrial policy concern and a key public health objective (to improve the quality, safety and efficacy of medicines for the benefit of the public).
In this communication, the Commission states how it wishes to implement these recommendations and proposes certain actions the Member States could take on matters of national competence.
WORKING FOR THE BENEFIT OF THE PATIENT
Improving patient information
With the steady growth in the demand and use of health information by patients, the information sources on offer (particularly on the Internet) are proliferating. Faced with this new situation, the Commission seeks to improve the quality and reliability of this information and provide a realistic and practical framework to give patients access to objective data.
Following on from its communication in 2002 entitled "Quality criteria for health-related websites", the Commission proposes looking into the possible development of European seals of approval for such sites.
In addition, as part of the new Public Health Programme (2003-2008), a European Health Portal is being developed which should allow this information to be disseminated to the general public.
To increase public confidence in the information on medicines, the Commission will reflect on establishing a collaborative Public Private Partnership involving representatives from public authorities, industry, health funds, healthcare professionals and patient groups. This partnership could take the form of a small body that would be able to advise and monitor the quality of the information already available. It would also produce guidelines in specific areas to support the work of National and Community regulatory authorities.
Finally, the Commission would like to ensure that patients consume medicines appropriately. To do so, it wishes to ensure that the information contained in the patient information leaflet and on the label (dosage, contra-indications, special precautions for use) are as comprehensible and legible as possible.
Strengthening the role of patients in public-health decision-making
Also under the Public Health Programme (2003-2008), the Commission plans to make funds available to patient groups looking to create a Community umbrella organisation. The Commission would also like these groups to assume a more important role in the development of Community health and medicines policy.
The concept of the relative effectiveness of medicines
The Commission wants to set up a forum where Member States which use relative effectiveness measures to set prices and reimbursement levels for medicines could exchange information on their methods. This would make it possible to analyse whether, on the basis of the national approaches used to calculate the relative effectiveness of a medicine, i.e. the assessment of added therapeutic value (its clinical effectiveness compared to other treatments) and its cost effectiveness, an effective and faster common procedure could be introduced.
Improving pharmacovigilance systems
The Commission wishes to strengthen pharmacovigilance at Community level through the role of the European Medicines Agency (EMEA) which should help coordinate national action and centralise results. The ultimate aim is to enable Member States to benefit from more information about adverse reactions to the use by the general population of a medicine which has previously only been tested during clinical trials.
DEVELOPING THE INDUSTRY'S COMPETITIVENESS
Updating the regulatory structure
In order to improve marketing authorisation procedures, the Commission points out that it would be desirable to shorten dossier assessment times and make greater use, under the centralised procedure, of telematics through EudraNET, the EuroPHARM Database and EudraVigilance.
Access to innovative medicines
The development of innovative medicines with a high added therapeutic value should be encouraged under the 6th Framework Programme for Research.
In addition the Commission, through its proposal for a review of pharmaceutical legislation, has demonstrated its desire to support research into innovative medicines and provide sufficient protection for the exclusivity of the data on such medicines.
The timing of reimbursement and pricing negotiations
The Member States should examine their existing pricing and reimbursement systems to ensure that they operate fully in accordance with the transparency requirements and within the timeframe set by Directive 89/105/EEC (pricing of medicinal products and health insurance systems).
The Commission and Member States should examine the scope for reducing the time taken between granting a marketing authorisation and pricing and reimbursement decisions to the absolute minimum.
For the time being, the prices of medicines are widely divergent amongst Member States as they are set by national administrative decisions. To facilitate market integration, the Commission suggests giving manufacturers the possibility of setting the prices of medicinal products, while negotiating with the Member States the possibility of introducing safeguard mechanisms to contain pharmaceutical expenditure by the State. Such a system is intended to open the way for the free fixing of prices of medicines on the market, as with any other product in the internal market.
Medicines not reimbursed by the State
The Commission asks the Member States to remove price controls on manufacturers that prevent full competition for medicines that are not reimbursed by the State and for those which are not to be sold to the public sector.
The competitive generic medicines market
Generic medicines can provide significant savings to patients and to national healthcare financing systems, which is why the Commission stresses the need to facilitate generic penetration in the different national markets.
In order to put this into effect, the Commission points out that generic producers should be given the opportunity to supply generic medicines to Member States where the reference product is not on their market.
This communication also points out that, as part of the reform of the Community code relating to medicinal products for human use, the Council's common position suggests the possibility of introducing a marketing authorisation application for a generic and to grant this authorisation in the last two years of the data protection period of the reference product for all products except those falling within the mandatory scope of the centralised procedure. This will allow these products to come onto the market immediately after the end of the ten-year data protection period.
The competitive non-prescription market
To reduce the differences amongst Member States in products classified as non-prescription, the Commission suggests that there be greater consistency in classification decisions.
Moreover, since the reclassification of medicines from prescription to non-prescription status brings benefits to patients, healthcare professionals, governments, healthcare systems and industry alike, the Commission suggests the introduction of a period of data exclusivity where significant clinical or pre-clinical data have been submitted with the application.
Finally, the Commission advocates that the Member States allow the use of the same trademark after reclassification where there is no risk to public health, as this avoids financial costs which may dissuade producers from taking this step.
STRENGTHENING THE SCIENCE BASE
The fragmented nature of European research systems (lack of scientific collaboration among Member States and between the public and private sectors) is hampering R&D activity in the EU and the introduction of innovative processes.
The Commission suggests a very broad range of measures to remedy these problems:
- taking forward the concept of European virtual institutes of health;
- creating a genuine European research area as set out in the sixth framework programme for research (scientific cooperation and training to stem the loss of highly-skilled European scientists);
- an increase in Community research spending to 3% of GDP in the EU by 2010 in line with the strategy agreed at the Barcelona European Council in March 2002;
- the implementation of a life science and biotechnology action plan (skilled workforce, financial support, networking of biotechnology regions in Europe, developing the size of enterprises in the sector);
- the creation of a European Centre for Disease Prevention and Control which should become operational no later than 2005;
- the development of proposals to encourage R&D on diseases which are currently neglected or where R&D is lacking.
The incentives for research which the Commission wishes to introduce also include:
- the creation of a database on clinical trials and the drafting of detailed guidelines on the principles of good clinical practice as defined in directive 2001/20/EC;
- the promotion of research into orphan medicines by taking measures on rare diseases;
- finalisation of the proposal for a regulation on medicines for paediatric use which is expected in 2004;
- the rapid implementation by all Member States of the Directive on Legal Protection of Biological Inventions and the adoption of the Community patent legislation.
MEDICINES IN AN ENLARGED EUROPEAN UNION
The health status in the future Member States is generally lower than in the rest of the EU and they devote fewer resources to healthcare. Also, the levels of intellectual property protection differ, leading to divergences in price levels, which could cause an increase in parallel imports.
For a limited period after accession, some medicines on the market in the new Member States will not have the same level of intellectual property protection found in the existing Member States. The Accession Treaties were, therefore, amended to include a transitional period prior to the full application of the principle of free movement to prevent the parallel import of pharmaceutical products that lack equivalent intellectual property right protection.
In addition, under the pharmaceutical legislation review, there will be a statutory requirement for parallel importers to inform both the marketing authorisation holder and the competent authorities of their intention to proceed with a parallel import in a given Member State. However, the legal responsibility for enforcing intellectual property rights will remain with the patent holder.
The pharmaceutical legislation review will also allow generic supply of medicines in Member States where there is no reference product on the market, and help to alleviate problems of availability in the new Member States.
Alongside these different measures, the new Member States have been offered practical help to prepare for accession through the Pan European Regulatory Forum (PERF).
THE EXCHANGE OF INFORMATION AMONG MEMBER STATES
In its final report, the G10 Medicines Group recommends the development of a set of EU indicators to cover both industry competitiveness and public health objectives. Benchmarking is no solution to the problems of competitiveness in itself but it will, for the first time, establish a set of agreed EU performance indicators that will provide a comprehensive and objective basis for measuring the implementation of the recommendations and to exchange best practice.
The competitiveness indicators cover four broad areas: supply, demand and the regulatory framework, industry outputs, and macroeconomic factors. The Commission will publish annual tables of competitiveness indicators. This data will thus provide a basis for discussion in the Council, the European Parliament and at International Conferences.
Developing a set of indicators that can monitor the role of the pharmaceutical industry in preventing and treating disease is no easy task. While industry has clearly made a key contribution to public health in a number of areas, it is difficult to quantify in global terms and in terms of individual products or for specific diseases. The Commission is working on the development of a range of indicators in this field which should cover:
- the availability of pharmaceutical products, compared to other health care inputs, for priority diseases;
- the significance of available medicines, e.g. in terms of their effectiveness;
- the identification of those diseases for which there are no effective medicines;
- the prescription and rational use, at the medical professional and patient level;
- patient quality issues such as the acceptability of medicines.
The Commission undertakes to update and adapt these performance indicators annually and to submit them to the Council and the European Parliament at regular intervals. It also plans to set up a small secretariat to take forward the benchmarking exercise.
Maintaining the momentum of G10
The Commission would like Member States, on a voluntary basis, to communicate national measures that could have an impact on G10 Medicines-related issues.
The Commission invites the Council and the European Parliament, together with other stakeholders, to take forward the key actions highlighted in this Communication
The Commission will support the organisation of annual meetings to follow up this Communication and to verify progress on key actions.