Ladies and Gentlemen,
It is a pleasure for me to make this keynote speech at the annual
conference of the International Generic Pharmaceutical Alliance.
Although your interests are admittedly much broader, my intervention
this morning will focus on the interface between trade-related
intellectual property rights and access to medicines — an issue of
direct relevance to your industry.
My starting point today is the WTO's core mission of opening trade,
which intersects with health in many ways, none of which can be treated
in an isolated manner.
International trade helps improve the health conditions of many people
both indirectly — through increase in incomes — and directly, through
imports of health-related products or through health-related services.
Public health is a key value whose importance is recognized in all WTO
Agreements, starting as far back as 1947 with the GATT that confirmed
the right of WTO members to give priority to health policies even if it
leads to trade restrictions. This was reconfirmed in 1995 in the then
new agreements on trade in services (GATS) and on intellectual property
Intellectual property rights, as other matters covered by the WTO
Agreements, constitute only one piece of a much bigger puzzle that
determines the level of access to medicines by patients in a given
Other pertinent factors include the existing infrastructure in a country
and its national health system in general, or the transparency and
efficiency of the procurement regime. Recently attention has also
focused on existing tariffs on imported healthcare products whose
reduction or even elimination could facilitate their accessibility. For
an objective evaluation of the situation, we thus need to pay attention
to various factors, as well as to the relevant domestic policies put in
place by governments.
Among these factors, the issue of TRIPS and public health is certainly
one of the most emotive and, consequently, frequently debated issues.
As recognized by the Doha Declaration on the TRIPS Agreement and Public
Health, and reiterated by several World Health Organisation Resolutions,
we are talking here about a delicate balancing act between guaranteeing
the protection of intellectual property rights as an important incentive
for the development of new medicines on the one hand, and addressing
concerns about the potential impact on prices for such medicines on the
I am happy to note that the European Generic Medicines Association's
recent report on patent-related barriers is drafted along similar lines.
It recognizes the role of patents to promote innovation in the
pharmaceutical sector and to recoup R&D investment, but also calls for
generic competition to be available immediately after patent expiry.
That the debate on intellectual property and public health is sui
generis has been explicitly recognised by WTO members when they
confirmed that medicines are not just an ordinary tradable commodity.
The 2001 Doha Declaration on the TRIPS Agreement and Public Health
backed the carefully negotiated balance of rights and obligations in the
TRIPS Agreement. It provided a number of important confirmations and
clarifications, including the right of WTO members to grant compulsory
licences, the freedom to determine the grounds for such licences and the
definition of national emergencies, as well as the freedom to adopt the
appropriate exhaustion regime without challenge.
Since its adoption in 2001, there have been concrete examples of the use
of the flexibilities incorporated in the TRIPS Agreement at country
level, including allowing parallel imports, defining patentability
criteria, and permitting exceptions to patent rights, such as the
regulatory review exception.
The WTO dispute settlement mechanism has also confirmed these
flexibilities. But it is also true that not every WTO member has yet
taken the necessary steps at national level to avail itself of the
Let me now turn to the Paragraph 6 System, established under the General
Council Decision of August 2003. This system was used for the first time
in September 2008 to ship generic medicines from Canada to treat
HIV/AIDS patients in Rwanda.
At the same time we have seen criticism expressed on the cumbersome and
complex nature of this mechanism which would “hardly ever work” in the
words of some critics.
It is precisely to address these kind of situations that WTO members
agreed to subject this system to periodic review. I would note that WTO
members did not raise concerns during the last annual review of the
operation of the system and instead, led by the African Group,
reaffirmed the system two years after its adoption.
This may be linked to the fact that the use of the Paragraph 6 System is
confined to specific and well-defined circumstances, thus keeping the
burden on potential users with fewer administrative resources to a
minimum. In fact this system constitutes an additional flexibility to
many that are already in the TRIPS Agreement, including as recognized
and clarified in the Doha Declaration on the TRIPS Agreement and Public
In any event, the system is far from being the sole solution to problems
encountered in the public health sector. But this does not mean that we
should have a blind faith in its success. Just like any WTO agreement,
the Paragraph 6 System should be periodically reviewed and lessons drawn
from these evaluations so that the WTO can continue its effort to make
it work as a contribution among others to enhancing access to medicines.
I would like to briefly add the WTO's perspective to three issues which
are often debated these days outside the TRIPS Council and which I know
are on your mind.
First, as regards undisclosed information, its protection clearly forms
part of the obligations under the TRIPS Agreement. Thus, test data
submitted to obtain the marketing approval for pharmaceutical products
are, under certain circumstances, to be protected both against unfair
commercial use and disclosure. This has led to questions as to how such
protection must be provided, an issue which is not explicitly addressed
by the TRIPS Agreement.
While there has been some debate as part of the preparatory process
leading to the adoption of the Doha Declaration in 2001, there is as yet
no confirmed WTO jurisprudence or authoritative guidance on this
question, other than that the application of the pro-public health
interpretation in the Doha Declaration clearly covers the TRIPS
Agreement as a whole.
As regards the more general concern often expressed with regard to
“TRIPS plus” provisions in FTAs, certain of the provisions concerned may
potentially have a bearing on access to medicines, as well as on the
generic industry. At the same time, the developed country members
participating in such FTAs have more recently confirmed their commitment
to access to medicines for all, stating that such provisions are not
meant to affect the ability of the parties to take measures to protect
public health. The WTO's role in all this remains limited: the TRIPS
Agreement tells us that members are free to adopt higher standards of
protection. Therefore, we can at best monitor the content of such FTAs
and offer a platform for discussion, as we do, for example in the trade
policy reviews of our members. Any more ambitious initiative has to come
from the membership, the WTO being a member-driven organization.
I would finally like to briefly take up the combat against counterfeit
medicines which is being intensively debated these days. We certainly
all share the common goal to keep counterfeit medicines out of the
market, as they can have serious public health consequences.
I believe we also concur in recognizing that the effective enforcement
of intellectual property rights, in particular trademarks, constitutes a
powerful tool to combat counterfeit medicines.
At the same time, I have noticed the concerns expressed by some of you
about an overly extensive interpretation of the term “counterfeiting”,
potentially leading to confusion with cases of ordinary patent
infringement and thus impeding generic competition.
Those issues are currently not debated in the
TRIPS Council. But I can safely say here that the TRIPS Agreement gives
a clear meaning to the term “counterfeiting”, linking it directly to
trademarks. I am convinced that we can all join forces to continue the
fight against counterfeit medicines through the appropriate means,
including through the protection and enforcement of intellectual
property rights as provided for in the TRIPS Agreement.
To conclude, I would like to share with you a cautiously optimistic
assessment of the current state of play in the field of access to
medicines. Important steps have been taken in the WTO and elsewhere
since the adoption of the Doha Declaration in 2001. Access to medicines
has been improved through a major reduction of prices, enhanced
international funding, a greater recognition of the need to find a
balance within the intellectual property system, as well as the use of
some of the TRIPS flexibilities by certain WTO members.
But although the situation has improved over the last couple of years,
the continuous and constructive engagement of all relevant stakeholders
would still be required. This clearly includes the generic industry,
which is playing a vital role, as underlined by its important market
share in many countries. Only joint efforts will lead to further
improvements in access to medicines for patients around the world.
That's the common endeavour that, I believe, unites us all.
I wish you a rich debate over the next few days. Thank you for your
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