[Ip-health] EU to ask WTO to rule on Thailand's druglicensing- The Nation
Richard Elliott
RElliott@aidslaw.ca
Thu Mar 13 17:29:17 2008
Just a quick clarification about an inaccuracy in the EP resolution:
Preambular paragraph F says:
"F. whereas no country has so far made an official notification to the
Council for TRIPS of its intention to use the mechanism created by the
WTO Decision to import cheaper medicines,"
But this is inaccurate. In July 2007, Rwanda filed the first notification
with the WTO of its intent to use the August 30, 2003 mechanism to import a
generic ARV from manufacturer Apotex under the Canadian legislation that
implements that mechanism. In September 2007, the first compulsory licence
under the Canadian legislation was issued to Apotex, based on that
notification.
To the best of my knowledge, no exports have yet occurred under this
compulsory licence, and my understanding is that a process of tendering and
bidding to supply Rwanda needs to be completed first.
For more, see: http://www.ictsd.org/weekly/07-10-10/story4.htm.
Richard
-----Original Message-----
From: ip-health-admin@lists.essential.org
[mailto:ip-health-admin@lists.essential.org] On Behalf Of J=E9r=F4me Martin
Sent: Tuesday, March 11, 2008 6:09 AM
To: IP Heath
Subject: Re: [Ip-health] EU to ask WTO to rule on Thailand's druglicensing-
The Nation
The article sent by Alexandra says "The EU, pushed particularly by
Germany and France, recently said it would file a complaint against
Thailand for breaking the international agreement on compulsory
licensing"
Please find below a resolution a European Parliament resolution of 12
July 2007 on the TRIPS Agreement and access to medicines that :
"8. Asks the Council to support the developing countries which use the
so-called flexibilities built into the TRIPS Agreement and recognized by
the Doha Declaration in order to be able to provide essential medicines
at affordable prices under their domestic public health programmes;
9. Encourages the developing countries to use all means available to
them under the TRIPS Agreement, such as compulsory licences and the
mechanism provided by Article 30 thereof"
So if there is any pressure from European Council or European Commission
(whose members are NOT elected by european people), this is in
opposition to European Parliament (whose members ARE elected). Thus
these pressures are not legitimate,
See also European Commissioner Mandelson's letter to the previous
governement, the answer of the MoH and Act Up-Paris's one :
http://www.actupparis.org/IMG/pdf/Letter_from_Mandelson_to_Thailand.pdf
http://www.actupparis.org/IMG/pdf/Answer_Thai.pdf
http://www.actupparis.org/IMG/pdf/Letter_from_Aides_Actup-Paris_to_Mandelso=
n
.pdf
Best
J=E9r=F4me Martin / Miss Heat Stable
Act Up-Paris
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=3D-//EP//TEXT+TA
+P6-TA-2007-0353+0+DOC+XML+V0//EN
Texts adopted by Parliament
DOC 46k
Thursday, 12 July 2007 - Strasbourg
Final edition
TRIPS Agreement and access to
medicines
P6_TA(2007)0353
B6-0288/2007
European Parliament resolution of 12 July 2007 on the TRIPS Agreement
and access to medicines
The European Parliament ,
=96 having regard to its resolutions of 20 June 2007 on the Millennium
Development Goals =96 the midway point(1) , of 23 May 2007 on Economic
Partnership Agreements(2) , and of 30 November 2006 on AIDS(3) ,
=96 having regard to the proposal for a Council decision accepting, on
behalf of the European Community, of the Protocol amending the Agreement
on Trade-Related Aspects of Intellectual Property Rights (TRIPS), done
at Geneva on 6 December 2005 (COM(2006) 0175),
=96 having regard to Regulation (EC) No 816/2006 of the European
Parliament and of the Council of 17 May 2006 on compulsory licensing of
patents relating to the manufacture of pharmaceutical products for
export to countries with public health problems(4) ,
=96 having regard to the Agreement on Trade-Related Aspects of
Intellectual Property Rights ("TRIPS Agreement") adopted in Marrakesh on
15 April 1994,
=96 having regard to the Doha Declaration on the TRIPS Agreement and
Public Health adopted on 14 November 2001 by the Ministerial Conference
of the World Trade Organization (WTO) ("Doha Declaration")(5) ,
=96 having regard to the Decision of the WTO General Council of 30
August 2003 ("WTO Decision") adopted pursuant to Paragraph 6 of the Doha
Declaration on the TRIPS Agreement and Public Health,
=96 having regard to the Protocol amending the Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS), done at
Geneva on 6 December 2005 ("Protocol",
=96 having regard to Rule 108(5) of its Rules of Procedure,
A. whereas over 95% of the 39.5 million people in the world suffering
from HIV/AIDS live in developing countries, mostly in Africa; whereas
there are an estimated 15 million HIV/AIDS orphans globally, 12.3
million of them living in Sub-Saharan Africa,
B. whereas before the entry into force in 1994 of the TRIPS Agreement,
the ability of some middle-income developing countries to produce
low-cost generic medicines increased, and even very poor States started
to become able to obtain certain low-cost generic medicines on the world
market, regardless of whether such products were still patent-protected
or not,
C. whereas the Doha Declaration reconfirmed the so-called
flexibilities built into the TRIPS Agreement and amplified them further
by establishing legal machinery to enable countries lacking the capacity
to manufacture generic substitutes for costly patented medicines under
domestically issued compulsory licences to obtain imports from countries
able and willing to assist them without interference from the relevant
patent holders,
D. whereas this solution, initially embodied in a waiver known as the
WTO Decision, could be rendered permanent in the form of a Protocol to
the TRIPS Agreement whose acceptance is currently under consideration by
Parliament,
E. whereas Article 30 of the TRIPS Agreement allows members to
"provide limited exceptions to the exclusive rights conferred by a
patent, provided that such exceptions do not unreasonably conflict with
a normal exploitation of the patent and do not unreasonably prejudice
the legitimate interests of the patent owner, taking account of the
legitimate interests of third parties"; whereas, because the assisting
country would export needed medicines to the importing country, there
should be no significant economic impact on the local market of the
exporting country,
F. whereas no country has so far made an official notification to the
Council for TRIPS of its intention to use the mechanism created by the
WTO Decision to import cheaper medicines,
G. whereas the procedural and substantive requirements that govern the
issuance of compulsory licences by importing (where applicable) and
exporting countries, as well as the conditions and notifications
connected with that licensing, constitute the principal potential
obstacles to the effective use of the WTO Decision,
H. whereas the Member States have already transposed the WTO Decision
into internal law, and consequently delaying acceptance of the Protocol
until after 1 December 2007 would not create a legal vacuum,
I. whereas the EU should expressly endorse full implementation in the
developing countries of the flexibilities in the TRIPS Agreement as
recognized in the Doha Declaration "to promote access to medicines for
all",
J. whereas the implementing Regulation for the WTO Decision pays scant
attention to issues of technology transfer and capacity-building,
K. whereas through the Economic Partnership Agreement (EPA)
negotiations and other bilateral or regional Free Trade Agreements
(FTAs), the EU proposes to impose new intellectual property "WTO+"
obligations on the countries of Africa, the Caribbean and the Pacific
(ACP) and other poor developing countries and the least developed
countries (LDCs), including adherence to or acceptance of the
obligations of the Patent Cooperation Treaty (PCT) and the Patent Law
Treaty (PLT), and the incorporation of the terms of Directive 2004/48/EC
of the European Parliament and the Council of 29 April 2004 on the
enforcement of intellectual property rights(6) ; whereas the EU also
sets conditions on the way in which parties can determine their regime
of exhaustion,
1. S tresses that access to affordable pharmaceutical products in poor
developing countries and LDCs is essential to attain the proposed EU
development goals and would contribute to poverty reduction, increase
human security, and promote human rights and sustainable development;
2. Believes that EU policy should aim at maximizing the availability of
pharmaceutical products at affordable prices in the developing world;
3. Calls on the Council to recognise that the EU must take additional
measures as a matter of urgency with a view to encouraging the transfer
of technology, research, capacity strengthening, regional supply systems
and help with registration, in order to facilitate and increase the
production of pharmaceutical products by the developing countries
themselves;
4. Asks the Commission and the Member States to provide concrete
financial support for pharmaceutical-related transfer of technology and
capacity-building for developing countries and local production of
pharmaceuticals in all developing countries, especially LDCs, in
discharging the obligations established by Article 66.2 of the TRIPS
Agreement;
5. Asks the Council to commit to a specified level of funding to
upgrade or construct pharmaceutical production facilities owned by local
persons in developing countries (including LDCs), and increase the EU's
aggregate funding to Public-Private Partnerships pursuing research and
development of medicines of special relevance to developing countries;
6. Asks the Commission to grant funding for research and development on
poverty-related, tropical and neglected diseases across a broad spectrum
of locations, including Public-Private Partnerships and other possible
funding ventures, and to support research institutes willing to
cooperate with public health initiatives dedicated to these efforts;
7. Asks the Council to support the idea that the mechanism created by
the WTO Decision and the Protocol to the TRIPS Agreement represents just
a part of the solution to the problem of access to medicines and public
health and that other measures to improve health care and infrastructure
are equally indispensable;
8. Asks the Council to support the developing countries which use the
so-called flexibilities built into the TRIPS Agreement and recognized by
the Doha Declaration in order to be able to provide essential medicines
at affordable prices under their domestic public health programmes;
9. Encourages the developing countries to use all means available to
them under the TRIPS Agreement, such as compulsory licences and the
mechanism provided by Article 30 thereof;
10. Calls on the Council to adopt a Joint Policy Statement with
Parliament to the effect that the Member States remain free to use all
exceptions from the TRIPS Agreement under their domestic patent laws to
authorise production and export "to address public health needs in
importing Members" and asks the Council to ensure that the Commission
refrains from taking action to interfere with these proceedings;
11. Calls on the Council to meet its commitments to the Doha
Declaration and to restrict the Commission's mandate so as to prevent it
from negotiating pharmaceutical-related TRIPS-plus provisions affecting
public health and access to medicines, such as data exclusivity, patent
extensions and limitation of grounds of compulsory licences, within the
framework of the EPA negotiations with the ACP countries and other
future bilateral and regional agreements with developing countries;
12. Asks the Commission to support disclosure by patent applicants of
the source and origin of inventions deriving from biological resources
and associated traditional knowledge found in developing countries with
a view to promoting the equitable sharing of the benefits and technology
derived from those resources by supplying countries;
13. Calls on the Commission to support "pool procurement strategies"
under Article 31(b) of the TRIPS Agreement and other strategies which
could be used by countries or groups of countries to provide greater
buying power and economies of scale in the production of generic
medicines at affordable prices and stimulate direct investment in local
production facilities within a region;
The EU, pushed particularly by Germany and France, recently said it
would file
> a complaint against Thailand for breaking the international agreement on
> compulsory licensing
14. Asks the Council to mandate the Commission to proactively support
the work of the Intergovernmental Working Group on Public Health,
Innovation and Intellectual Property (IGWG) at the World Health
Organization and to report regularly to the European Parliament on its
work;
15. Encourages pharmaceutical companies to pursue pricing alternatives
involving a high-volume, low-margin approach, which could enhance access
to medicines;
16. Recalls that counterfeiting of medicines is not a patent issue as
such; stresses that measures to tackle counterfeiting need to be taken
in the area of criminal enforcement (penal sanctions) and drug
regulation by reinforcing the regulatory capacity of the national
authorities and not by increasing levels of intellectual property
protection;
17. Calls on LDCs and other poor countries to take the necessary
measures to prevent medicines covered by compulsory licensing from
leaving the country and ensuring that the medicines go to the local
population in need;
18. Instructs its President to forward this resolution to the Council,
the Commission, the Governments of the Member States and ACP countries,
the WTO and the heads of The Joint United Nations Programme on HIV/AIDS
(UNAIDS), United Nations Development Programme (UNDP) and United Nations
Population Fund (UNFPA).
(1)
Texts Adopted, P6_TA(2007)0274.
(2)
Texts Adopted, P6_TA(2007)0204.
(3)
Texts Adopted, P6_TA(2006)0526.
(4)
OJ L 157, 9.6.2006, p. 1.
(5)
WT/MIN(01)/DEC/W/2, 14 November
2001.
(6)
OJ L 157, 30.4.2004, p. 45.
Corrected by OJ L 195, 2.6.2004,
p.16.
Le lundi 10 mars 2008 =E0 14:59 +0100, Alexandra HEUMBER a =E9crit :
> [ Converted text/html to text/plain ]
>
> EU to ask wTO to rule on Thailand's drug licensing
>
> The EU will likely ask the World Trade Organisation (WTO) to rule on
> Thailand's imposition of compulsory licensing on its drug-makers, but the
> Intellectual Property (IP) Department is not cowering.
>
> Published on March 10, 2008
>
> The Nation
>
>
>
> "Thailand should win the case if there's any petition. The case will also
be
> evidence that Thailand has not breached any international regulations for
our
> compulsory licensing," director-general Puangrat Asavapisit said
yesterday.
>
> The EU, pushed particularly by Germany and France, recently said it would
file
> a complaint against Thailand for breaking the international agreement on
> compulsory licensing.
>
> Puangrat insisted Thailand was committed to following the WTO's Trade
Related
> Intellectual Property regulations and had already negotiated prices with
> owners of drug patents.
>
> The department is also working hard to convince the US to upgrade
Thailand's
> trade status.
>
> In a last-ditch effort, it recently sent a report to the office of the US
> Trade Representative (USTR) underscoring Thailand's progress in protectin=
g
IP
> rights.
>
> Puangrat said the department was closely monitoring the USTR's
consideration
> of upgrading or downgrading Thailand's trade status this year.
>
> It expects the USTR not to include the compulsory-licensing issue in its
> analysis.
>
> The USTR will announce its annual review of trade partners' status next
month.
>
> "Thailand should be upgraded to the 'Watch List', because of our success
in
> suppressing IP abuses over the past year," she said.
>
> Thailand was downgraded last year to the "Priority Watch List", which is
for
> countries weak in safeguarding IP.
>
> Petchanet Pratruangkrai The Nation
> Alexandra Heumber
> EU Advocacy Liaison Officer
> M=E9decins Sans Fronti=E8res
> Access to Essential Medicines Campaign
> Rue Dupr=E9, 94. 1090 Brussels
> ++32 (0) 2 474 75 09 (Dir off)
> ++ 32 (0) 479 514 900 (Mob)
> ++ 32 (0) 2 474 75 75 (Fax)
>
> _______________________________________________
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> Ip-health@lists.essential.org
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