E-drug: Act Up-Paris on EU's paper at the TRIPS council
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[By now we know that AIDS activists use many words to present
their views on access to ARVs, and few E-druggers may have the
time to read it all. However, I thought this piece was worth
investing your time, as it presents the major problematic aspects of
the European Commission's "Draft Declaration on TRIPs and access
to affordable medicines" (issued 21 September 2001). You won't
be surprised that it is looong. HH]
AIDS medicines: the European Union must choose a side
Last September 19-21 in Geneva, the WTO's Council of TRIPs
(Trade-Related Intellectual Property) met to prepare next
November's World Trade Ministers' Conference in Doha, Qatar.
This meeting was seized by 52 developing countries as the
occasion to ask the WTO to declare in Doha that 'nothing in the
TRIPs Agreement prevents Member States from taking measures to
protect public health'. They want to be able to manufacture or
import generic health products without fear of trade sanctions or
economic pressures from the developed countries. The United
States, Japan, Canada, Switzerland and Australia are opposing this
proposal and striving to stifle it. Meanwhile, the European
Commission chooses to rely on abstruse language in order to avoid
the issues and needs clearly brought forward by developing
countries and to bring its support to the adverse position led by the
United States. International civil society has already had the
occasion to witness the way that the EU, under cover of providing
a so-called mediating ground, in truth does the US' work of ridding
developing countries' proposals from all concrete or effective
measures, as happened at the last Health Ministerial in May (see
pan-NGO press releases of the time).
Last September 18, Trade Commissioner Pascal Lamy restated that
the DG-Trade had entered 18 months earlier into a consultation
with civil society with a view to putting the European position in
adequation with poor countries' populations' needs. During these
18 months, over 5 million people without access to treatment died
of AIDS. Seeing the Commission's position at the WTO, it appears
perfectly clear that this consultation process was in truth a
masquerade. In practice, the Commission is continuing its policy of
blocked treatment access on the millions of people living with fatal
diseases in poor countries.
On October 4, the European Parliament adopted a resolution for the
Commission mandating that the EU promote the recognition, at the
international level, of developing countries' right to domestically
produce and market generic medicines aimed at treating major
epidemics, without regard for intellectual property-related costs.
The EuroParliament also deplores that 'countries which took steps
to implement safeguard clauses in the TRIPs Agreement suffered
pressures to abandon the related measures' and considers that 'the
Commission and the Union's Member States should defend [...]
developing countries' right to use all the safeguard clauses provided
in the WTO's TRIPs Agreement, in all the aspects provided in the
Agreement (compulsory licensing, parallel importation, essential
generic medicine production, Bolar provisions, etc) and if
unsufficient, should ask, at the WTO, an adaptation of the TRIPs
Agreement'.
In this context, it is unacceptable that the European Commission,
acting in contempt of Parliament and of its own consultation
process, continue to block access to treatment for people with fatal
diseases in poor countries
In Doha, the Trade Ministers of the world will ratify a declaration
which will set out the rules of international trade for the next few
years. In times when the annual tally of world treatable disease
deaths is shooting past the 10 million human beings mark, the
stakes are overwhelming. Affordable quality medication must be
produced and distributed throughout the developing world now,
without hindrance from economic pressures. The rules of the game
need to be changed. The European Union can no longer continue to
block access to treatment.
(Below, comments by Act Up-Paris on the European Union's
infamous WTO 'non-paper' of September 21, 2001).
Act Up-Paris comments on European Commission non-paper, "Draft
Declaration on TRIPs and access to affordable medicines",
distributed on the Septembre, 21.
"Ministers,
Recognizing that access to health care and medicines for all,
and especially the poorest populations of the globe, is one
of the major challenges for the global community and to its
sustainable development; Conscious that improving health and
combating poverty requires a mix of complementary social,
economic, and health policies and practices and is, therefore, the
common responsibility of many international organisations,
governments, non governmental organisations and private
actors; Acknowledging that accessible price is one of the
determinant factors of access to medicines, alongside efficient
infrastructure to distribute, deliver and monitor drug usage and
provide necessary information and education, and increased
research and development and mechanims to finance drug
purchases;"
- Indeed, accessible price is a determinant factor of access to
medicines. It is this regards which concerns the commission's
position at WTO and the council of TRIPS. As for the other
determinants of access such as infrastructures and finance
mechanisms, which are outside the WTO mandate, it is now time
for the Commission to implement the action plan that has been
passed in Parliament last year, and to overcome its failure to spend
the 23 billion euros sleeping in the European Development Fund. Let
us avoid obvious mistakes : R&D DOES NOT make medicines
accessible. It certainly causes for new medicines to become
available, however it has no incidence whatsoever on whether
medicines are or are not accessible for patients. That is the whole
point of developing countries' proposal to the TRIPs Council : drugs
into bodies =AD not drugs on the market.
"Recognizing that prices for medicines should adequately reflect
the differences in cost of living and purchasing power between
developed, developing and least developed countries; Welcoming
that interested parties continue their efforts to establish global
tiered pricing system for medicines in view of ensuring
sustainable supply of affordable medicines to the poorest;"
- In view of 'ensuring sustainable supply of affordable medicines to
the poorest', the Commission should not forget the fact that
effective tiered pricing depends on successful generic competition,
in the sense that mere discount negotiation with pharmaceutical
corporations is a mechanism unable in itself to sustainably
guarantee lowest possible prices for all lifesaving drugs.
"Recalling the mandate of the TRIPs Council that Members
would, within the TRIPs Council, work on "the interpretation and
application of the relevant provisions of the TRIPs Agreement
with a view to clarifying the flexibility to which Members are
entitled under the Agreement and the relationship between
the TRIPs Agreement and affordable access to medicines";"
- The Commission exhibits blindness to the criticality of the matters
under debate and the extent of global mobilization, by governments
and civil society alike, in choosing for a goal the discussion of
administrative procedures in a bureaucratic framework, when
expectations are on the level of the utmost urgency: results in
access to lifesaving drugs. The context for developing countries'
clear proposal that nothing hinder access to health comes in the
wake of 10,000 aids deaths in the world each day.
"Remaining strongly committed to the TRIPs Agreement and its
implementation; Considering that intellectual property rights
provide an essential stimulus for creativity and innovation, that
these rights need to be adequately protected in order to
encourage and secure investment in research and development
of new medicines, and particularly those targeted at the major
communicable diseases; Recognizing therefore that intellectual
property contributes to serve public health objectives globally;"
- On the topic of the value of intellectual property protection (IPP)
as incentive to R&D on the diseases of the poor, the Commission's
position in the TRIPs Council is in blatant contradiction with its
position in the Civil Society Consultation (CSC) : at the May 28
CSC meeting, Mr Jean-Charles Van Eckhaute, TRIPs expert in the
Commission's intellectual property department, stated that
intellectual property protection and market forces are unable to
provide R&D where there is no solvent market. Thus, this statement
on the innovation incentive seems completely outside of topic, and
can only be construed as extremely inopportune propaganda. On
contrary, the Commission should insist on the fact that unalleviated
implementation of intellectual property protection causes situations
of monopoly thereby excluding poor countries from access to
Western health innovations - a fact which is exemplified with the
fullest violence in the case of newest-generation, potent HIV/AIDS
drugs. Furthermore, in the strictest public health point of view, the
fact is that intellectual property imposes significant limitations to
drug development by preventing certain categories of technically
simple, patient-oriented innovations (such as CIPLA's once-a-day
triple therapy Triomune) which, due to IPP, remain only available to
a very few patients in a very few countries. Therefore, in this
context, there can be no justification for the Commission's
commitment to the TRIPs Agreement and its implementation, and
no need to recall it in this non-paper.
"Concerned about the lack of adequate research and
development on medicines for the prevention and treatment of
diseases predominantly affecting people in developing and
least-developed countries;"
- Concerned about lack of research on diseases of the poor, and
having recognized in the CSC that Intellectual Property Protection
can not generate research for the unsolvent, the Commission
should consider financial support to public research efforts in
developing countries.
"Recognizing that intellectual property is one of the factors
which have a bearing on the price of medicines; Confirming our
belief, that, in accordance with Article 7 of the TRIPs
Agreement, the protection and enforcement of intellectual
property rights should contribute to the promotion of
technological innovation and to the transfer and dissemination of
technology, to the mutual advantage of producers and users of
technological knowledge and in a manner conducive to social
and
economic welfare, and to a balance of rights and obligations;"
- The Commission is perfectly aware of the fact that poor countries
never received any technology transfer as agreed in the TRIPs
because these clauses were not binding. This is what the OAU
countries pointed out to Commissioner Lamy at the 2000 Trade
Ministerial Summit in Libreville. Thus, the Commission should
refrain from referring to technology transfer until European
commitments in that regard have become reality.
"Affirming that the TRIPs Agreement provides for the necessary
flexibility to allow WTO Members to determine how to strike that
balance between the respective interests, rights and obligations
of right holders and consumers, and in particular to implement an
intellectual property regime that is supportive to their public
health objectives;"
- Why then do HIV/aids drug copies remain unavailable in the vast
majority of aids-ridden poor countries ? Why then do 52 countries
ask for a clarification of the right under TRIPs to take measures to
protect public health, such as resort to drug copies ? And why is
the EC so reluctant to affirm in Doha that nothing in the Agreement
prevents countries from taking measures to protect public health ?
By this absurd affirmation the Commission not only ignores and
denies the point made by 52 Member States to the WTO and
several hundred civil society organizations, but also chooses a
policy which borders on the murderous, while 10,000 people die of
AIDS every day.
"Recognizing that compulsory licensing and parallel imports may
under circumstances be used as tools to ensure supply of
affordable medicines to populations which would otherwise not
benefit access to such medicines;"
- A this stage the Commission should say that compulsory licensing
and parallel imports have to, not 'may', be used to ensure supply of
affordable medicines to populations which would otherwise not
benefit access to such medicines. In the present situation the
Agreement isn't sufficient to unable poor countries to authorize
drug copies ; rather than paraphrasing the text of the agreement,
the Commission should specify that nothing in the TRIPs prevents
countries from using generic medicines.
"Taking note, in particular, of the fact that certain Members may
have very limited or non-existent industrial capacity as well as a
very small domestic market, making it in practice impossible to
make full use of the rights provided to these Members by Article
31 of the TRIPs Agreement;"
- The Commission restricts here the rights provided in Article 31 to
domestic use (whereas 31.k also provides for use for export),
which is an unduly narrow view of the Agreement. Furthermore, in
response to the fact that many least developed countries lack
industrial capacity, the Commission's duty is to implement
technology transfer and development support to a degree consistant
with needs. In particular, the Commission should respond to the
urgency of the current global health crises by supporting poor
countries in their efforts to avail themselves on the international
market of quality, affordable, generic medicines.
"Recalling the Preamble of the TRIPs Agreement, which, among
others, prescribes that measures and procedures to enforce
intellectual property rights should not themselves become
barriers to legitimate trade and recognizes the special needs of
the least-developed country Members in respect of maximum
flexibility in the domestic implementation of laws and regulations
in order to enable them to create a sound and viable
technological base;""MINISTERS DECLARE THAT
1. The TRIPs Agreement shall be implemented in a way as to
ensure access to affordable medicines for all in the context of
public health policies."
- If the EC sincerely thinks the TRIPs should be implemented as to
ensure access to affordable medicines for all, then it should affirm
that 'nothing in the TRIPs prevents Members from taking measures
to protect public health' as the 52 developing country Member
States are asking in their Doha declaration proposal.
"2. Each provision of the TRIPs Agreement should, in accordance
with Article 31 of the Vienna Convention on the Law of the
Treaties, be read in the light of its object and purpose as set out
in Articles 7 and 8 of the TRIPs Agreement."
- AIDS constitutes an unprecedented epidemic in scale, impact and
global spread. It is in this context that the most affected countries
feel that the Trade Ministerial must officially declare that nothing in
the TRIPs Agreement prevents countries from protecting public
health and access to health. How serious is it for the Commission
to come up with a proposal that the Trade Ministerial officially
declare that the TRIPs Agreement should be read as it already says
it should be read ?
"3. Article 31 of the TRIPs Agreement, which prescribes the
conditions under which Members can grant compulsory licenses,
leaves WTO Members the freedom to determine the grounds for
granting compulsory licenses, provided the terms and conditions
set out in the Agreement are met."
- As the Commission points out in the least direct manner, articles
7, 8 and 31 of the TRIPs are supposed to allow for public health
protection and public interest promotion, while enhancing
technology transfer. Yet what the AIDS epidemic so far is showing
is that greater intellectual property protection, which is supposed to
'contribute to the promotion of technological innovation and to the
transfer and dissemination of the technology, to the mutual
advantage of producers and users of technological knowledge and
in a manner conductive to social and economic welfare, and to
balance of rights and obligations', in practice is only conducive to
poor public health and acts as to block access to life-saving
medications for entire populations living in poor regions.
Article 8 offers that 'Members may, in formulating or amending
their laws and regulations, adopt measures necessary to protect
public health and nutrition, and to promote the public interest in
sections of vital importance to their socio-economic and
technological development'. However, in reality many Members
have faced intense lobby and considerable pressure both from
industry and most-developed countries so that they pass laws and
regulations excluding recourse to these TRIPs-compliant measures.
On top of this, in those few undeveloped countries where the
government resisted initial pressures and did pass legislation
allowing recourse to these measures, then the pressures redoubled
and concentrated on precluding the implementation of these
measures.
Likewise, article 31 theoretically permits the use of a
pharmaceutical patent's subject matter without the permission of
the IPR holder (compulsory licensing). In reality not even a single
compulsory license has yet been granted in a poor country in order
to remedy a blocked treatment access situation (through the local
production or the importation of cheaper generic medicines), while
the world's most developed countries routinely compulsory-license
IPRs to remedy blocked competition situations. The EC is perfectly
aware of this absurd, gross imbalance in the TRIPs Agreement and
its implementation. The Commission must recognize, and
emphasize, the fact that in reality articles 7, 8 and 31 of the TRIPs
Agreement do not satisfyingly permit the protection of public health
imperatives. Indeed, the inherent imbalance is such that the WTO's
most developed Member, the United States of America, remains in
perfect safety from dispute settlement procedures while itself in
gross violation of the Agreement (for instance, the US does not
proceed to the evaluation of the individual merit of each compulsory
license on a case-by-case basis, as the TRIPs mandates). For these
reasons, the WTO has to state clearly that health, as the most vital
form of public interest, must prevail against any particular interest
economic or other, and that nothing in the TRIPS agreement
prevents Members from protecting their population and from
promoting public health. Furthermore, the seriousness of the global
AIDS pandemic demands that coercive measures be adopted so
that WTO Members face sanctions should they abuse bilateral trade
diplomacy to impose death-causing legislation or practices. If the
WTO is unable to ensure that the safeguard provisions be
implemented wherever and whenever necessary, and more
generally that the TRIPs pose no threat to world health, then neither
TRIPS, nor WTO, should be maintained.
"4. Each compulsory license must be considered on its own
merits."
- If this is the Commission's profound concern, the EC, in the 6
years since the Agreement was signed, should have entered in
discussions with the United States to press them to change their
law and practices into accordance with this point, instead of
supporting the criminal US attitude towards poor countries.
"5. In the case of a national emergency or other circumstances
of extreme > urgency or in cases of public non-commercial use,
Members may, subject to Article 31 (b) of the TRIPs Agreement,
grant compulsory licenses without prior efforts on the part of the
user to obtain authorisation from the right holder. Epidemics of
life-threatening communicable diseases can qualify as situations
of 'national emergency' or as a 'circumstance of extreme
urgency' within the meaning of Article 31 (b) of the TRIPs
Agreement."
- Again the Commission proposes that the Trade Ministerial declare
that what is in the Agreement is in the Agreement. This would be
merely unserious if it didn't fall so extremely short of the stakes
involved with the global aids epidemic. What is the Commission's
point in paraphrasing Agreement safeguard provisions which are
unimplementable in practice, when this unimplementability is the
very reason why the debate has come to on the WTO table in the
first place ? In the absence of concrete, additional garantees from
the WTO that nothing in the Agreement prevents Members from
protecting public health, these paraphrasing proposals by the
Commission are only, and shockingly, pointless.
"6. The TRIPs Agreement leaves Members the freedom to
choose the exhaustion regime that best suits their intellectual
property objectives."
- Again the Commission chooses to reply to poor countries' need
for additional safeguards by restating Agreement safeguards. In the
absence of concrete, additional garantees from the WTO, these
paraphrasing proposals are pointless.
"7. Intellectual property rights are exhausted, within the meaning
of Article 6 of the TRIPs Agreement, when the goods to which
these intellectual property rights apply have been put on the
market by the right holder or with his /her consent."
- This careful formulation by the Commission doesn't say anything
about the issue, which is parallel importation, since the Commission
doesn't specify whether its proposed definition of IPR exhaustion
applies to the market of exportation or to the market of importation.
"8. Whatever the exhaustion regime chosen, Members will
consider all necessary measures to prevent that pharmaceuticals
imported under a tiered pricing scheme or supplied under
aid-schemes leave the market to where they are originally
destined or (re-)enter markets which are not eligible for lower
prices."
- Firstly, in terms of sustainable public health policy measures, drug
aid is only a very minor issue, which goes in sharp contradiction
with the degree of attention which the Commission gives it and
wishes the Ministerial to give it. Also, if one is intent on policing
drug aid, there are a great deal more worrying problems than
cross-market leakage. Policing drug aid calls first for sharp controls
to be imposed on the many abuses on the spirit and letter of the
relevant law by the proprietary pharmaceutical industry which are
vocally decried by the majority of involved NGOs and public health
experts ; it only incidentally calls for controls on corporate donation
trade. Secondly, concerning tiered-pricing and reimportation, there
is no historical precedent for preventing the exportation of legal
goods, while there are innumerable precedents for preventing
importation of illegal goods. Why does the Commission choose to
ignore the simple, tried-out way of illegal importation prevention, to
focus instead on the chimera of legal exportation prevention ?
"9. The obligation under Article 39.3 of the TRIPs Agreement to
protect test data against unfair commercial use and against
disclosure should not be interpreted in such a way as to weaken
or nullify Members' rights under other Articles of the TRIPs
Agreement, such as the possibility foreseen under Article 31
(b<) of the TRIPs Agreement to grant compulsory licenses
without making prior efforts to obtain authorization from the
right holder in the case of a national emergency or other
circumstances of extreme urgency or in cases of public
non-commercial use."
- This again falls short of spelling out the right of governments to
disclose original data to copy manufacturers. Also, the Commission
takes a surprisingly rest
rictive view of cases of disclosure when
solely considering disclosure from a drug regulatory agency to a
copy manufacturer, as opposed to disclosure from one drug
regulatory agency to another. Indeed, the problem with
pharmaceutical test data and AIDS is that most poor countries have
registered the HIV drugs on the simple basis of registration in the
US or Europe, that is to say, without having received the original
test data. The Agreement imposes test data protection against
commercial use, not against public use : the real issue thus is,
when will developed country governments disclose aids drug test
data to undeveloped country governments, so that they may assess
copy drug quality assurance data in full intelligence?
"10. Developed Members are urged to provide technical
assistance for the implementation by the least developed
countries of their obligations under the TRIPs Agreement, while
taking into account health concerns."
- Developed countries are falling over each other to assist poor
countries in implementing their IPP obligations under TRIPs, but
they have nothing to reply to the complaints of countries such as
Egypt or Mauritius about the fact that they have systematically
reneged on their own technology transfer commitments under TRIPs
(which represented when the Agreement was signed poor
countries' only incentive in accepting Western IPP standards). How
does the Commission intend to strengthen the TRIPs Agreement if it
takes part of an approach of TRIPs which instrumentalizes the
Agreement to force poor countries to stop copying Western IP
without concern for the millions annual deaths which ensue from
blocked access to copies, while at the same time systematically
reneging on their moral and legal duty to provide financial and
technical assistance to poor countries in protecting and providing
care for their populations? Instead of urging poor countries to
protect IPP, the Commission ought to make all haste implementing
the recently passed Programme for Action against AIDS,
Tuberculosis and Malaria, by supporting financially and technically
the manufacture, registration and distribution of medicines as well
as other aspects of comprehensive care for people with
communicable diseases.
"11. The TRIPs Council will call for closer co-ordination between
WTO, WIPO, and WHO."
- The TRIPs Council and WIPO need to let WHO do its job in peace ;
rather than coordinate with them, the TRIPs Council needs first to
recognize the primacy of health objectives over trade and the
imperative of protecting populations' interest rather than
corporations' interests.
"12. In view of the special needs and requirements of
least-developed country Members, their economic, financial and
administrative constraints, and their need for flexibility to create
a viable technological base, Members will, in due time positively
consider individual requests for extension of the transitional
period provided for their benefit under Article 66.1 of the TRIPs
Agreement."
- Extension of the transitional period partakes of the same
imperative as that of declaring officially that nothing in the TRIPs
Agreement prevents countries from taking measures to protect
public health : the primacy of public interest against private
interests, of human life over profits.
Gaelle Krikorian
Act Up-Paris
North/South Commission
Act Up-Paris
BP 287 - 75525 Paris cedex 11
Tel: 33 1 49 29 44 75
Port: 33 6 09 17 70 55
Fax: 33 1 48 06 16 74
E.mail: galk@compuserve.com
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