E-DRUG: EP Resolution on Counterfeiting medicines
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Here below the Resolution adopted by the European Parliament on
counterfeiting medicines on September 6th. French and English versions.
In the fight of counterfeiting medicines, as defined by WHO (see below
point B), which is a threat to Public Health, It is important to keep
aware that high drug prices, lack of affordability of medicines , in
developing countries are the main cause of counterfeiting medicines. If
people cannot afford the medicines they need, or if they are not available
they tend to seek relief in the informal circuit (point H and 3).
The issue of counterfeiting should not be used as a reason to increase
standards of intellectual property protection. Measures to tackle
counterfeit need to be taken in the area of enforcement and drug
regulation not by increasing levels of IP protection as it is requested by
this EP resolution (point 2 and 4). It is important to note that also
medicines that are not patented can be counterfeited as counterfeiting is
a trade mark issue.
Alexandra Heumber
Medecins Sans Frontieres
Access to Medicines Campaign
EU Advocacy Liaison Officer
C/O MSF-B
Rue Dupre, 94
1090 Brussels
++32 (0) 2 474 75 09 (Dir off)
++ 32 (0) 479 514 900 (Mob)
++ 32 (0) 2 474 75 75 (Fax)
European Parliament resolution on counterfeiting of medicinal products
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 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 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 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, 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
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,
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 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 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 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 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 heads of government of the Member States, the UN
Secretary-General and the Secretary-General of the WHO.
Last updated: 6 September 2006