Striking the right balance between competitiveness and public health across the EU

Date: 25/07/02

Erkki Liikanen, the EU's enterprise and information society commissioner, spells out his plans for the future of the pharmaceutical industry - a sector that's currently undergoing fundamental changes.

THE pharmaceuticals sector is of the highest interest and significance both from the point of view of public health and of industrial policy.

Currently, this sector is undergoing important changes.

In Europe, among the major challenges is the maintainance of the high level of public health protection we have achieved.

Our citizens expect to have access to the latest generation of medicines as quickly and as safely as possible.

We also need to further contribute to the completion of the internal market in the sector of medicinal products.

It is also important that we improve the competitiveness of the European-based pharmaceutical industry.

Only with a highly competitive and dynamic knowledge-based economy can we stimulate innovation and take full advantage of rapid scientific progress.

Finally, we need to prepare the European Union for the biggest enlargement it has ever experienced.

These challenges are too complex to be met by a single initiative. That is why the European Commission has adopted diverse approaches which represent different policy-developing and regulatory techniques.

With regard to medicinal products in general, we have already had a well-functioning regulatory framework in place since 1995. But we wish to further develop this framework in order to react to the challenges of public health, competitiveness and enlargement.

After an assessment by external consultants, the Commission drafted a comprehensive report in which we consulted member states as well as other stakeholders before adopting the final proposals for the review of the current pharmaceutical legislation in Europe.

For paediatric medicines, we do not have a specific regulatory scheme in place yet.

To meet the need for better paediatric medicines, we therefore launched a general consultation via the internet.

This set out possible options to improve the situation regarding paediatric medicines. Once we have analysed all contributions, we will decide what legislative measures to propose.

To look at more general issues of the competitiveness of the European-based pharmaceutical industry - in the context of broader public health and social goals - we chose another approach.

Together with Health and Consumer Protection Commissioner David Byrne, I set up the G10 Medicines Group.

This group consists of decision-makers in government, industry and mutual health funds, as well as a patient representative. We created this structure to explore ways to regain the competitive edge we have lost to the United States in recent years.

The Commission's role was to facilitate rather than to lead this process. The key objective of the G10 is to focus on the practical rather than the legislative.

On 7 May this year, the group handed the final report to President Romano Prodi. It set out 14 recommendations to improve the competitiveness of the European-based pharmaceutical industry in line with achieving EU public health and social objectives.

One of the most important recommendations concerns the creation of a benchmarking exercise. At the heart of this is the selection of agreed performance indicators that will enable us to disseminate best practice.

At the same time, it will help us to assess effectively the impact of EU and national measures in competitiveness, health outcomes and other areas.

We have never developed agreed performance indicators on a European scale before in this sector. Achieving this has been a significant step and will enable proper assessment of the implementation of the group's other recommendations.

With each of these approaches and initiatives, the Commission tries to strike a balance between the underlying political objectives regarding public health, enterprise policy and preparations for the forthcoming enlargement.

I will use the ongoing review of the legislation proposed in the summer of 2001 as an example of what this means in concrete terms.

Regarding the balance between the so-called 'centralised' and 'decentralised' member states' systems of authorising new drugs - the evaluation of the existing authorisation procedures has shown that, in general, the system in place since 1995 works well and has contributed to achieving a high level of public health protection in Europe.

The centralised procedure has proven its effectiveness for biotechnology and innovative medicinal products.

On the other hand, the decentralised - or mutual recognition - procedure offers an interesting alternative for those medicinal products intended only for a restricted part of the European market.

As a consequence, there is no need to fundamentally change the current system with its dual structure.

The objective of the proposed review is therefore focused on optimisation of the present procedures, while keeping their general structure.

The establishment of the European Agency for the Evaluation of Medicinal Products (EMEA) in 1995 and the setting up of a centralised European procedure for the authorisation of pharmaceuticals has been generally applauded as a success.

We are, therefore, recommending that more products should benefit from the centralised procedure. We believe this would benefit European innovative products.

Moreover, the centralised procedure will be open, on an optional basis, to any other product representing a significant innovation and to generic medicinal products.

Also, we want to increase the availability of new and innovative medicines on the European market, while at the same time ensuring the basic criteria of quality, safety and efficacy continue to be met.

We aim to do this in the following ways: first, we proposed a number of improvements, such as accelerating the different steps of both the centralised and the mutual recognition procedure.

Second, we have proposed a 'fast-track' registration procedure for products of significant therapeutic interest allowing these products to be assessed in an expeditious way. The idea underlying this procedure is similar to one that has been in place in the US for a number of years now.

The proposed review also foresees a conditional marketing authorisation.

This will allow the authorisation of new medicines on the basis of sufficient, but not definitive scientific data.

Finally, we are promoting a European-wide system for the availability of medicinal products in advance of authorisation on a 'compassionate use' basis.

Regarding the issue of providing better information, patients obviously have a right to know more about available medicinal products and why they have been authorised.

We are, therefore, proposing a number of measures to increase the transparency of the authorisation processes - and the information available on the internet in particular.

The proposals foresee an increase in the information available to the public in all stages of a product's life cycle.

The patient will have access to the scientific assessment of the application for a new product.

Still with the patient in mind, we are also proposing to introduce a new system aimed at ensuring the availability of better, patient-orientated and valid information on authorised pharmaceuticals.

What we want to achieve, as a test case, with respect to three specific disease groups (AIDS, diabetes and asthma), is to make sure that validated and patient-orientated information can be made available - when this information is needed by patients or groups of patients.

I would emphasise that the current ban on advertising of prescription medicines in Europe means that patients looking for information about their diseases and medicines are forced to rely on information produced by non-European companies on, for example, on their websites.

We are definitively not looking to introduce a US-like situation in which non-solicited advertising of prescription drugs to consumers is allowed.

Our proposal would allow patients to receive information, upon their request, on the medicines in question.

It also requires industry to follow principles of good conduct, as well as adopting a set of self-regulatory control procedures in agreement with regulatory authorities.

We consider the EMEA is best-suited to provide the high standard of services needed for the creation of this new mechanism. We must not forget that the pharmaceutical industry is the source of the majority of the innovative advances in medicines.

To ensure sufficient incentives for developing innovative medicines, the Commission proposes to harmonise the so-called 'data protection period' at ten years for all medicinal products.

This would mean that no generic spin-off of a centrally or nationally authorised product could come on to the market before that time, thus giving more opportunity for the innovative pharmaceutical industry to recoup its investments.

We are also suggesting, under certain conditions, an extra year of data protection for important new indications of existing medicinal products.

At the same time, we have not forgotten the need to support the European generics industry because we recognise the need to promote fair competition in the pharmaceutical sector.

We consider that the proposed new legislation provides for an optimal balance between innovative and generic medicines.

In conclusion, the proposed review of the pharmaceutical legislation, the paediatric initiative and the G10 medicines group, contains concrete European measures designed to tackle concrete European problems and challenges.

The different approaches chosen to generate ideas and proposals have worked very successfully.

Together they will contribute to the building of a firm framework for future action at both an EU and member state level in this area.

Major feature. The EU's enterprise and information society commissioner spells out his plans for the future of the pharmaceutical industry - a sector that's currently undergoing fundamental changes. Article is part of a European Voice survey on Pharmaceuticals.