[Ip-health] EP Resolution on Counterfeiting medicines

[Alexandra HEUMBER]

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Here below the Resolution adopted by the European Parliament on=0D
counterfeiting medicines on September 6th. French and English versions.=0D
=0D
In the fight of counterfeiting medicines, as defined by WHO (see below=0D
point B), which is a threat to Public Health, It is important to keep=0D
aware that high drug prices, lack of affordability of medicines , in=0D
developing countries are the main cause of counterfeiting medicines. If=0D
people cannot afford the medicines they need, or if they are not available=
=0D
they tend to seek relief in the informal circuit (point H and 3).=0D
=0D
The issue of counterfeiting should not be used as a reason to increase=0D
standards of intellectual property protection. Measures to tackle=0D
counterfeit need to be taken in the area of enforcement and drug=0D
regulation not by increasing levels of IP protection as it is requested by=
=0D
this EP resolution (point 2 and 4). It is important to note that also=0D
medicines that are not patented can be counterfeited as counterfeiting is=
=0D
a trade mark issue.=0D
=0D
Alexandra Heumber=0D
M=C3=A9decins Sans Fronti=C3=A8res=0D
Access to Medicines Campaign=0D
EU Advocacy Liaison Officer=0D
C/O MSF-B=0D
Rue Dupr=C3=A9, 94=0D
1090 Brussels=0D
++32 (0) 2 474 75 09 (Dir off)=0D
++ 32 (0) 479 514 900 (Mob)=0D
++ 32 (0) 2 474 75 75 (Fax)=0D
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=0D
=0D
=0D
=0D
R=C3=A9solution du Parlement europ=C3=A9en sur la contrefa=C3=A7on de m=C3=
=A9dicaments=0D
=0D
=0D
Le Parlement europ=C3=A9en,=0D
=E2=80=93 vu la d=C3=A9claration sur la lutte contre la contrefa=C3=A7on de=
s chefs d'=C3=89tat et=0D
de gouvernement du G8 lors du Sommet de Saint-P=C3=A9tersbourg les 15 et 16=
=0D
juillet 2006,=0D
=E2=80=93 vu la d=C3=A9claration de Rome lors de la Conf=C3=A9rence interna=
tionale de l'OMS=0D
du 18 f=C3=A9vrier 2006,=0D
=E2=80=93 vu les initiatives de la Commission en mati=C3=A8re de respect de=
s droits de=0D
propri=C3=A9t=C3=A9 intellectuelle et son plan d'action contre la contrefa=
=C3=A7on et la=0D
piraterie, adopt=C3=A9 en octobre 2005,=0D
=E2=80=93 vu l'arr=C3=AAt de la Cour de justice europ=C3=A9enne en 2005 (C=
=E2=80=91176/03) qui a=0D
renforc=C3=A9 la capacit=C3=A9 de la Communaut=C3=A9 europ=C3=A9enne d'=C3=
=A9dicter des sanctions=0D
p=C3=A9nales en mati=C3=A8re de contrefa=C3=A7on,=0D
=E2=80=93 vu la r=C3=A9solution de l'OMS "Sant=C3=A9 publique, innovation, =
recherche=0D
essentielle en sant=C3=A9 et droits de propri=C3=A9t=C3=A9 intellectuelle",=
 adopt=C3=A9e le 29=0D
mai 2006,=0D
=E2=80=93 vu l'article 108, paragraphe 5, de son r=C3=A8glement,=0D
A. consid=C3=A9rant les cons=C3=A9quences extr=C3=AAmement graves de la con=
trefa=C3=A7on de=0D
m=C3=A9dicaments, risquant m=C3=AAme de mettre en danger la sant=C3=A9 et l=
a vie de=0D
millions de personnes;=0D
B. consid=C3=A9rant que selon l'OMS, "un m=C3=A9dicament contrefait est un=
=0D
m=C3=A9dicament qui est d=C3=A9lib=C3=A9r=C3=A9ment et frauduleusement muni=
 d'une =C3=A9tiquette=0D
qui contient des informations trompeuses quant =C3=A0 son identit=C3=A9 et/=
ou sa=0D
source v=C3=A9ritable. Il peut s'agir d'une sp=C3=A9cialit=C3=A9 originale =
ou d'un=0D
produit g=C3=A9n=C3=A9rique et parmi les produits contrefaits, il en est qu=
i=0D
contiennent les bons ingr=C3=A9dients ou de mauvais ingr=C3=A9dients, ou bi=
en encore=0D
pas de principe actif, et il en est d'autres o=C3=B9 le principe actif est =
en=0D
quantit=C3=A9 insuffisante ou dont le conditionnement a =C3=A9t=C3=A9 falsi=
fi=C3=A9",=0D
C. constatant que ces m=C3=A9dicaments contrefaits circulent essentiellemen=
t=0D
dans les pays en voie de d=C3=A9veloppement et qu'ils sont utilis=C3=A9s co=
ntre des=0D
affections mortelles comme le paludisme, la tuberculose et le VIH/SIDA,=0D
D. consid=C3=A9rant que la contrefa=C3=A7on de m=C3=A9dicaments concerne au=
jourd'hui,=0D
selon les estimations de l'OMS, 10% du march=C3=A9 mondial et plus de 10% s=
elon=0D
la Food and Drug Administration; jusqu'=C3=A0 70% des m=C3=A9dicaments anti=
palud=C3=A9ens=0D
circulant au Cameroun s'av=C3=A8rent contrefaits, chiffre corrobor=C3=A9 po=
ur six=0D
autres pays africains par l'OMS en 2003; 25% des m=C3=A9dicaments consomm=
=C3=A9s=0D
dans les pays en voie de d=C3=A9veloppement seraient des contrefa=C3=A7ons =
(50% au=0D
Pakistan ou au Nig=C3=A9ria),=0D
E. constatant que, selon l'OMS, sur le million de d=C3=A9c=C3=A8s annuels p=
ar=0D
paludisme, 200 000 sont =C3=A0 mettre sur le compte de m=C3=A9dicaments mal=
=0D
administr=C3=A9s ou de consommation de m=C3=A9dicaments contrefaits,=0D
F. consid=C3=A9rant que la contrefa=C3=A7on de m=C3=A9dicaments s=C3=A9vit =
sur tous les=0D
continents et principalement en Afrique, Asie, Am=C3=A9rique latine et Russ=
ie,=0D
G. consid=C3=A9rant que les facteurs les plus courants indiqu=C3=A9s par l'=
OMS=0D
favorisant l'apparition de m=C3=A9dicaments contrefaits sont: l'absence d'u=
ne=0D
l=C3=A9gislation interdisant la contrefa=C3=A7on des m=C3=A9dicaments, la f=
aiblesse des=0D
sanctions p=C3=A9nales, la faiblesse ou l'absence des autorit=C3=A9s nation=
ales de=0D
r=C3=A9glementation dans le domaine pharmaceutique, les p=C3=A9nuries ou=0D
l'approvisionnement al=C3=A9atoires de m=C3=A9dicaments, l'absence de contr=
=C3=B4le des=0D
m=C3=A9dicaments =C3=A0 l'exportation, les transactions commerciales impliq=
uant=0D
plusieurs interm=C3=A9diaires, la corruption et les conflits d'int=C3=A9r=
=C3=AAts;=0D
H. consid=C3=A9rant que ce trafic de faux m=C3=A9dicaments r=C3=A9sulte =C3=
=A9galement de=0D
l'absence de sensibilisation et d'engagement politiques, est d=C3=BB =C3=A0=
 la=0D
faiblesse des r=C3=A9glementations, =C3=A0 une capacit=C3=A9 de mise en =C5=
=93uvre inad=C3=A9quate=0D
et, notamment dans les pays en d=C3=A9veloppement, au manque d'acc=C3=A8s d=
es=0D
populations aux m=C3=A9dicaments v=C3=A9ritables, contr=C3=B4l=C3=A9s par l=
es autorit=C3=A9s=0D
publiques;=0D
I. regrettant que l'Union europ=C3=A9enne soit entr=C3=A9e tardivement dans=
 le=0D
domaine de la lutte internationale "anti-contrefa=C3=A7on", alors que la=0D
porosit=C3=A9 accrue des fronti=C3=A8res et les nouvelles technologies (Int=
ernet)=0D
risquaient d'amplifier le ph=C3=A9nom=C3=A8ne de la piraterie;=0D
1. estime que la Communaut=C3=A9 europ=C3=A9enne doit de toute urgence se d=
onner les=0D
moyens pour mener =C3=A0 bien son combat contre les pratiques illicites dan=
s le=0D
domaine de la piraterie et de la contrefa=C3=A7on des m=C3=A9dicaments;=0D
2. invite la Commission =C3=A0 aller au-del=C3=A0 de sa communication intit=
ul=C3=A9e=0D
"Strat=C3=A9gie visant =C3=A0 assurer le respect des droits de propri=C3=A9=
t=C3=A9=0D
intellectuelle dans les pays tiers"; encourage, en particulier, l'Union=0D
europ=C3=A9enne =C3=A0 prendre les mesures ad=C3=A9quates pour lutter contr=
e le fl=C3=A9au de=0D
la contrefa=C3=A7on de m=C3=A9dicaments sur son territoire;=0D
3. invite l'UE =C3=A0 prendre des initiatives pour renforcer dans les pays =
=C3=A0=0D
faibles ressources les capacit=C3=A9s de r=C3=A9glementation et de contr=C3=
=B4le de la=0D
qualit=C3=A9 des produits et mat=C3=A9riel m=C3=A9dicaux mis sur le march=
=C3=A9 et d'am=C3=A9liorer=0D
l'acc=C3=A8s =C3=A0 des m=C3=A9dicaments =C3=A0 un prix abordable;=0D
4. incite fortement l'Union europ=C3=A9enne =C3=A0 jouer un r=C3=B4le moteu=
r dans la=0D
promotion d'une Convention mondiale tendant =C3=A0 cr=C3=A9er dans la l=C3=
=A9gislation de=0D
chaque pays une incrimination p=C3=A9nale sp=C3=A9cifique (crime ou d=C3=A9=
lit)=0D
concernant la contrefa=C3=A7on de m=C3=A9dicaments et le recel et la distri=
bution de=0D
m=C3=A9dicaments contrefaits;=0D
5. demande instamment de renforcer la coop=C3=A9ration autant sur le plan=
=0D
national que transnational entre les diff=C3=A9rentes autorit=C3=A9s impliq=
u=C3=A9es dans=0D
les actions anti-contrefa=C3=A7on;=0D
6. insiste sur l'importance des mesures pr=C3=A9ventives dans les programme=
s=0D
d'action: en l'occurrence la mise en place de structures, la coop=C3=A9rati=
on,=0D
des campagnes de sensibilisation =C3=A0 mener de pr=C3=A9f=C3=A9rence par l=
es autorit=C3=A9s=0D
publiques, la volont=C3=A9 politique, enfin, pour mener =C3=A0 bien ces act=
ions;=0D
7. charge son Pr=C3=A9sident de transmettre la pr=C3=A9sente r=C3=A9solutio=
n au Conseil,=0D
=C3=A0 la Commission, aux chefs de gouvernement des =C3=89tats membres, au=
=0D
Secr=C3=A9taire g=C3=A9n=C3=A9ral de l'ONU et au Secr=C3=A9taire g=C3=A9n=
=C3=A9ral de l'OMS.=0D
=0D
=0D
=0D
Derni=C3=A8re mise =C3=A0 jour: 6 septembre 2006=0D
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=0D
=0D
European Parliament resolution on counterfeiting of medicinal products=0D
=0D
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The European Parliament,=0D
=E2=80=93 having regard to the statement on the fight against counterfeitin=
g by=0D
the Heads of State and Government of the G8 at the St Petersburg Summit on=
=0D
15 and 16 July 2006,=0D
=E2=80=93 having regard to the Declaration of Rome adopted at the WHO=0D
international conference of 18 February 2006,=0D
=E2=80=93 having regard to the Commission=E2=80=99s initiatives on enforcin=
g intellectual=0D
property rights and its action plan against counterfeiting and piracy=0D
adopted in October 2005,=0D
=E2=80=93 having regard to the judgment of the Court of Justice in 2005 (C-=
176/03)=0D
which has strengthened the European Community=E2=80=99s capacity to impose =
penal=0D
sanctions for counterfeiting,=0D
=E2=80=93 having regard to the WHO resolution on =E2=80=98public health, in=
novation,=0D
essential health research and intellectual property rights=E2=80=99 adopted=
 on 29=0D
May 2006,=0D
=E2=80=93 having regard to Rule 108(5) of its Rules of Procedure,=0D
A. whereas the counterfeiting of medicines can have extremely serious=0D
consequences and may well endanger the health and life of millions of=0D
people,=0D
B. whereas, according to the WHO, =E2=80=98a counterfeit medicine is one wh=
ich is=0D
deliberately and fraudulently mislabelled with respect to identity and/or=
=0D
source. Counterfeiting can apply to both branded and generic products and=
=0D
counterfeit products may include products with the correct ingredients or=
=0D
with the wrong ingredients, without active ingredients, with insufficient=
=0D
active ingredients or with fake packaging=E2=80=99,=0D
C. whereas counterfeit medicines are primarily circulating in developing=0D
countries and are used to treat fatal conditions such as malaria,=0D
tuberculosis and HIV/AIDS,=0D
D. whereas the WHO estimates that the counterfeiting of medicines now=0D
affects 10% of the world market, and the Food and Drug Administration puts=
=0D
the figure at more than 10%; up to 70% of anti-malaria drugs circulating=0D
in Cameroon are counterfeit, a figure confirmed for six other African=0D
countries by the WHO in 2003; 25% of all medicines used in developing=0D
countries are apparently counterfeit (50% in Pakistan and Nigeria),=0D
E. whereas, according to the WHO, 200 000 of the one million deaths a year=
=0D
from malaria are attributable to medicines wrongly administered or the=0D
administration of counterfeit medicines,=0D
F. whereas the counterfeiting of medicines is rife in all continents but=0D
mainly in Africa, Asia, Latin America and Russia,=0D
G. whereas the most common factors identified by the WHO as encouraging=0D
the appearance of counterfeit medicines are: the lack of legislation=0D
prohibiting counterfeiting of medicines, weak penal sanctions, weak or=0D
absent national drug regulatory authorities, shortages/erratic supply of=0D
medicines, lack of control of drugs for export, trade involving several=0D
intermediaries, corruption and conflict of interest,=0D
H. whereas this trafficking in fake medicines is also a consequence of the=
=0D
lack of political awareness and commitment, weak regulatory systems,=0D
inadequate enforcement capacity and, especially in developing countries,=0D
the lack of public access to genuine medicines supervised by the public=0D
authorities,=0D
I. regretting that the European Union became involved at a late stage in=0D
the international fight against counterfeiting when more open borders and=
=0D
new technologies (Internet) were likely to exacerbate the problem of=0D
piracy,=0D
1. Considers that the European Community should equip itself as a matter=0D
of urgency with the means to combat effectively illicit practices in the=0D
area of piracy and the counterfeiting of medicines;=0D
2. Calls on the Commission to go beyond its communication =E2=80=98Strategy=
 to=0D
enforce intellectual property rights in third countries=E2=80=99; in partic=
ular,=0D
urges the European Union to take adequate measures to combat the scourge=0D
of counterfeiting of medicines in its territory;=0D
3. Calls on the EU to take steps to strengthen the regulatory and=0D
quality-control capacity for medicinal products and medical equipment put=
=0D
on the market in countries with inadequate resources and to improve access=
=0D
to affordable medicines;=0D
4. Urges the European Union to play a key role in promoting an=0D
international convention to create a specific criminal offence of=0D
counterfeiting or the receiving and distribution of counterfeit medicines=
=0D
in the legislation of every country;=0D
5. Calls for greater cooperation at both national and international level=
=0D
between the various authorities involved in anti-counterfeiting measures;=
=0D
6. Emphasises the importance of preventive measures in action programmes,=
=0D
more specifically, the establishment of structures, cooperation, awareness=
=0D
campaigns, preferably carried out by the public authorities, and finally=0D
the political will to carry through such measures successfully;=0D
7. Instructs its President to forward this resolution to the Council, the=
=0D
Commission, the heads of government of the Member States, the UN=0D
Secretary-General and the Secretary-General of the WHO.=0D
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=0D
=0D
Last updated: 6 September 2006=0D
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