EU must act against counterfeit medicines

2.42.03pm BST (GMT +0100) Fri 8th Sep 2006

Baroness Sarah Ludford MEP is backing European Parliament calls for the EU to take stronger action on counterfeit medicines. MEPs have passed a resolution, initiated by the European Liberal Democrat group, in their session in Strasbourg.

In developing countries, the most widely counterfeited medicines are those used to treat life-threatening conditions such as HIV/AIDS, tuberculosis and malaria. However, this phenomenon does not just affect developing countries; for instance early 2006, UK authorities seized 5000 packets of counterfeit flu medicine 'Tamiflu' with an estimated worth of £500,000.

Sarah Ludford said:

"This is not just a business issue about corporate profits. Counterfeiting medicines is a shameful practice, preying on the most vulnerable people in society. The impact is devastating and tragic; these products are either useless in lacking the necessary active ingredients, or dangerous in leading to drug resistance or even death."

"But this lucrative criminality is growing at an alarming rate. Counterfeit drug sales are predicted to reach $75 billion globally in 2010 - an increase of more than 90% from 2005.

"It is essential that the EU uses its political and economic weight to help poor countries regulate medical products, to combat counterfeiting within Europe and to promote international cooperation on this issue."

Notes:

The resolution passed by MEPs reads:

The European Parliament ,

• having regard to the statement on the fight against counterfeiting by the Heads of State and Government of the G8 at the St Petersburg Summit on 15, 16 and 17 July 2006,

• having regard to the Declaration of Rome adopted at the WHO international conference of 18 February 2006,

• having regard to the Commission's initiatives on enforcing intellectual property rights and its action plan against counterfeiting and piracy adopted in October 2005,

• having regard to the judgment of the Court of Justice of the European Communities of 13 September 2005 (C-176/03) which has strengthened the European Community's capacity to impose penal sanctions for counterfeiting,

• having regard to the WHO resolution on "public health, innovation, essential health research and intellectual property rights" adopted on 29 May 2006,

• having regard to Rule 108(5) of its Rules of Procedure,

A. whereas the counterfeiting of medicines can have extremely serious consequences and may well endanger the health and life of millions of people,

B. whereas, according to the WHO, "a counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging",

C. whereas counterfeit medicines are primarily circulating in developing countries and are used to treat fatal conditions such as malaria, tuberculosis and HIV/AIDS,

D. whereas the WHO estimates that the counterfeiting of medicines now affects 10% of the world market, and whereas the US Food and Drug Administration puts the figure at more than 10%; whereas up to 70% of anti-malaria drugs circulating in Cameroon are counterfeit, a figure confirmed for six other African countries by the WHO in 2003; whereas 25% of all medicines used in developing countries are apparently counterfeit (50% in Pakistan and Nigeria),

E. whereas, according to the WHO, 200 000 of the one million deaths a year from malaria are attributable to medicines wrongly administered or the administration of counterfeit medicines,

F. whereas the counterfeiting of medicines is rife in all continents but mainly in Africa, Asia, Latin America and Russia,

G. whereas the most common factors identified by the WHO as encouraging the appearance of counterfeit medicines are: the lack of legislation prohibiting counterfeiting of medicines, weak penal sanctions, weak or non-existent national drug regulatory authorities, shortages/erratic supply of medicines, lack of control of drugs for export, trade involving several intermediaries, corruption and conflict of interest,

H. whereas this trafficking in fake medicines is also a consequence of the lack of political awareness and commitment, weak regulatory systems, inadequate enforcement capacity and, especially in developing countries, the lack of public access to genuine medicines supervised by the public authorities,

I. regretting that the European Union became involved only at a late stage in the international fight against counterfeiting, when more open borders and new technologies (Internet) were likely to exacerbate the problem of piracy,

1. Considers that the European Union should equip itself as a matter of urgency with the means to combat effectively illicit practices in the area of piracy and the counterfeiting of medicines;

2. Calls on the Commission to go beyond its communication "Strategy to enforce intellectual property rights in third countries"; in particular, urges the European Union to take adequate measures to combat the scourge of counterfeiting of medicines in its territory;

3. Calls on the European Union to take steps to strengthen the regulatory and quality-control capacity for medicinal products and medical equipment put on the market in countries with inadequate resources and to improve access to affordable medicines;

4. Urges the European Union to play a key role in promoting an international convention to create a specific criminal offence of counterfeiting or the receiving and distribution of counterfeit medicines in the legislation of every country;

5. Calls for greater cooperation at both national and international level between the various authorities involved in anti-counterfeiting measures;

6. Emphasises the importance of preventive measures in action programmes, more specifically, the establishment of structures, cooperation, awareness campaigns, preferably carried out by the public authorities, and finally the political will to carry through such measures successfully;

7. Instructs its President to forward this resolution to the Council, the Commission, the governments of the Member States, the UN Secretary-General and the Secretary-General of the WHO.