E-DRUG: DOH and UNAIDS Media release
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[for completeness sake, DOH, WHO, UNAIDS and PMA media releases on the court case. NN]
[DOH]
Source: Ministry of Health <www.gov.za>
Title: Tshabalala-Msimang: Drug companies withdraw case against SA Government
DRUG COMPANIES WITHDRAW CASE AGAINST SA GOVERNMENT
Earlier today in the Pretoria High Court 38 pharmaceutical companies and the
Pharmaceutical Manufacturers' Association announced that they were withdrawing
from the court action that was intended to strike down major provisions of
our Medicines and Related Substances Control Amendment Act of 1997.
We are pleased that the pharmaceutical industry has finally recognised both
the legitimacy of our struggle, as South Africans, for affordable health
care and the genuineness of our respect for the international trade treaties
that we are party to. It is a pity that the pharmaceutical industry could
not be persuaded to take this view three years ago, when the South African
Government offered to work constructively with it to address concerns about
the new law. The industry's response at the time was to take us to court
in a costly and ultimately fruitless exercise.
We regard today's settlement as a victory in the sense that it unfreezes
our law and restores to us the power to pursue policies that we believe are
critical to securing medicines at affordable rates and exercising wise
control over them. We have undertaken to include pharmaceutical manufacturers
in such initiatives, where appropriate, and we fully intend to pursue this
course of action.
The settlement that we have announced today is the product of a large number
of people in many countries. It is the work of countless South Africans who
stood up in an expression of national unity and clearly supported the
approach of government. It is the achievement of organisations, activists
and governments elsewhere in Africa and on other continents who recognised
our particular battle as part of a broader movement for justice in health care.
While the South African Government's drug policy was driven mainly by domestic
factors, we never lost sight of the international dimension and we hope
our experience has contributed in some way to the larger debate on access to
affordable health care for developing countries and for the poor in wealthier
nations.
We do not delude ourselves that the end of the court case is the end of our
struggle for access to affordable medicines. In reality, we are only at the
start of a long and arduous journey and this law is merely a vehicle. Difficult
decisions about contending health care priorities lie ahead.
The Medicines Act was enacted but not promulgated when the court action was
launched three years ago. Government will now go ahead and promulgate the
law and within a few weeks draft regulations relating to various aspects of
the Act will be published for public comment.
Certain aspects of the Act -- such as the prohibition on sampling and the
provision of incentives and bonuses by the industry -- will kick in
automatically with promulgation.
In addition, we will move speedily to:
* Set up the Pricing Committee whose job will include the gathering of
pharmaceutical intelligence and advising the Minister on a transparent
pricing system for medicines.
* Activate the system of generic substitution, which will have major
benefits for consumers in the private health care sector -- and especially
medical schemes.
In due course we will reconstitute the Medicines Control Council in line
with the Act.
We will continue to engage the pharmaceutical industry -- to consult them
and to challenge them, as appropriate -- in the local context and in the
international arena. There is a growing realisation internationally that we
cannot hope to make a dent on the major public health problems of developing
countries without concentrating all available resources. This demands a new
style of commitment from some parties and it certainly demands that we have
the courage to venture into new partnerships
The South African Government is proposing, as a start, to set up a joint
working group with the pharmaceutical industry in order to consult on and
consider broader issues in the area of health care. Early in May I will
invite the executives of all locally represented pharmaceutical companies
to meet me to discuss a framework for an effective working relationship.
My intention is that there should be a mechanism for regular interaction.
The resolution of this court case only confirms our view that international
markets, which play an increasingly important role in all our lives, have
no inbuilt conscience. But governments and ordinary people acting
collectively have a precious responsibility to make the huge companies that
dominate the markets accountable for how they respond to the most critical
issues of our times.
Dr Manto Tshabalala-Msimang
Minister of Health, Republic of South Africa
19 April 2001
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[WHO]
WHO STATEMENT ON OUTCOME OF SOUTH AFRICAN COURT CASE
1. The World Health Organization (WHO) welcomes the resolution of the court
case in South Africa over the 1997 Medicines Act 90. Since 1996, WHO has
worked with the Government of South Africa to put into place a National
Drug Policy to ensure "an adequate and reliable supply of safe, cost-effective
drugs of acceptable quality to all citizens of South Africa and the rational
use of drugs by prescribers, dispensers and consumers".
2. Resolution of the court case should now allow the Government of South
Africa, NGOs, and the companies themselves to invest their energies in
implementing key elements of the National Drug Policy and Medicines Act,
including generic substitution, greater competition in public drug procurement,
improved drug quality, and more rational use of medicines.
3. By shifting the focus to concrete action, WHO is confident that equitable
access to essential medicines can be expanded and vital HIV-related medicines
can in future be made available to all South Africans who need them. WHO is
prepared to assist the Government of South Africa in this process.
4. Expanding access to essential medicines - including HIV-related medicines -
requires three critical elements:
First, the opportunity which now exists for achieving the lowest
possible prices for essential medicines must actually lead to prices which are
sustainably and dependably lower.
Second, funding for essential medicines needs to be substantially
increased. This means more domestic funding as well as more international
funding. Especially for HIV/AIDS, any additional funding must ensure both
adequate support for prevention activities as well as improved care and
treatment.
Third, commitments and actions to build reliable healthcare and
supply systems are needed. Successful examples of effective healthcare
programmes and reliable supply systems already exist in South Africa and
elsewhere in Africa. These successes need to underpin and inspire development
of better health systems throughout Africa.
5. WHO also hopes that resolution of the case will be a step forward in
developing a common understanding of how World Trade Organization (WTO)
agreements can be implemented in ways which can help promote pubic health
goals.
Enquiries:
Dr Welile Shasha: Head of WHO South Africa: Tel: +27 12 338-5204 or +27 82 553 5197
Dr Jonathan Quick: Director, Essential Drugs and Medicines Policy: Tel: +41 22 791 4443
Dr Wilbert Bannenberg: WHO Technical Adviser on Pharmaceuticals: Tel: +27 82 575 6249
Greer van Zyl: WHO Health Information Officer Tel: +27 12 338-5219 or +27 82 375 8551
Gregory Hartl, WHO Spokesperson, Geneva, Tel: +41 22 791 4458
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[UNAIDS]
UNAIDS welcomes outcome of South African court case
Press Statement
Geneva, 19 April 2001 - UNAIDS welcomes the withdrawal by 39
pharmaceutical companies and associations of their legal case
before the High Court of South Africa. The case challenged
provisions of the Medicines and Related Substances Control
Amendment Act of 1997, whose intent UNAIDS has consistently
supported. The Act's intent is to operationalize key elements of the
National Drug Policy, including generic substitution, greater
competition in public drug procurement, improved drug quality, and
more rational use of medicines.
UNAIDS further welcomes the decision by the Ministry of Health to
create a joint working group with the pharmaceutical industry to
examine broader public health issues.
At the same time, UNAIDS believes that the adjournment of the
court case will allow South Africa to concentrate on concrete
implementation of existing legislation and policy and help make
essential HIV-related medicines available widely. UNAIDS notes,
however, that expanded access to drugs will yield significant
benefits only if certain preconditions are met: that prices are
lowered and their lower level maintained, that increased resources
for prevention and care are forthcoming both domestically and
internationally, and that broad commitments are made to improve
health infrastructure throughout Africa.
UNAIDS trusts that resolution of this case will encourage broader
implementation of World Trade Organization (WTO) agreements
and recommends that countries include in their national legislation
the possibility to use the safeguards, as permitted by the
Agreement of Trade Related Aspects of Intellectual Property Rights
(TRIPS).
For more information, please contact Anne Winter, UNAIDS,
Geneva, (+41 22) 791 4577, Dominique de Santis, UNAIDS,
Geneva, (+41 22) 791 4509 or Andrew Shih, UNAIDS, New York, (+
1 212) 584 5024.
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[PMA]
MEDIA RELEASE: INDUSTRY WELCOMES SETTLEMENT
OF SA COURT CASE AND PARTNERSHIP WITH GOVERNMENT
EMBARGO: IMMEDIATE
The Pharmaceutical Manufacturers' Association of SA (PMA),
today, is pleased to announce that the government of South Africa
and its members have reached a mutually satisfactory settlement
of their three year old law suit involving certain provisions of the
1997 Medicines and Related Substances Control Amendment Act.
The negotiated settlement which enabled the PMA and its
members to withdraw the court case follows Government's
commitment to adhere to its international obligations including the
Agreement of Trade Related Aspects of Intellectual Property Rights
(TRIPS) - an international agreement safeguarding patent rights and
other intellectual property rights. More specifically government has
undertaken to include the industry in the drafting and finalisation of
regulations that will give effect to the law.
These undertakings premise the basis of a relationship in which the
industry looks forward to partnering government in their efforts to
extend affordable, quality and sustainable medicine and healthcare
to all.
PMA believes that the outcome of this mutually agreed settlement -
which enjoys the unanimous support of the PMA and all its
members - best serves the interests of all South Africans.
FOR FURTHER INFORMATION PLEASE CONTACT:
Mirryena Deeb on 083 409 7505
Ericka Pinto on 011�805 5100
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