A renewed vision for the pharmaceutical sector

The pharmaceutical sector must adapt in order to take advantage of globalisation and innovations in the field of science. In this perspective, it is important to define the outlines of an effective Community framework with a view to making progress towards the single market, taking on the opportunities associated with globalisation and enabling access to medicines for European patients.

ACT

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 21 December 2008 - ‘Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector’ [COM(2008) 666 final – Not published in the Official Journal].

SUMMARY

This Communication lays down objectives relating to the future of the pharmaceutical sector.

The new regulatory framework should contribute to reinforcing the safety of pharmaceuticals, encouraging innovation and making medicines more accessible for European patients.

Making progress towards a single market in pharmaceuticals

Better access to medicines

European patients should be able to benefit from scientific progress and obtain the medicines that they need for therapeutic purposes. Two options have been envisaged:

• to put the emphasis on smaller markets thanks to cooperation with Member States up to 2010;
• to identify, by 2010, ways to optimise the functioning of the network of European Union medicines authorities.

Transparency and the exchange of information in the field of pricing and reimbursement should be improved.

Better regulation for a more competitive industry

Regulation should be improved, particularly in the field of clinical trials. The first step towards improving regulation should be an assessment of the application of Directive 2001/20/EC on clinical trials by 2010.

Safer medicines for better informed citizens

The safety of medicines should be reinforced by the legislative proposal on pharmacovigilance. In parallel, it is important to provide the patients who request it with reliable and objective information on the medicines to which they have access.

The environment issue also comes into play via the proposing of measures aimed at reducing the negative effects of pharmaceuticals on the environment and public health.

Taking on the opportunities and challenges of globalisation

Tackling worldwide health challenges

To combat the circulation of illegal medicines, it is necessary to reinforce the exchange of information at international level by 2012 and to help third countries to take appropriate measures.

In the area of pandemics, bilateral and multilateral relations should be strengthened.

Global cooperation and harmonisation

Inspection mechanisms with the United States, Japan and Canada should be established by 2010. In addition, bilateral cooperation with Russia, India and China should be extended.

International harmonisation is advocated, particularly by means of the International Conference on Harmonisation (ICH). It is also recommended that the areas of the Transatlantic Economic Council (TEC) be used for the simplification and convergence of rules between the United States and the European Union.

Finally, for the European Union to be internationally competitive, the Communication encourages it to implement and enforce the framework of the World Trade Organisation (WTO), as well as the Free Trade Agreements (FTAs) in particular as regards the protection of intellectual property rights.

Making science deliver for European patients

Supporting pharmaceutical research

The Innovative Medicines Initiative (IMI) is to accelerate medicine development so as to make new treatment options available to patients earlier.

New horizons in medicine

These new horizons include two main challenges:

• advanced therapies such as regenerative medicine should be reevaluated by 2012;
• new technologies such as pharmacogenomics which make it possible to offer patients personalised treatment.

Background

At the beginning of the 21st century, Europe is facing challenges such as pharmaceutical innovation, shortcomings in the availability of medicines, the increasing globalisation of the sector and scientific breakthroughs.

It therefore appears important to shape a Community framework which allows continued progress toward a single and sustainable market in pharmaceuticals to be made, advantage to be taken of the opportunities and challenges associated with globalisation, and European patients to benefit from scientific progress.

See also

For additional information, please consult the following websites:

• International Conference on Harmonisation
• Transatlantic Economic Council
• Trade-related aspects of intellectual property rights

Last updated: 11.02.2009