Doc. 10492

7 April 2005

The quality of medicines in Europe

Motion for a recommendation

presented by Mr Marquet and others

1.       Protecting public health and guaranteeing the quality of medicines by requiring that they comply with optimal standards for efficacy and safety must be given a high priority by the member states of the Council of Europe.

2.       This public health mission has increasingly been made more difficult by a variety of factors: globalisation of supply of raw materials used to manufacture medicines and also of medicines provided as "finished products", the new possibility of obtaining "finished" medicines through the Internet. Other factors include price wars, the cost of international research which raises the price of innovative drugs, budgetary constraints on states faced with spiralling health costs and which often are unable to invest in control structures that are appropriate for this new international era and for the latest technology.

3.       When combined, these factors can lead to inequalities between European citizens as regards the quality of medicines on the national markets.

4.       The "quality" aspect of medicines may suffer due to inadequate criteria for production quality with risks of cross-contamination and substandard products and of higher levels of hazardous residual solvents and impurities of synthesis.

5.       In this context, counterfeit medicines are a growing concern. According to WHO, 5 to 8% of medicines in the world are counterfeit.

6.       South America and West Africa were the first regions to be targeted, with the proportion of counterfeit medicines reaching 40% and 70% of the market, respectively; the next target for organised crime is Europe. The market for counterfeit medicines is highly lucrative, with profits of $400 billion per year and an annual growth rate of 7%. All types of medicines and all pharmaceutical manufacturers are concerned.

7.       At present, more than 100 national laboratories from over 40 countries are participating in the European network of official medicines control laboratories. Their efforts are important to facilitate mutual recognition of medicinal quality control from one country to another and to promote access by patients to pharmaceutical products of the same quality.

8.       It is therefore essential for all states to have access to the same quality references for medicines to reduce public health risks and ensure the safety of health products in Europe.

9.       Given the extent of public health risks in Europe, it appears to be necessary to take the necessary measures at the international level so that means of prevention and action can be co-ordinated and appropriate networks can be set up.

10.       In this context, the Council of Europe has an instrument, the Convention on the Elaboration of a European Pharmacopoeia which was signed in 1964 and which is a partial agreement of the Council of Europe, as well as the European network of official medicines control laboratories set up in 1994. At present, 34 member states of the Council of Europe, including all of the countries of the European Union, have ratified the Convention and 4 member states have observer status. Faced with the global movement of products, the European Pharmacopoeia has seen fit to develop its activities in a partnership with other non-European countries.

11.       The European Pharmacopoeia is at the same time an instrument for public health, a standardisation work and the reference and model for quality in the area of medicines.

12.       Consequently, the Assembly recommends to the Committee of Ministers that they urge member states of the Council of Europe that have not yet done so to sign and ratify the Convention on the Elaboration of a European Pharmacopoeia.

13.       The Assembly also asks the Committee of Ministers to recommend the following to states that are parties to the Partial Agreement and to observer states:

- to elaborate common standards for the quality of medicines to allow member states to have access to the same quality references and to reduce risks to public health and ensure the safety of health products in Europe;

- to draft a recommendation for member states that contains a catalogue of the measures required to reinforce training, information sharing and technical skills in official medicines control laboratories.

Signed ¹:

MARQUET, Bernard, Monaco, LDR

BARGHOLTZ, Helena, Sweden, LDR

CLIVETI, Minodora, Romania, SOC

CORTÉS, Luis Eduardo, Spain, EPP/CD

COX, Thomas, United Kingdom, SOC

EKER, Mehdi, Turkey, EPP/CD

EVIN, Claude, France, SOC

GLĂVAN, Stefan, Romania, NR

GÜLÇIÇEK, Ali Riza, Turkey, SOC

HANCOCK, Michael, United Kingdom, LDR

İNCEKARA, Halide, Turkey, EPP/CD

KOLESNIKOV, Victor, Russia, EDG

MARKOWSKI, Tomasz, Poland, EPP/CD

OSKINA, Vera, Russia, EDG

POL, Marek, Poland, SOC

PREDA, Cezar Florin, Romania, SOC

van WINSEN, Bart, Netherlands, EPP/CD

VERMOT-MANGOLD, Ruth-Gaby, Switzerland, SOC

VIS, Rudolf, United Kingdom, SOC

¹        SOC: Socialist Group

      EPP/CD: Group of the European People’s Party

      LDR : Liberal, Democratic and Reformers’ Group

      EDG: European Democratic Group

      UEL: Group of the Unified European Left

      NR: not registered in a group