[Ip-health] European Parliament Questions and Resolution to the Commission and EU Council on Access to medicines TRIPs

Tue Jul 10 10:26:12 2007

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FYI- Tomorrow Wednesday 11th, during the plenary session from 4:00 pm the=
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Commission and the EU Council will reply to the MEPs questions below:=0D
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http://www.europarl.europa.eu/sides/getDoc.do?type=3DOQ&language=3DEN&refer=
ence=3DO-2007-0037&secondRef=3D0=0D
(to the Commission)=0D
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http://www.europarl.europa.eu/sides/getDoc.do?type=3DOQ&language=3DEN&refer=
ence=3DO-2007-0036&secondRef=3D0=0D
(to the EU Council)=0D
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On Thursday 12th, the European Parliament will vote the following motion=0D
for Resolution tabled by all the political groups:=0D
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http://www.europarl.europa.eu/sides/getDoc.do?pubRef=3D-//EP//NONSGML+MOTIO=
N+B6-2007-0288+0+DOC+PDF+V0//EN=0D
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Alexandra Heumber=0D
EU Advocacy Liaison Officer=0D
M=C3=A9decins Sans Fronti=C3=A8res=0D
Access to Essential Medicines Campaign=0D
Rue Dupr=C3=A9, 94. 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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MOTION FOR A RESOLUTION=0D
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9 July 2007=0D
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PE 393.003v01-00=0D
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B6=E2=80=910288/2007=0D
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further to Questions for Oral Answer B6=E2=80=910134/2007=0D
pursuant to Rule 108(5) of the Rules of Procedure=0D
by Georgios Papastamkos on behalf of the EPP-ED Group=0D
by Kader Arif on behalf of the PSE Group=0D
by Gianluca Susta, Johan Van Hecke and Ignasi Guardans Camb=C3=B3 on behalf=
 of=0D
the ALDE Group=0D
by Cristiana Muscardini on behalf of the UEN Group=0D
by Carl Schlyter and Caroline Lucas on behalf of the Greens Group=0D
by Helmuth Markov and Vittorio Agnoletto on behalf of the GUE Group=0D
on the TRIPS Agreement and access to medicines=0D
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European Parliament resolution on the TRIPS Agreement and access to=0D
medicines=0D
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B6=E2=80=910288/2007=0D
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The European Parliament,=0D
=E2=80=93  having regard to its resolutions of 20 June 2007 on the Millenni=
um=0D
Development Goals =E2=80=93 the midway point(1), of 23 May 2007 on Economic=
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Partnership Agreements(2), and of 30 November 2006 on AIDS(3),=0D
=E2=80=93  having regard to the proposal for a Council decision accepting, =
on=0D
behalf of the European Community, the Protocol amending the Agreement on=0D
Trade-Related Aspects of Intellectual Property Rights (TRIPS), done at=0D
Geneva on 6 December 2005 (COM(2006) 175 fin.)(4),=0D
=E2=80=93  having regard to Regulation No 816/2006(5) of the European Parli=
ament=0D
and of the Council of 16 May 2006 on compulsory licensing of patents=0D
relating to the manufacture of pharmaceutical products for export to=0D
countries with public health problems,=0D
=E2=80=93  having regard to the Agreement on Trade-Related Aspects of Intel=
lectual=0D
Property Rights (hereinafter =E2=80=98TRIPS Agreement=E2=80=99) adopted in =
April 1994,=0D
=E2=80=93  having regard to the Doha Declaration on the TRIPS Agreement and=
 Public=0D
Health adopted on 14 November by the Ministerial Conference of the World=0D
Trade Organization (WTO) (hereinafter =E2=80=98Doha Declaration=E2=80=99)(6=
),=0D
=E2=80=93  having regard to the Decision of the General Council of the WTO =
of 30=0D
August 2003 (hereinafter =E2=80=98WTO Decision=E2=80=99) adopted pursuant t=
o Paragraph 6=0D
of the Doha Declaration on the TRIPS Agreement and Public Health,=0D
=E2=80=93  having regard to the Protocol amending the Agreement on Trade-Re=
lated=0D
Aspects of Intellectual Property Rights (TRIPS), done at Geneva on 6=0D
December 2005 (hereinafter =E2=80=98Protocol=E2=80=99,=0D
=E2=80=93  having regard to Rule 108(5) of its Rules of Procedure,=0D
A.  whereas over 95% of the 39.5 million people in the world suffering=0D
from HIV/AIDS live in developing countries, mostly in Africa; whereas=0D
there are an estimated 15 million HIV/AIDS orphans globally, 12.3 million=
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of them living in Sub-Saharan Africa,=0D
B.  whereas before the entry into force in 1994 of the TRIPS Agreement the=
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ability of some middle-income developing countries to produce low-cost=0D
generic medicines increased, and even very poor states started to become=0D
able to obtain certain low-cost generic medicines on the world market,=0D
whether such products were on or off patents,=0D
C.  whereas the Doha Declaration reconfirmed the so-called flexibilities=0D
built into the TRIPS Agreement and amplified them further by establishing=
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legal machinery to enable countries lacking the capacity to manufacture=0D
generic substitutes for costly patented medicines under domestically=0D
issued compulsory licenses to obtain imports from countries able and=0D
willing to assist them without interference from the relevant patent=0D
holders,=0D
D.  whereas this solution, initially embodied in a waiver known as the WTO=
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Decision, could be rendered permanent in the form of a Protocol to the=0D
TRIPS Agreement whose acceptance is currently under consideration by the=0D
European Parliament,=0D
E.  whereas Article 30 of the TRIPS Agreement allows members to =E2=80=98pr=
ovide=0D
limited exceptions to the exclusive rights conferred by a patent, provided=
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that such exceptions do not unreasonably conflict with a normal=0D
exploitation of the patent and do not unreasonably prejudice the=0D
legitimate interests of the patent owner, taking account of the legitimate=
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interests of third parties=E2=80=99; whereas, because the assisting country=
 would=0D
export needed medicines to the importing country, there should be no=0D
significant economic impact on the local market of the exporting country,=
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F.  whereas no country has so far made an official notification to the=0D
Council for TRIPS of intent to use the mechanism created by the WTO=0D
Decision to import cheaper medicines,=0D
G.  whereas the procedural and substantive requirements that govern the=0D
issuance of compulsory licenses by importing (where applicable) and=0D
exporting countries, as well as the conditions and notifications connected=
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with that licensing, constitute the principal potential obstacles to=0D
effective use of the WTO Decision,=0D
H.  whereas the European Union has already transposed the WTO Decision=0D
into internal law, and consequently delaying acceptance of the Protocol=0D
until after 1 December 2007 would not create a legal vacuum,=0D
I.  whereas the European Union should expressly endorse full=0D
implementation in the developing countries of the flexibilities in the=0D
TRIPS Agreement as recognized in the Doha Declaration =E2=80=98to promote a=
ccess=0D
to medicines for all=E2=80=99,=0D
J.  whereas the implementing Regulation for the WTO Decision pays scant=0D
attention to issues of technology transfer and capacity-building,=0D
K.  whereas through the EPA negotiations and other bilateral or regional=0D
FTAs, the European Union proposes to include new intellectual property=0D
WTO+ obligations on ACP and other poor developing countries and LDCs,=0D
including the adherence to or the acceptance of the obligations of the=0D
Patent Cooperation Treaty (PCT) and the Patent Law Treaty (PLT), and the=0D
incorporation of the terms of Directive 2004/48/EC on the enforcement of=0D
intellectual property rights; whereas the EU also sets conditions on the=0D
way that parties can determine their regime of exhaustion,=0D
1.  Stresses that access to affordable pharmaceutical products in poor=0D
developing countries and LDCs is essential to attain the proposed EU=0D
development goals and would contribute to poverty reduction, increase=0D
human security, and promote human rights and sustainable development;=0D
2.  Believes that the EU policy should aim at maximizing the availability=
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of pharmaceutical products at affordable prices in the developing world;=0D
3.  Calls on the Council to recognise that the European Union must take=0D
additional measures as a matter of urgency with a view to encouraging the=
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transfer of technology, research, capacity strengthening, regional supply=
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systems and help with registration, in order to facilitate and increase=0D
the production of pharmaceutical products by the developing countries=0D
themselves;=0D
4.  Asks the Commission and the Member States to provide concrete=0D
financial support for pharmaceutical-related transfer of technology and=0D
capacity building for developing countries and local production of=0D
pharmaceuticals in all developing countries, especially LDCs, in=0D
discharging the obligations established by Article 66.2 of the TRIPS=0D
Agreement;=0D
5.  Asks the Council to commit to a specified level of funding to upgrade=
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or construct pharmaceutical production facilities owned by local persons=0D
in developing countries (including LDCs), and increase the EU aggregate=0D
funding to Public-Private Partnerships pursuing research and development=0D
of medicines of special relevance to developing countries;=0D
6.  Asks the Commission to grant funding for R&D on poverty-related,=0D
tropical and neglected diseases across a broad spectrum of venues,=0D
including Public-Private Partnerships and other possible funding ventures,=
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and to support research institutes willing to cooperate with public health=
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initiatives dedicated to these efforts;=0D
7.  Asks the Council to support the idea that the mechanism created by the=
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WTO Decision and the Protocol to the TRIPS Agreement represents just a=0D
part of the solution to the problem of access to medicines and public=0D
health and that other measures to improve health care and infrastructure=0D
are equally indispensable;=0D
8.  Asks the Council to support the developing countries which use the=0D
so-called flexibilities built into the TRIPS Agreement and recognized by=0D
the Doha Declaration in order to be able to provide essential medicines at=
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affordable prices under their domestic public health programmes;=0D
9.  Encourages the developing countries to use all means available to them=
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under the TRIPS Agreement, such as compulsory licences and the mechanism=0D
provided by Article 30;=0D
10.  Calls on the Council to adopt a Joint Policy Statement with the=0D
European Parliament to the effect that EU Member States remain free to use=
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all exception provisions of the TRIPS Agreement under their domestic=0D
patent laws to authorise production and export =E2=80=98to address public h=
ealth=0D
needs in importing Members=E2=80=99 and asks the Council to mandate the Com=
mission=0D
to refrain from taking action to interfere with these proceedings;=0D
11.  Calls on the Council to deliver on the Doha declaration on public=0D
health and to restrict the mandate to the Commission in order not to=0D
negotiate pharmaceutical-related TRIPS-plus provisions affecting public=0D
health and access to medicines, such as data exclusivity, patent=0D
extensions and limitation of grounds of compulsory licenses, in the=0D
framework of the negotiation of the Economic Partnership Agreements (EPAs)=
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with the ACP countries and other future bilateral and regional agreements=
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with developing countries;=0D
12.  Asks the Commission to support disclosure by patent applicants of the=
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source and origin of inventions deriving from biological resources and=0D
associated traditional knowledge found in developing countries with a view=
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to promoting the equitable sharing of benefits and technology derived from=
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those resources by supplying countries;=0D
13.  Calls on the Commission to support =E2=80=98pool procurement strategie=
s=E2=80=99=0D
under Article 31(b) and other strategies which could be used by countries=
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or groups of countries to provide greater buying power and economies of=0D
scale in the production of generic medicines at affordable prices and=0D
stimulate direct investment in local production facilities within a=0D
region;=0D
14.  Asks the Council to mandate the European Commission to proactively=0D
support the work of the Intergovernmental Working Group on Public Health,=
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Innovation and Intellectual Property (IGWG) at the WHO and to report=0D
regularly to the European Parliament on its work;=0D
15.  Encourages pharmaceutical companies to pursue pricing alternatives=0D
involving a high-volume, low-margin approach, which could enhance access=0D
to medicines;=0D
16.  Recalls that counterfeiting of medicines is not a patent issue as=0D
such; stresses that measures to tackle counterfeiting need to be taken in=
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the area of criminal enforcement (penal sanctions) and drug regulation by=
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reinforcing the regulatory capacity of the national authorities and not by=
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increasing levels of intellectual property protection;=0D
17.  Calls on LDCs and other poor countries to take the necessary measures=
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to prevent medicines covered by compulsory licensing leaving the country=0D
and ensuring that the medicines go to the local population in need;=0D
18.  Instructs its President to forward this resolution to the Council,=0D
the Commission, the Governments of the EU Member States and ACP countries,=
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the WTO and the heads of UNAIDS, UNDP and UNFPA.=0D
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(1)=0D
Texts Adopted, P6_TA(2007)0274.=0D
(2)=0D
Texts Adopted, P6_TA(2007)0204.=0D
(3)=0D
Texts Adopted, P6_TA(2006)0526.=0D
(4)=0D
OJ C ... / Not yet published in OJ.=0D
(5)=0D
OJ L 157, 9.06.2007. page 1.=0D
(6)=0D
WT/MIN(01)/DEC/W/2, 14 November 2001.=0D
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Last updated: 10 July 2007=0D
Legal notice=0D
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