Summary. Introduction page 2. And Public Health page 3. Stake For The Pharmaceutical Laboratories (Companies) page 9. Environment and Politics page 9.
The Ethical Dilemma page 10. Is There A Solution page 13. Source, References and Interesting Related Readings page 14 Introduction The problem regarding the sales of essentials drugs in developing countries is a very vast and a very complex issue, interacting with human rights and intellectual property, localization differences, for instance over the different issue, the north of Africa is treated differently than the south, some developed countries support some developing countries and not others, … I did not know anything about that topic before that, so first part of my work here has been to found out, collect, read, analyze, all the information I have mostly found on the internet to explore this issue. I will focus on giving an overall overview of that tremendous issue and the ethical dilemma generated thru these different commercial agreement and intellectual property rights.
A lot of African medical web site are dealing this tremendous problem in these countries. After having explained in short the recent agreement conclude with the WTO last August 30 th, 2003, I’ll focus on the different Intellectual Property And Public Health The intellectual property is the key issue in that problem. Once a laboratory discover a molecule potentially efficient, it patent it. From the date of the patent, the company (laboratory) has 20 years to exploit, produce and market its drug, before the patent is getting public and thus give the possibility for different laboratories the rights to copy, produce and sale it as a generic drug. The average price of a generic drug is about 30% less than the original (up to 50% in some cases).
The main organization regulating these different agreement, are the world trade Organization (WTO) and in some case the world health organization is involved (WHO). The Overview In April 2001, 39 pharmaceutical companies gave up the legal proceedings which they had brought against the South-African government in order to prevent it from giving access to the population drugs at low prices. By withdrawing their complaint, the companies gave up disputing the right of the governments to profit from the protection clauses from the agreement from the World Trade Organization (WTO) on the rights of intellectual property. The African governments asked the Council of the TRIPS (trade-related aspects of intellectual property rights) of WTO, which is in charged to take care of the implementation of the agreement, to examine their claims. They estimate indeed that the intellectual rights and the patents prevent the poor countries from obtaining the drugs which they need to fight against the diseases which devastate their continent (especially contagious disease). What Is The TRIPS And Its Obligations (trade-related aspects of intellectual property rights) The agreement on the TRIPS obliges the 140 governments members of WTO to ensure during a 20 years protection by copyright and patent of new products.
During this period, nobody can use, manufacture or sell a product without the authorization of his inventor (laboratories). After the expiry of the patent, other companies then have the right to sell “generic” versions of the product. The TRIPS also protect the trade marks and the trade secret. The industrialized countries were to adopt national laws in conformity with the TRIPS before January 1996. The majority of the developing countries and the countries of the old Soviet block were to be put in conformity before 2000, while the least advanced countries (LAC) have until January 2006 to conform to it. These poorest countries have however the possibility of requiring an extension to WTO.
The countries which do not have a national legislation in conformity with the TRIPS expose to penalties, and in particular to commercial sanctions. The TRIPS define minimal standards making it possible to protect the holders of patents, but these rights do not have anything absolute. Dr. Gro Harlem Brundtland, general Direct rice of the WHO pointed out the following: “The current system of international trade agreements aims at reconciling the rights of the holders of patents and the patient’s rights and the agreement on the TRIPS comprises significant protection clauses of the public health.” These protection clauses allow the countries which wish it to be exempted obligations of the TRIPS by granting obligatory licences, while proceeding to parallel imports and by calling upon the provisions known as “Bolar.” Public Interest Against Private Sector India and Thailand belong to the countries that have authorized companies to produce generic “versions” of drugs having been patented in industrialized countries, using methods of production different from those developed at the point by the manufacturers from original one.
The drugs are then sold also at very low price to other developing countries. Seven years after the first marketing of the ciprofloxacin (which is used to prevent the intestinal infections of HIV-positive person person) 48 laboratories produce in India a generic versions of this drug, which is patented in Europe and in the United States. The Indian company Cipla recently spoke about proposing some “triple cocktail” of anti-retrovirus drugs at the price of 600 dollars (cost by year / person ) for the African governments and of 350 dollars for a nongovernmental organization present in Africa. The cocktail of these three anti-retrovirus drugs is now usually used in the fight against the AIDS virus.
Thanks to these drugs, a HIV-positive person is not condemned any more to died but can on the contrary live a longer time. In United States, these drugs cost of 10 000 to 15 000 dollars year per person. In fact, the pharmaceutical groups make pressure, in particular to the governments, so that the latter are not supplied by the generic manufacturers of drugs. These manufacturers copy existing pharmaceutical products without seeking to develop new drugs. But, the poorest countries and in particular in sub-Saharan Africa, cannot buy at high price the drugs which make it possible to fight against fatal diseases like tuberculosis, malaria and AIDS/HIV. However the situation is far from being clear, because Brazil and South Africa, two developing countries which dared to interpret the substantive patent law in the interest of their population, are the subject of international legal proceedings.
Brazil was shown by the United States to contravene the provisions of the TRIPS, the disputes has been settled by the WTO. In 1996, Brazil adopted a law authorizing the local production of five anti-retrovirus drugs essential used in the United States. Some of these drugs, such as for example the TEA, which prevents the transmission of the HIV of the mother to the child, had been patented before 1995, i. e. before the entry into force of the provisions of WTO. The TRIPS thus do not apply to the case of these drugs.
In accordance with its substantive patent law, Brazil authorizes the production of these drugs, without any royalties being versed to the laboratories. They were able then to manage to provide free drugs to the people infected by the HIV/AIDS. Recently, Brazil succeeded in persuading the American company Merck to reduce the prices of two of its drugs against the AIDS, Crixivan and Stoc rin, while threatening to grant obligatory licences if Merck did not reduce its prices by 50 %. From the American government, the Brazilian laws involve a discrimination against the foreign holders of patents.
In accordance with one of its law aiming reinforcing national pharmaceutical industry and at reducing the price of the drugs, Brazil respects a patent only if the drug in question is produced locally. The alien companies must thus be established in Brazil to profit from this protection. According to the United States, this obligation is against the agreement on the TRIPS. The American government thus tried to lead Brazil to modify its substantive patent law and its policies as regards of drugs, by exerting significant diplomatic pressures, relayed by threats of unilateral commercial sanctions.
Last year, Ghana tried to buy at low prices generic drugs to fight AIDS virus from the manufactured Cipla. The holder of the patent, GlaxoSmithKline, indicated that a patent had been deposited for this drug in Ghana and, in spite of the opposition of the authorities, no contract was concluded. GlaxoSmithKline admitted having made an error thereafter. In the Nineties, the United States persuaded a certain number of countries to reinforce their right of the intellectual property well before the cut off dates fixed by WTO, by holding up the spectrum of possible commercial sanctions.
One of the provisions of the American commercial legislation authorizes Washington unilaterally to impose sanctions against exports of a country which does not satisfy certain conditions. After having threaten to take sanctions against South Africa, president Bill Clinton signed an executive decree aiming at softening the American right of the intellectual property applying to the distribution in sub-Saharan Africa of drugs against the HIV. Under the terms of this decree, no American organization can threaten to carry felt sorry for at WTO or to call upon an unspecified violation of the American right of the patents in order to dissuade the countries from sub-Saharan Africa to produce or obtain drugs against the AIDS. Brazil is often quoted as an example that the African countries could follow. The three main clauses of the TRIPS: Compulsory licenses.
The expression used on the agreement is in fact the following: ” Other uses without license of the holder of the right .” The governments have the possibility of authorizing a third party to make a product without the license of the holder of the patent. Before seeing granting the license, the applicant has to try to obtain the permission of the holder of the patent according to reasonable commercial conditions. In the case of the granting of a compulsory license, a payment corresponding to the current prices, must be paid to the holder of the patent, the license is then valid only on the inner market and will be cancelled as soon as circumstances will evolve. it is possible to grant a compulsory license without trying beforehand to obtain the permission of the holder of the patent. Parallel imports. The governments can authorize the parallel imports of drugs: a product patented in a country and sold at a lower price in another country can be imported from this second country without the permission of the holder of the patent Capacities ” Bolar .” These capacities allow the manufacturers of generic products to begin the production and the statutory procedures before the expiration of patents, so that products are ready to be marketed as soon as the patent expires, instead of having to wait for the end of the patent to start the long preparatory phase.
All of that shows that the situation is very complex and that there is no reel solution since the economical strakes for the pharmaceutical laboratories are huge. All that rules and laws were resulting from the TRIPS agreement signed in Doha with the WTO in 1994. Since that date, several declarations and capacities have been defined and recently, on august 30 th, 2003, WTO member governments broke their deadlock over intellectual property protection and public health today. They agreed on legal changes that will make it easier for poorer countries to import cheaper generics made under compulsory licensing if they are unable to manufacture the medicines themselves.
Stake For The Pharmaceutical Laboratories (Companies) The issue regarding the stakes for the pharmaceutical laboratories is purely economical. The average time to develop a new molecule is about 15 years and the cost is about 250 million dollars for instance for a drug against the HIV. Thus, the pay back of these years of research and development is key for the pharmaceutical laboratories. On one hand, most of these companies arguing that, having one world wide pricing policy (usually high) is the best way to maintain and keep financing the research and development. It has to be mentioned that, beside this official speech, some laboratories have already signed up special agreements (right to copy and produce some drugs) with some African countries, but that is exceptional. On the other hand, the research budget for the 3 most mortal infectious diseases (tuberculosis, malaria and the HIV) is lower than 5% of their total research budget.
It is lower than 1% at Pfizer and Glaxo-Smith klein-Beecham. Environment And Politics Over the legal environment of the issue that has some huge consequence on the developing countries populations, few words have to be mentioned about the strong effect of the unstable political situation of most of these countries. For instance, over the 50 states composing the Africa, only few have a stable political government. We can not count the number of putsch, some not bloody but some are, like in Biafra, Rwanda, at Kinshasa, in Liberia or more recently in Ivory Coast.
This political fragility and instability in addition to the “bad” management of the government, have multiple effect on the health of the populations. This makes the humanitarian aid associations the daily answer to support the populations and deprive the health structure of their budget and means of operation. The Ethical Dilemma “Should we let people dying to make more money? ” Human Rights The ethical dilemma is first based on the definition and the respect of the fundamental basics of the human rights. “The right to health is part of the humans rights.” In eighties only, the international community has questioned the health issues as the birthrate of the HIV/AIDS with the human rights. Thus, few human rights in dissociable from the health appear to be fundamental. The right to the non discrimination: it is a key principle for the human right practises in general and for health in particular.
The right to profit from scientist innovations and its applications: it is today, a key stake for international health since there are huge discrepancies between the north and the south in that respect. The right to health: which means the rights to an individual, to his autonomy, his information, his education and his participation the social life. Today, the obstacles to cross to apply these rights to health are: . Reduce the infant mortality and promote the “clean” development of children… Improve the environmental sanitary aspect… Prevent, treat and control the infectious diseases…
Create all necessary conditions to an everyone access to health. Consequences, Here Is The Dilemma In all health issues happening in developing countries, some are directly linked to the access of drug, some not. I will below try to list the one mostly linked to that access to health and drugs. In Africa for instance, the AIDS is the first mortality cause, before the malaria, tuberculosis and wars (28. 1 million people HIV contaminated in sub-Saharian Africa over 40 million world wide). The non access to new drugs to limit the effects of the HIV and to allow peoples to get older is the tremendous issue and ethical issue that the pharmaceutical laboratories have to face up to.
Indeed, this high mortality rate is for the development of these countries translated into a lake of manpower and a weak manpower, increasing the difficulties for those countries to develop themselves and increase the standard of living (if standard of living is the appropriate term in that respect! ) In such a condition it is useless to talk about economical environment as a development axis for these countries. Few numbers: the mortality rate including the mortality due to the AIDS, are 50 to 500% higher in East Africa as what they should have been without AIDS. AIDS will cost about 17 years of expectation of life to the 9 countries where the HIV is touching more than 10% of the adult population (South Africa, Botswana, Kenya, Malawi, Mozambic, Namibia, Rwanda, Zambia and Zimbabwe). This expectation of life decrease is both due to the direct death of adult and children. In case of the adult death, children are getting orphan reducing again their chance to get access to health. Since the adult mortality rate will increase, the orphan rate will increase as well.
Furthermore, the non access of the poorest population to new drugs to fight the HIV has completely annihilate the 40 past years of vaccination against malaria and tuberculosis and that is the issue too. AIDS reveal the ethical issue behind the access to the drugs since all the new different treatment are not accessible by 90% of sick person in the world. Indirect consequence to the people infected by the HIV (direct consequence of the non access to the drugs), is the access to a job, which is another ethical issue in regards of the human rights. In south Africa for instance, a law has been voted to prohibit the HIV test when recruiting people. Is There A Solutions? Over the all different sources I used to pictured a part of this wide and very complex issue, different proposal are made by the main actors of the world, the WTO, the WHO, the humanitarian aids, the USA, the EU and the pharmaceutical laboratories themselves but most of them seems to be to far from the reality according to the concerned people. US pharmaceutical firms and US government as well were criticized regarding their politic in that respect, but for instance, thru the infringement accepted by them for some drugs to be copy, produce and sold (in the same country) by developing countries, only Brazil took the opportunity to evolve and improve is access to the drug.
None of the African countries did so, most of the African government do not work to really solve this issue. On the other hand, we can read that US government, the EU and pharmaceutical firms are putting a strong pressure over these African countries not to do so. The different agreement signed up and especially the one in Doha in 2002, planned to declare the superiority of the right to health over the right to the patents. Thus, poorest countries got the rights to import drugs at low cost, the generics, to save millions of life. Developing countries, non producers of drugs, supported by the non governmental organizations wanted to define themselves which disease was a public health issue in their countries.
But, the US, worried to preserve his pharmaceutical industry from the competition of the generics, mentioned that the way in which the text was written, presented some risks of extension of the agreement to non contagious diseases like asthma, diabetes. This would fragilized the protection of the patents then would weaken the research and the development of new drugs by the pharmaceutical firms. This potential risk have been evaluated to be about 50 billion dollars of loss of sales if generic drugs for non contagious diseases would compete. EU, is not “cleaner” in that respect, also trying to preserve his pharmaceutical firms for an uncontrolled competition. Over the pure economical aspect of the patent rights agreement, non governmental organization have proposed to redefine and restructure the humanitarian aid roles, develop more partnership with the poorest countries, … As I said, this issue is very complex and nobody can pretend to have the right solution, if a short term and a long term really exist.
As a manager, it is very important to be aware of such a kind issue, trying to be objective in regards of all the actors and issues interacting all together. Sources, References and Interesting Related Readings Books: Alternatives Internationales Juillet-Aout Internet Web Site: web > web > web > http: //216. 239. 37. 104/translate? hl = en&u = web > web > Reports: La Coop ” eration Dans Le Secteur De La Sant’e Avec Les Pays En D’eveloppement Rapport du Haut Conseil de la Coop ” eration Internationale – R’epublique Francaise -June 25 th, 2003 Rapport sur le d’eveloppement humain 2000 PNU D Impact D’emographique Du HIV/AIDS Ben^it Ferry, january 2002 Comment Developer La Production Locale Des Medicament’s Tradition nels? Mardi 12 novembre 2002 Faculty de pharmacie, paris v web.