MOTION FOR A RESOLUTION
4.9.2006
pursuant to Rule 108(5) of the Rules of Procedure
by Thierry Cornillet
on behalf of the ALDE Group
on the counterfeiting of medicines
B6‑0483/2006
European Parliament resolution on the counterfeiting of medicines
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 and 16 July 2006,
– having regard to information report 2363 of 8 June 2005 by the EU delegation of the French National Assembly on the European Union's fight against counterfeiting,
– 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 in 2005 (C-176/03) which has strengthened the European Community's capacity to impose penal sanctions for counterfeiting,
– having regard to Rule 108(5) of its Rules of Procedure,
A. whereas the counterfeiting of medicines is the most serious and most amoral form of counterfeiting and is a growing evil endangering the health and even the lives of millions of consumers,
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 the Food and Drug Administration puts the figure at more than 10%; 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; 25% of all medicines used in developing countries are apparently counterfeit (50% in Pakistan and Nigeria),
E. whereas 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 counterfeiting of medicines involves distribution channels and production systems worthy of organised crime,
H. whereas there has been a staggering increase in cross-border trade in counterfeit medicines,
I. having regard to the proliferation of medicine distribution systems that are not adequately controlled, such as the Internet,
J. whereas national legal systems are not equipped to deal with the tragic consequences of counterfeiting of medicines,
K. whereas legislation in many countries does not provide adequate deterrent legal sanctions for criminals responsible for the manufacture and distribution of counterfeit medicines,
L. whereas national anti-counterfeiting legislation, where it exists, is not adequately enforced in certain countries,
M. 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 absent 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,
N. regretting that the European Union became involved 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 Community should equip itself as a matter of urgency with the means to combat effectively criminal practices in the area of piracy and the counterfeiting of medicines;
2. Regrets the faintheartedness of the authorities in this area and 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 EU 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;
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 on the Commission and the Member States in particular to enhance the use of intellectual property rights by strengthening measures against counterfeiting and piracy;
6. Calls for greater cooperation at both national and international level between the various authorities involved in anti-counterfeiting measures;
7. 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;
8. Draws attention in particular to the importance of certified drug distribution networks, while allowing a legal form of parallel imports of products of guaranteed origin and calls on the authorities and pharmaceutical companies to continue to guarantee the origin and quality of medicines available;
9. Instructs its President to forward this resolution to the Council, the Commission, the heads of government of the Member States, the UN Secretary-General and the Secretary-General of the WHO.