E-drug: WHO Exec Board on RDS/TRIPS - South African contribution
---------------------------------------------------------------------
dear E-druggers,
Some people have asked for a copy of the South African speech
during the Executive Board discussion on the Revised Drug Strategy.
kind regards
Ian Roberts
Special adviser to the Minister of Health
Cape Town
South Africa
Email: irobmoh@global.co.za
---------
Dr Brundtland, distinguished members of the Executive Board,
Colleagues, Ladies and Gentlemen, may I begin by expressing the
gratitude of my government at being afforded the opportunity to
address the Board on this very important issue.
I am Peter Goosen, Charge d� Affairs at the South African Permanent Mission.
What you may ask, is the reason for South Africa�s keen interest in this
issue?
The answer is quite simple,
Our constitution commits this government and all future South African
governments to providing universal access to quality health care, which by
definition includes the access to safe and affordable essential medicines.
This goal may be considered by some to be overly ambitious, but we believe
that it is achievable and as a government, we remain committed to this
ideal.
Secondly, we believe in solidarity in health. It is impossible to conceive
of a world that has stability but in which some populations are healthy and
others not. South Africa cannot have a healthy population while others
suffer ill health. The South African government is committed to working for
world-wide equity in health.
We are all familiar with the financial constraints which shape public sector
budgets but these difficulties are magnified when considered in the context
of developing countries like South Africa.
The cost of medicines constitutes about 20% of South Africa�s total health
costs as compared to an EU average of 10.5 %. There is also proof that
medicines are more expensive in developing countries in both relative and
absolute terms. As a result, many essential medicines are simply
unaffordable to the citizens of developing countries.
In an attempt to rationalise the use of our limited resources and to thereby
extend the reach of our health services, we embarked upon a review of our
drug policy in 1996. This review involved all stakeholders and was executed
with technical assistance from the Drug Action Program, resulting in the
finalisation of appropriate legislation in October 1997.
This legislation addresses a range of issues to ensure all South Africans
have access to safe and affordable medicines. The South African legislation
streamlined registration and regulation procedures, ensured transparent
acquisition and pricing procedures, secure and efficient methods of
distribution, generic substitution, rational prescribing and dispensing. In
addition to these accepted international norms, we have passed legislation
to enable South Africa to parallel import pharmaceuticals and to allow for
the issuing of non-exclusive compulsory licenses.
There have been subtle and not so subtle attempts to bring international
pressure to bear on the South African government in regard to this
legislation, and while we remain open to persuasion by rational arguments,
our commitment to the underlying principles that underpin our legislation is
unwavering.
Although this model legislation can not be enacted due to a legal challenge
by vested interests - let me be very clear about the South African
government�s position.
The clauses in question provide an enabling legal framework for two TRIP�s
compliant strategies aimed at making medicines more affordable namely:
a.. As a signatory to the TRIPS agreement the South African
government respects patents and patent law as required by this agreement
b.. The international exhaustion of patent rights is not
prohibited by the TRIPS agreement and does not violate patent rights.
Additionally parallel importation is practised within the European
Union and is enshrined in European law. The international exhaustion
of other intellectual property rights is well established in
jurisprudence in many countries.
c.. Compulsory licensing for local production is permitted by
the TRIPS agreement.
These strategies to ensure affordable medicines have also been presented as
possible policy options in an official WHO publication, Globalisation and
the Access to Drugs (WHO/DAP/98.9). These strategies were also validated by
the contributions of the experts from WIPO and WTO during at the meeting of
the Ad Hoc group. The official WHO publication, Globalisation and the Access
to Drugs (WHO/DAP/98.9) is an invaluable resource for persons interested in
pharmaceutical policy and indeed international health and trade policy. We
understand that the concerns expressed by WTO have been addressed in a
revised document and we therefore look forward to receiving the revised
publication.
Mr. Chairman, it is our contention that this resolution on the revised drug
strategy addresses certain crucial public health concerns in a clear and
unambiguous manner. It reaffirms the primacy of the public health principles
on which this organisation was founded, thereby offering a small but bright
beacon of hope in the uncertain and unpredictable globalise environment of
the 21st century. This resolution is in fact a strengthened version of the
original as now public health considerations are an issue, not only in
international trade agreements, but additionally in international financial
agreements. It is WHO�s clear role to protect public health needs at these
international forums. As such the revised drug strategy document has the
support and endorsement of the South African Government.
This resolution has much in common with our domestic legislation and given
South Africa�s international profile, as co-ordinator of the SADC health
sector and chair of the Non Aligned Movement, we feel a sense of pride and
vindication when goals and ideals, that we hold dear, find resonance,
acceptance and consensus at the international level in this manner.
Mr. Chairman, ladies and gentleman, we wish to join others in complimenting
Prof Giraud for the way in which he handled a very difficult meeting. His
report is an accurate but rather bland record of a very lively meeting and I
think that we all understand why this is so. We believe, however, that there
are crucial omissions from this report and humbly propose the inclusion of
the following elements as a means of enriching the document and correcting
any oversights:
a.. The decision by the World Health Assembly to refer this matter for
further negotiation needs to be recognised as a rare and extremely important
development which raises important questions as to the future role of the
Executive Board. This important element appears to have been overlooked in
the preparation of the report and of the background documents to agenda item
4.
b.. If the "Ad Hoc Group" mechanism is to be promoted as a consensus
building or deadlock breaking mechanism for the future - and we agree that
it holds some promise in this regard - sufficient consultation should go
into defining a formal mechanism to ensure a democratic and transparent
process is followed
c.. We strongly support the view that many issues that surround
affordable, equitable and accessible medicines need to be further discussed.
In Africa, less than 50% of the people have access to medicines. This is
totally unacceptable in a world that should be showing solidarity in
healthcare.
As always, the new democratic government of South Africa will add value to
these discussions by its active participation.
Thank you.
---(end)
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.