[Ip-health] TAC 13 March 2001: Questions & Answers and Letter to President
Alan Story
Alan Story" <a.c.story@ukc.ac.uk
Thu, 15 Mar 2001 11:58:40 -0000
I want to make a couple of comments on pt. 16 in your clear and
comprehensive backgrounder to " the case." TAC writes:
16) Is TAC against patents?
TAC does not stand against patents. We are against the abuse of patents.
When millions of lives are threatened because pharmaceutical companies
charge exorbitant prices on their medicines, then patents are being
abused. Clearly there is a need for patent law, in particular TRIPS, to be
reformed.
1) On the one hand, I can certainly appreciate why TAC has taken this
position of not being "against patents." What I would be interested in is
some more detail/explication of what reforms, precisely, you might have in
mind. Certainly one possibility is a different approach to patentability in
Article 27 of TRIPS and calling for a clear statement that countries do not
have to agree that pharmaceuticals must be patented and instead can
specifically
be exclude them from patentability. Deciding on what can and cannot be
patented is essentially a question of line drawing and
social/political/economic regulation; no
invention (product or process) must, naturally, be patentable. For example,
we would all recoil from any suggestion that gravity should be
patentable; what a world we would have if we had to pay a licence
fee to use the idea of gravity. Similarly, many people are questioning
whether human genes should be patentable. And in UK, the government
yesterday
reaffirmed its position that neither computer software nor business methods
should be patentable...while in the U.S., both are patentable and, in the
eyes of at least some critics (e.g. see the work of Richard Stallman) should
not be. In the light of this US/UK "disharmony" about what should and should
not be patentable, can you imagine the ruckus that would break out if the
U.S. took the UK to the WTO because it does not allow software patents or
business method patents. Article 27 states that "patents shall be available
for any inventions, whether products or processes, in all fields of
technology"...but it would be a strange interpretation indeed of Article 27
if the US could force the UK to make software or business methods
patentable.
So one clear reform/ slogan/idea to mobilise around would be " no national
government should be required to patent pharmaceuticals. " Those countries
that want to allow patenting can do so...and I can well imagine that it
would be quite a struggle for our colleagues in the U.S. to challenge
existing U.S. laws and existing U.S. views on pharmaceutical patents and
health, that is, it is the one "major" country in the world without a
comprehensive public health insurance system ( I believe, when I last lived
in the U.S., about 40 million Americans had no health insurance) and it is
the country with the most profit-driven /commodified health care system in
the world. But other countries might take a different views on health care
and patenting drugs ....and until TRIPS came along, many countries did not
permit pharm. patents. They might do so again...and this would be a reform
worth fighting for.
2) In the same vein--and I will keep this point shorter---I think we need to
challenge the paradigm that, without patents on pharmaceuticals,
pharmaceutical research and the development of new drugs would cease. As one
leading patent scholar wrote 50 years ago, "if national patent laws did not
exist, it would be difficult to make a conclusive case for introducing them"
and when we see all of the skulduggery and abusive profit-taking involved in
the current pharmaceutical scene, e.g. lots of R&D money for viagra, pennies
for anti-malarial drugs...and the other points TAC, OXFAM, MSF and others
have raised, the old paradigm is daily being revealed as having no clothes.
There are well-thought out alternatives to the patent system (e.g.
Goldhaber, Reinventing Technology, 1986), many well-thought critiques ( e.g.
the work of Arnold Plant and others) ... and I think further
discussions/debates we would be fruitful on this point. As long as we keep
accepting the view that it "the present patent system must stay in place and
not be challenged OR progress stops," the basic message from the drug
companies, we will keep within their parameters and only be able to do the
most minimal of tinkering. Remember the reply of Jonas Salk, inventor of the
"Salk" polio vaccine which did so much to reduce the spread of polio, the
"AIDS of the 1950''s" , when he was asked whether he would be applying for a
patent: "There is no patent; Could you patent the sun?" ( See It Now, 12
April 1955).
Cheers and in solidarity,
Alan Story
Lecturer in IP Law
Kent Law School
Canterbury , UK.
. This article answers some of them. It
> includes a short glossary of legal terms.
>
> 2. Letter to the South African President, Minister of Health and all
> Members of Parliament, concerning the development of a treatment plan and
> the declaration of a health emergency.
>
> ###
>
> Friends of the Court: Questions and Answers
>
> Important victories in the fight for access to treatment have occurred in
> the last week. The Treatment Action Campaign (TAC) was admitted as a
> friend of the court (amicus curiae) on 6 March in the much publicised case
> between multinational pharmaceutical companies and the South African
> Government. In addition, the international day of action called by TAC for
> 5 March was a resounding success. Around the world people mobilised
> demanding that the drug companies withdraw their legal action. The media
> gave full coverage and the court case captured headlines in most major
> newspapers and news broadcasts. Around the world, people hold the
> multinational pharmaceutical industry responsible for a large share of the
> blame for millions of unnecessary deaths. As a result of this pressure,
> drug company, Merck, announced a substantial drop in the price of its two
> anti-retroviral medicines. Furthermore, the Pfizer donation to the South
> African government, with all the problems accompanying it, has finally
> come through. This was a direct result of activist pressure.
>
> We have put together a glossary and a list of questions and answers
> regarding recent events.
>
> Glossary
>
> Trade Related Aspects of Intellectual Property Rights (TRIPS)
> This is a World Trade Organisation (WTO) agreement to
> which South Africa is a signatory. It defines the minimum
> standards to which intellectual property law of the member
> countries of the WTO must conform.
>
> Voluntary License
> This is where a patent holding
> drug company gives a manufacturer a license to
> produce the generic version of the patented medicine.
> This hardly ever happens.
>
> Compulsory License
> This is an order by a court or an administrative body
> to one or more manufacturers to produce and distribute a generic
> version of a patented medicine. It is compulsory
> because it takes place without the permission
> of the patent holder.
>
> Friend of the Court
> TAC is a friend of the court in the case between the government
> and the pharmaceutical companies. This means TAC may submit
> evidence and argument before the court. Although TAC takes an
> independent position, in this case we support the legislation and the
> government's desire to make all medicines affordable.
>
> Parallel Import
> This is when a patented medicine is bought from another country,
> usually at a lower price from the same producer. This is possible
because
> drug companies
> sell their medicines at different prices in different countries.
> Note that a parallel import does not refer to buying a generic
> version of a medicine, but to a lower-priced patented medicine.
>
> Patents Act
> This is the South African law relating to patents. It was passed
> in 1978 and amended in 1997 to make it TRIPS compliant.
>
>
> Question and Answers
>
> 1 What is the name of the law being contested between the South African
> Government and the pharmaceutical companies?
>
> Medicines and Related Substances Control Amendment Act No 90 of 1997, or
> just the Medicines Act for short.
>
> 2 What provisions for making medicines more affordable does the Medicines
> Act introduce?
>
> The act introduces three important provisions.
>
> * It makes provisions for parallel importation.
>
> * It establishes a pricing committee with the power to set prices of
> medicines.
>
> * It enforces generic substitution of off-patent medicines. This means
> that pharmacists must dispense cheaper, bio-equivalent, generic medicines
> that are not under patent, unless there are exceptional reasons for not
> doing so.
>
> 3 Are these provisions important?
>
> Yes, they establish a legal framework to reduce medicine costs, not only
> during a crisis, but on a long-term basis.
>
> The generic substitution provision will curb a practice that enriches
> brand-name producers and dispensers, at the patient's expense. A common
> example that most people will identify with is Panado. Few people are
> aware that generic versions of paracetamol are sold for 25% (or less) of
> the price of Panado. The same applies to cotrimoxazole, an essential
> medicine for preventing and treating opportunistic infections in people
> with HIV. Most pharmacists sell patients the brand-name version of
> cotrimoxazole, called bactrim. However, there are cheaper, generic
> versions available such as Purbac.
>
> 4 Does South African law allow for compulsory licenses?
>
> There are provisions for compulsory licenses in the Patents Act of 1978.
> The government should immediately request voluntary licenses from the
> patent holders of opportunistic infection and anti-retroviral medicines.
> This is the first step towards obtaining compulsory licenses.
>
> 5 What is the advantage of TAC being allowed to be a "friend of the
court"?
>
> The pharmaceutical companies have enormous resources. It is by no means a
> formality that the government will win. By joining the court case, TAC has
> presented argument against the drug companies that will show that drug
> company profiteering is a major obstacle to access. TAC brings to the
> court a perspective the government cannot, i.e. the testimony of ordinary
> South Africans regarding the cost of medicines, with particular emphasis
> on the HIV/AIDS epidemic. The government agreed to let TAC join because
> together there is a greater chance of beating the pharmaceutical
> companies. Furthermore, TAC's testimony has exposed the disgraceful
> practices of the pharmaceutical companies at a legal level. The drug
> companies are now on the defensive. It will be difficult for them to
> continue the court case without divulging information that they are
> usually reluctant to give out, i.e. their pricing data and practices.
>
> 6 But surely by joining the case, TAC has caused a 6 week delay in its
> outcome?
>
> The postponement is an indulgence that the judge has allowed the drug
> companies. TAC warned of its intentions to join the case on 26 January.
> The drug companies have had since 16 February to respond to TAC's
> arguments. Arguing that TAC's entry into the case delays the outcome of
> the case and, therefore, access to medicine, is akin to the logic of
> stating that the drug companies should have been presented with easier
> arguments to counter, so that the case could terminate quicker.
>
> Here is a summary of the advantages of TAC joining the case:
>
> * the chances of the drug companies losing the case have substantially
> increased
>
> * affordability of treatment within the context of HIV/AIDS is now part of
> the court case and cannot be ignored by the pharmaceutical companies or
> government
>
> * the chances that the judgement of the case will set an important legal
> precedent for poor countries in health care crises have substantially
> increased
>
> * the public mobilisation and negative publicity for the pharmaceutical
> companies generated by TAC calling for an international day of action and
> joining the case could not have been achieved otherwise.
>
> * generic manufacturer, CIPLA, used the court case, including TAC's
> testimony therein, to support their application for compulsory licenses
> two days after the court case began; another Indian generic manuafacturer,
> Hetra supported by Aspen Pharmacare (South Africa's largest generic
> manufacturer) has offered the lowest price for generic anti-retrovirals;
>
> * multinational pharmaceutical company, Merck, substantially dropped the
> prices of their anti-retroviral medicines a few days after the trial in
> order to relieve themselves of some of the pressure.
>
> 7 Will the pharmaceutical companies lose the court case?
>
> The pharmaceutical companies have enormous resources. They can hire the
> best lawyers and spend huge amounts of money slowing down the judicial
> process. There is no guarantee that the court case will be won by the
> state.
>
> 8 TAC has previously had an adversarial relationship with the SA
> government. Has this now changed?
>
> TAC is an independent social movement. We oppose the government when
> necessary and we support it when necessary. Our objective is the
> provision of affordable and good quality medicines for people with
> HIV/AIDS. Many of the government's policies, actions and inaction towards
> tackling the HIV/AIDS epidemic have been disgraceful. We have -- and will
> continue -- to criticise the government for this. However, the Medicines
> Act is an important law that will establish a legal framework for bringing
> down the prices of medicines. TAC, therefore, will support the government
> in trying to get it enacted.
>
> 9 Are the courts an appropriate place to conduct the fight for affordable
> treatment?
>
> Yes. Under the Apartheid government, the courts, aided by racist
> legislation, frustrated justice. Even then, we used the courts to expose
> inequality, torture and systemic violence. The new constitution, however,
> has made the courts a place where justice and equal rights can be
> enforced. This is not automatic but the current legal system is
> infinitely more advantageous to poor people. The fight for affordable
> treatment has to be conducted both through mass mobilisation and in the
> court rooms.
>
> 10 What is TRIPS and what is the South African government's obligation to
> TRIPS?
>
> The WTO TRIPS agreement sets a minimum standard that laws within member
> countries must follow. South African law is considered TRIPS-plus. This
> means that it gives stronger protection to intellectual property rights
> than TRIPS demands. The pharmaceutical companies are claiming that the
> Medicines Act is not TRIPS compliant. TAC, the South African, Dutch and
> German governments, the WHO, the ICFTU, the AFLCIO and many others firmly
> believe that it is. A law can be disallowed if it is found that it is not
> compliant with South Africa's international treaty agreements or the
> Constitution.
>
> TRIPS is a notoriously complicated, ambiguous legal document. It is a
> poorly drafted compromise of various interests, but mainly those of big
> business. There is clearly a need, especially by developing countries, to
> push for TRIPS and the WTO to be reformed. Currently it is too favourable
> to big business at the expense of consumers and start-up businesses,
> particularly in poor countries. However, we believe that the needs for
> people with HIV/AIDS can probably be met within the current agreement,
> albeit not without enormous legal costs and wrangling.
>
> 11 Does the government need to declare the HIV/AIDS epidemic a state of
> emergency?
>
> See TAC's statement on this below.
>
> 12 Will the Medicines Act hurt South African business?
>
> No. The HIV/AIDS epidemic threatens South Africa's social and economic
> fabric. South African Business, for ethical reasons, but also because it
> is in their interests should support the Medicines Act. Furthermore, the
> strengthening of the local generic pharmaceutical industry would also
> benefit the economy. Nevertheless, big business has been shamefully
> silent. South Africa's biggest institutions, holding companies, mining
> houses and life insurance firms, as well as medical aids, have a duty to
> openly support the government and to condemn the Pharmaceutical
> Manufacturers Association. SACOB are usually quick to criticise government
> when they perceive the slightest threat to their members. Their silence on
> this critical issue is unacceptable. In contrast, the unions, Cosatu,
> Nactu and Fedusa, have made a firm commitment to supporting the government
> in the court case.
>
> 13 What has been the US government's stance on the court case?
>
> The US government until recently supported the pharmaceutical industry.
> South Africa was placed on the US 301 Trade Watch List. Trade sanctions
> were threatened and AID was suspended. As a result of activist pressure,
> the US government backed down. Nevertheless it is critical for activists
> to put more pressure on the US government and to demand that the
> pharmaceutical companies withdraw their court action. The same applies to
> European governments. The German and Dutch governments are to be commended
> for openly supporting the South African government in the court case.
>
> 14 What has been the stance of the World Health Organisation (WHO)?
>
> Shortly after the court case began the WHO issued a statement of support
> for the South African government. The next day they retracted their
> support. If the WHO is truly committed to improving health-care they
> should not be taking a neutral stand on this issue. TAC calls on the WHO
> to openly support the South African government in the court case.
>
> 15 Do other poor countries stand to benefit from the court case?
>
> Yes. The court case has highlighted the disparate situation between
> treatment access in rich countries and poor countries. The international
> day of action highlighted the need for countries like Brazil, India, South
> Africa, Philippines and Thailand to form a strategic alliance with the
> power to reform TRIPS and other international legal agreements that are
> heavily weighted in favour of the United States and Western Europe.
> Furthermore, the development of a strong generic pharmaceutical industry
> throughout these countries will increase the chances of providing
> affordable treatment to other poor countries.
>
> 16 Is TAC against patents?
>
> TAC does not stand against patents. We are against the abuse of patents.
> When millions of lives are threatened because pharmaceutical companies
> charge exorbitant prices on their medicines, then patents are being
> abused. Clearly there is a need for patent law, in particular TRIPS, to be
> reformed.
>
> 17 What other barriers are their to access to treatment?
>
> The pharmaceutical industries often accuse activists of ignoring other
> barriers to treatment. There are many, including poverty, lack of
> government will -- throughout the third-world, with a few notable
> exceptions -- to tackle the epidemic, lack of government finance
> throughout the third-world, poor health-care infrastructure in many parts
> of South Africa and throughout Africa, social stigma and ignorance
> associated with the disease, poor adherence by patients to drug regimens
> (throughout the world, in rich countries as well as poor) and lack of
> skilled medical personnel. However, the central barrier is affordability
> of medicines and testing procedures. TAC and its allies have been and
> remain firmly committed to combating all of these problems.
>
> 18 The drug companies argue that strong intellectual property incentives
> are needed to maintain investment in new research. What is TAC's response
> to this?
>
> It is true that the cost of researching and developing new drugs is very
> high. However, the following points should be considered:
>
> * Most research into new essential medicines, particularly
> anti-retrovirals, occurs in the public sector. Pharmaceutical companies
> usually invest money in the final stages of research and development
> (R&D), when a new drug looks promising. Often they simply buy patents from
> public institutions or other companies (e.g. d4T and fluconazole, but also
> many others).
>
> * Africa accounts for approximately 1.3% of global pharmaceutical sales.
> Issuing compulsory licenses will not significantly affect brand-name
> pharmaceutical company profits.
>
> * When compulsory licenses are issued, they are supposed to be accompanied
> with compensation for the patent-holder, usually a royalty payment on the
> sales of the generic product.
>
> * The industry is not as risky as the pharmaceutical companies pretend it
> is. The pharmaceutical industry is one of the most profitable industries
> in the world by almost any measure. According to a recent study by Oxfam,
> pharmaceutical company profit to capital ratios average 15%, while the
> average in industry as a whole is less than 8%.
>
> * Brand-name pharmaceutical companies spend more money on marketing than
> on research and development.
>
> * There is very little pharmaceutical industry R&D into essential
> medicines that predominantly affect the third-world.
>
> * Patent protection throughout the world has become stronger in recent
> years. For example, South Africa has increased the length of the patent
> term from 16 to 20 years in order to be TRIPS compliant. Brazil did not
> patent pharmaceutical products until recently. India will introduce
> patents on pharmaceuticals products into law before 2005. The
> pharmaceutical companies have never had it so good.
>
> Generic production of essential HIV/AIDS medicines is the only way to
> ensure a sustainable supply of affordable medicines in South Africa and
> many other developing countries. TAC will campaign for a research and
> development tax of 1% on all generics sold in South Africa.
>
> 19 What can people do to help?
>
> You can ask the company or institution you work for to issue a statement
> of support for the Medicines Act. Join an organisation campaigning for
> affordable access to health-care in your area. Join TAC and make
> donations to our organisation.
>
> ###
>
> Letter to the South African President, Minister of Health and all
> Members of Parliament, concerning the development of a treatment plan and
> the declaration of a health emergency
>
> President Thabo Mbeki
> Minister Manto Tshabalala-Msimang
> Members of Parliament
> 14th March 2001
>
> Dear President Mbeki
>
> DRAFT A TREATMENT PLAN AND PREPARE TO DECLARE HIV/AIDS A PUBLIC HEALTH
> EMERGENCY! APPLY FOR VOLUNTARY LICENCES FOR HIV/AIDS DRUGS!
>
> The Treatment Action Campaign (TAC) believes that the current debate and
> discussion on whether to declare an emergency in relation to HIV/AIDS is
> important for all people in South Africa. For us the HIV/AIDS epidemic has
> always been a matter of great urgency. TAC supports COSATU's view that
> HIV/AIDS presents a serious threat to the future of South Africa and that
> it requires urgent, emergency measures. However, the government needs to
> complete a few steps before declaring a public health emergency.
>
> EMERGENCY AND TREATMENT -- WHAT IS THE LINK?
>
> Cosatu states correctly that the unnecessary loss of lives due to
> profiteering has reached crisis proportions in our country. This is an
> emergency. In addition, says Cosatu, there is no sign that the
> government's ABC message is working. TAC agrees. Treatment of people
> living with HIV/AIDS is the critical element that has been left out of the
> equation. Prevention and treatment are inextricably bound together. Most
> people will come forward to be tested only if there is a benefit to it,
> that benefit is treatment. Such an approach will encourage openness and
> allow social mobilisation. It also dispels the myth that HIV/AIDS is a
> "death sentence". Access to medicines, especially anti-retrovirals, remain
> beyond the reach of the majority of people and the government because of
> high prices and patent abuse. This is an issue of great urgency to all of
> us.
>
> There are different ways of addressing the critical obstacle of patent
> abuse by drug companies - declaring a public health emergency is one of
> them. TRIPS, the World Trade Organisation's agreement on intellectual
> property rights allows exceptions in cases of "national emergency" or in
> "circumstances of extreme urgency". There are other routes such as
> applying for voluntary and compulsory licences in terms of the Patents Act
> as well. However, government should have a clear treatment plan before
> declaring a public health emergency.
>
> DEVELOP A TREATMENT PLAN NOW!
>
> The drug companies are on the defensive and they are lowering their
> prices. World opinion supports action by the government but undue haste
> will not automatically lead to solutions. TAC urges the government to
> immediately develop a treatment plan that includes a list of all the
> medicines needed to treat HIV/AIDS. This includes drugs for opportunistic
> infections and the prohibitively priced anti-retroviral medicines. A clear
> plan on training all health workers and a public campaign on voluntary
> counselling and testing is essential. Additional investment in clinics,
> laboratory facilities, hospitals and staff are essential components of a
> treatment plan. Sources of funding must be identified to ensure that a
> treatment plan is sustainable.
>
> A public health emergency will suspend the property rights of drug
> companies on all essential HIV/AIDS medicines including anti-retrovirals.
> Government's first step to ascertain whether a public health emergency
> will be necessary will be to request, in writing from every drug company
> voluntary licences for opportunistic infection and anti-retroviral
> medicines. Such licences will allow local generic manufacture and
> competition on patented medicines. If they agree to voluntary licences
> such an emergency may not be necessary. But, government must ask them for
> licences now.
>
> Another alternative is to use the Patents Act and to apply for compulsory
> licences through the Courts. Such a procedure might be more onerous
> because the drug companies will drag matters on forever in a Court of Law.
> Therefore, TAC calls on government to draft a Treatment Plan by 16th June
> 2001 and to make it an Act of Parliament. TAC also asks government to
> report to Parliament on drug company responses to requests for voluntary
> licences before 27th April 2001.
>
> For people with HIV/AIDS, faced with imminent death and little prospect of
> treatment the matter is of great urgency as reflected in the Cosatu
> statement. TAC appeals to all politicians to practice restraint and to
> place the lives of people before petty politicking. The Democratic
> Alliance opposes the Medicines Act. Yet, the Medicines Act will prevent a
> situation that allows drug company profiteering at the expense of life.
> This is necessary for all medicines not only drugs needed for the
> treatment of HIV/AIDS. TAC asks all parties to initiate and support a
> motion in Parliament asking all drug companies to drop the court action
> against the government.
>
> TAC once again draws your attention to the Memorandum delivered to
> Parliament on 12th February 2001 and urges government to respond to that
> Memorandum.
>
> Yours faithfully
> Zackie Achmat
> (TAC Chairperson)
>
>
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