European Parliament resolution on counterfeiting of medicinal products
Date: 2006-09-07
Institutions: European Parliament
Subjects: developing countries, drug surveillance, industrial counterfeiting, intellectual property, medicinal product, pharmaceutical legislation, public health

C 305 E/246

Official Journal of the European Union

EN

14.12.2006

Thursday 7 September 2006

P6_TA(2006)0351

Counterfeiting of medicinal products

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 Govern-

ment 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 sanc-
tions for counterfeiting,

— having regard to the WHO resolution on ‘public health, innovation, essential health research and intel-

lectual 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 endan-

ger 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 gen-
eric 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 packa-
ging’,

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 Amer-

ica 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,

14.12.2006

EN

Official Journal of the European Union

C 305 E/247

Thursday 7 September 2006

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 exacer-
bate the problem of piracy,

Considers that the European Union should equip itself as a matter of urgency with the means to

1.
combat effectively illicit practices in the area of piracy and the counterfeiting of medicines;

Calls on the Commission to go beyond its communication ‘Strategy to enforce intellectual property
2.
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;

Calls on the European Union to take steps to strengthen the regulatory and quality-control capacity for
3.
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;

Calls for greater cooperation at both national and international level between the various authorities

5.
involved in anti-counterfeiting measures;

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

Instructs its President to forward this resolution to the Council, the Commission, the governments of

7.
the Member States, the UN Secretary-General and the Secretary-General of the WHO.

P6_TA(2006)0352

European contract law

European Parliament resolution on European contract law

The European Parliament,

— having regard to its resolution of 23 March 2006 on European contract law and the revision of the

acquis: the way forward (1),

— having regard to its resolution of 26 May 1989 on action to bring into line the private law of the
Member States (2), 6 May 1994 on the harmonisation of certain sectors of the private law of the Mem-
ber States (3), 15 November 2001 on the approximation of the civil and commercial law of the Member
states (4) and 2 September 2003 on the Communication from the Commission to the European Parlia-
ment and the Council — A more coherent European contract law — An action plan (5),

(1) Texts Adopted, P6_TA(2006)0109.
(2) OJ C 158, 26.6.1989, p. 400.
(3) OJ C 205, 25.7.1994, p. 518.
(4) OJ C 140 E, 13.6.2002, p. 538.
(5) OJ C 76 E, 25.3.2004, p. 95.