Patent thwarted

Drug research suffers from global patent protection

For more than 25 years, the World Health Organization (WHO) and numerous nongovernmental organizations (NGOs) have been working to give Third World countries access to cheap medicines. The AIDS epidemic has given an unexpected boost to these efforts: for the first time, there are millions of patients who can only be treated with expensive patented drugs. But price cuts alone will not help where patent rights impede the supply of medicines.

"No medicines for the poor?" asks development sociologist and health scientist Jorg Schaaber in his book of the same name. He shows why vital medicines are not accessible everywhere and what role the international pharmaceutical multinationals play in this.

The TRIPS Agreement

Two thirds of all people with HIV. Only 12 percent of them have access to AIDS triple therapy, which is considered the standard of care in industrialized countries (3 by 5. Progress Report December 2004). Aids has reduced life expectancy in this region to 47 years. According to treasures of the WHO in the World Health Report 2002 it was 62 years without Aids.

These numbers are horrible enough. Nevertheless, the spread of immunodeficiency has become more explosive mainly because it coincides with another development: the globalization of patent rights (pills and patents) on medicines under the TRIPS agreement, to which all members of the World Trade Organization (WTO) must commit themselves.

The Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement sets high standards of intellectual property protection and provides detailed procedural guidelines for the enforcement of these rights. It aims to harmonize intellectual property laws, which requires developing countries in particular to significantly tighten their legislation: Since the beginning of the year, all member states have had to accept 20-year patent rights for pharmaceuticals, and many of them have already introduced patent protection for medicines. For the poorest countries there is still a last delay until 2016.

No price discussion

In the 1980s, high prices were still seen as the main obstacle to the supply of medicines to developing countries, and the focus was on a targeted selection of medicines (since 1977, there has been the WHO list of essential medicines, which since 2002 also includes patented medicines). The high costs were criticized for the first time because of AIDS; prices began to move and in some cases dropped enormously. But it also became clear that drug donations and price reductions alone do not help, and that the reasons for the drug shortage go far beyond a lack of money.

Seit 2005 mussen alle WTO-Mitglieder Patente anerkennen. Thus, countries without their own drug production have had to rely on circumstantial procedures to import generic drugs (imitations of patented drugs) or make use of compulsory licensing, a tricky instrument that comes with many restrictions and bureaucratic obstacles.

India passed a patent law this year. After protests, it did not turn out to be quite as heavy-handed as planned. All new drugs now fall under patent protection. A compulsory license had to be granted in order to be able to reproduce cheaply in individual cases. This is a possibility created by the WTO to ensure the supply of medicines in emergencies. However, no country has really made use of it so far, because it is openly opposed – with a powerful industry and powerful governments.

Jorg Schaaber, book author and contributor to the BUKO Pharma campaign to Telepolis

And he predicts that "production in countries that have a significant pharmaceutical production – such as the. B. India, a major supplier of low-cost (AIDS) drugs – will eventually dry up if nothing decisive is done about it."

When Sud Africa sought to enshrine the right to grant compulsory licenses in its legislation in 1997, the pharmaceutical industry filed a lawsuit in the country’s Supreme Court, the Clinton administration at the time imposed trade sanctions, and the EU exerted diplomatic prere. The international corporations have thus made it unmistakably clear that they do not want to give up their rights and have no interest in making medicines cheaper.

Cheaper prices could create covetousness in the industrialized nations and a price discussion is not wanted. Because the pricing of medicines is about as light and clear as a foggy November morning. In his book, Schaaber points out that it is precisely this lack of transparency that is the basis for "expensive products achieving a high market share without any connection to their actual benefits being apparent".

With the global enforcement of patent rights, pharmaceutical companies have been able to consolidate their monopolies, which, according to Schaaber, can only be broken by global competition. "To ensure low prices in the long term, regionalized production of medicines is necessary. However, the WTO does not provide a basis for demanding the necessary economic development. The technology transfer predicted by the industry through the TRIPS Agreement to the 3. World did not come to pass. The poor countries had to exclude certain areas from patentability altogether in order to safeguard their basic needs."

Research for 10 percent of the population

Companies base their research primarily on marketing opportunities rather than medical need. According to the WHO, 90 percent of research expenditures are spent on 10 percent of the world’s disease burden.). For most diseases, therefore, nothing takes place, and this is due to the structure of research, which is dominated by the patent system: because patented drugs only guarantee high revenues if the markets have a high purchasing power, research is only done for the wealthy.

"Current private-sector drug research is cumbersome, expensive and inefficient," criticizes Schaaber. "Advances are the exception, patent law sets wrong incentives. Research focused on lucrative outlets with large numbers of patients, preferably chronically ill, who have the ability to pay, or lifestyle drugs. In fact, the health problems of poor countries account for 90 percent of the global burden of disease."

Investigations by the Food and Drug Administration (FDA) show how counterproductive the system is. It regularly evaluates new drugs to see if they bring a "significant improvement in the treatment, diagnosis or prevention of a disease". However, this was true of only 23 percent of newcomers in the period from 1990 to 2002. The rest is, to put it bluntly, the same in Grun. This is how research funds are wasted – but this is exactly what is rewarded: Because the "new" drug is launched on the market with a new patent and ensures high profits.

A highly subsidized system

The OECD study Health at a Glance on health in OECD countries has just shown that an excellent supply of medicines, calculated on the basis of sales figures, does not necessarily lead to a longer life expectancy. In a comparison of life expectancy and expenditure on medicines, one country stands in a very isolated position: the USA, the country with the highest expenditure on health worldwide and a comparatively miserable life expectancy: 5635 US dollars (per capita, adjusted for purchasing power, 2003) with a life expectancy of 77.2 years. Japan, on the other hand, reaches 81.8 years with less than half of the health expenditure (2139 US dollars). Germany also performs significantly better than the U.S. with 78.4 years and 2996 U.S. dollars).

"The whole research system is sick in itself," says Schaaber. "We urgently need a discussion on better models of research demand. And there is a need to rethink who really owns intellectual property. Let’s take the USA: There, a lot of basic research is funded by the state. New active ingredients are developed at universities, and it is not until the clinical trials that industry finally gets involved and secures the patent rights and thus the big bucks. The drug supply is basically a highly subsidized system, it’s funded by taxes and by the health care systems, and ultimately it’s all paid for by the burghers. People tend to forget that. There is hardly any other industry in the world that has such a secure market as the pharmaceutical industry."

What else did Trips bring?

But the struggle to provide Third World countries with better access to medicines has also ushered in a positive development: Third World countries became increasingly active in the WHO and they successfully developed common positions. Thus, for the first time, the group of African countries introduced its own draft resolution at the WTO Ministerial Conference in Doha in 2001, which it was able to push through almost word for word. In CancĂșn in 2003, the Third World also showed itself to be a powerful coalition: The WTO conference failed because the industrialized nations did not want to give in on agricultural ies, but neither did the poor countries.

In this process, NGOs played an important role as informers and catalysts. They were able to draw on many years of cooperation and expertise, and succeeded in involving new partners. And it has been shown that NGOs can generate enormous public prere, which does not fail to have an effect. The best example is again Sud Africa, where the wave of international protests forced the pharmaceutical industry to withdraw its lawsuit against Sud Africa. The example of Sud Africa was an "aha" moment for many people. It surprised everyone how rough the effect of public protests is," Schaaber explains. "And I think this success also had a lot to do with the Internet. In the past, communication to the Third World was done by letter, because there were few fax machines. The Internet has speeded up communication considerably. When the discussion about AIDS arose, there were already networks, lateral entrants were able to join in quickly and strategies for action developed and spread quickly."

Public-private partnerships: turning the buck into a gartner

The public has become more sensitive, but the pharmaceutical industry has developed strategies against criticism, including the so-called "public private partnerships". These involve private companies as stakeholders in government activities by helping to shape programs and structures. Schaaber considers this a "fatal and very undemocratic development that should be critically monitored".

Patent thwarted

The supply of essential medicines is a basic human right. Schaaber sees signs that change is beginning to happen here:

Even the World Bank has recognized that securing basic needs is central to the well-being of entire economies. WHO, UNICEF and UNAIDS are increasingly aggressive in advocating the right to access to medicines. The Club of Rome has just published a rough study on privatization (Ernst Ulrich von Weizsacker (Editor) et al.Limits to Privatisation – How to Avoid Too Much of a Good Thing), which also deals with the following ies. a. about drug research. It is presented as an example of unsuccessful privatization of a public task. It is encouraging that scientists there are also arguing for a turnaround. On the other hand, it is clear that the opposing forces are very strong and their influence is enormous.

Jorg Schaaber: No drugs for the poor? Obstacles on the way to a fair drug supply using the example of AIDS. Mabuse Publishing House, Frankfurt

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