Medicines fight pathogens, prolong life, help with chronic diseases, relieve pain, relieve anxiety, some make you euphoric, others let hair grow back or help you lose weight. In the past, there was a medical plant for every illness. Today there is a pill for every problem. But there is also another side to the pharmacological wonder world: massive advertising activities to increase sales of problematic combination preparations, questionable expansion of indications of useful medicines, innovations with only minimal additional benefit, research orientation on lucrative markets instead of urgent health problems for people without purchasing power and diseases of poverty. What is needed here is an authority like the World Health Organisation (WHO), which should have the health needs of all people in mind.
Indeed, disputes between the WHO and the commercial pharmaceutical industry have been an important part of its work since the 1970s at the latest. From the very beginning, the major corporations fought against the development of the WHO concept of Essential Medicines[1], which first highlighted the jungle of wildly proliferating combination preparations and unproved substances in 1977. The idea that a limited and manageable list of a few hundred substances should be sufficient for the most important human diseases drove the corporations onto the barricades. Despite all the scientific expertise that the WHO offered in its bi-annual commissions for the regular further development of the Model List of Essential Medicines, they denounced the concept as "minimal medicine for poor people in poor countries".
Mistrust of generics
Even though 140 countries have now created their own national "essential medicines lists" for their public health services on the basis of this model, the pharmaceutical industry has often succeeded in preventing them from being used, especially in the high-priced markets of the industrialised countries. Even the well known conservative Bavarian Politician Horst Seehofer failed in the 1990s as German Minister of Health with such a plan in the Bundesrat, the second chamber of German Parliament, when the pharmaceutical lobby threatened the majority of then social democratic provincial prime ministers with job cuts. Even a new attempt in 2003 with politically reversed signs did not bring success.
A second line of defence of the pharmaceutical lobbyists was the deliberately sown mistrust against the generic drug manufacturers, who reproduce successful drugs at low prices. The German company Ratiopharm (now part of Teva Pharmaceuticals) also had to fight against these prejudices in Germany. The international manufacturers, especially those from India, were hit harder. Not only is the quality of their products constantly being questioned. They are also systematically brought into close proximity with "brand piracy" and counterfeit medicines. This strategy intends to halt the erosion of pharmaceutical markets for the originator companies, especially in emerging markets.
In addition, the transnational pharmaceutical companies are all too willing to use drug donations to keep unwelcome generics and thus competition at bay, both in the WHO and in large countries.
A classic example is the Novartis donation program for its innovative leukemia medicine Imatinib (Gleevec® ) in the early 2000s. At an annual cost of USD 150,000, it was unaffordable not only for patients in the poorest countries, but also in the emerging middle-income countries. While Novartis, despite strong international criticism, tried to obtain patent protection for its drug in India to prevent generic production by the local pharmaceutical companies, it set up a charitable foundation. This foundation made the medicine available to poor patients* in 80 countries. At the same time, the companies tried a similar strategy with the "Global Fund to Fight Aids, TB and Malaria", to which they offered extensive medicines donations in order to keep the successfully developed competing products of Indian companies from being financed by the Global Fund. Once again, quality arguments were used. In order to invalidate these, the WHO began its own prequalification programme[2], which has since been used to subject the producers of generic medicines who supply their goods to treatment programmes financed by the Fund to extensive quality checks.
Do-or-Die for patents
However, the pharmaceutical industry is fighting the most persistent battle over its "innovation model" of intellectual property rights. Only through these rights, which are protected by the patent system, the high monopoly prices can be achieved that make the "blockbuster" model of current pharmaceutical research and production possible. Few successful products are massively advertised and quickly pushed into the market in order to achieve maximum profit in a short time. Stock market quotations and dividends depend on this. Although the high research costs and numerous failures up to the new "blockbuster" drug are cited as justification for this model, the large corporations no longer always conduct their own research. Instead, they use the enormous profits for shopping trips and mergers: Small biotechnology companies that have largely taken the development risk away from the "big" companies are swallowed up as soon as they can demonstrate promising research results.
The hepatitis C medicine Sofosbuvir (Sovaldi®) from pharmaceutical giant Gilead was such a relevant breakthrough. In Europe, the treatment still costs more than 43,000 €, while international generic competition has pushed the price of Sofosbuvir down to less than 100 €. It was developed by a small British start-up Pharmasset, estimated development costs at the time of the takeover between 43 million USD (for Sofosbuvir alone) and 271 million USD (including failed candidates). In the takeover battle in 2013 between the giants, the US company Gilead was finally successful with 11 bn USD. It should be worth it. After only two years, the drug had already generated 35 bn USD[3].
Another dramatic consequence of this market structure is the systematic distortion of research and development priorities. Large companies primarily do research efforts where the desired sales can be realized. The focus is on new medicines for the treatment of cancer, mental illness, diabetes and other chronic diseases of people whose social, insurance and health care systems bear the enormous costs. In contrast, antibiotics research has largely been discontinued because the short-term treatment cycles and the status of reserve treatment of every new class of antibiotics promise much lower profits.
Minor corrections to the system, such as the hopes for innovation for rare diseases through an extension of market exclusivity for such "orphan medicines" by the US or European Medicines Agency[4], will not change this imbalance. What is needed is a consistent separation of research and development costs from prices. Only in this way can innovations be made available to all people quickly and as cheaply as possible. The WHO is also the right platform for this debate. Here it could prove its unique function as the multilateral player in global health policy with a mandate to negotiate binding agreements under international law.
However, this happens all too rarely. Current exceptions are the treaties of the Tobacco Control Convention and the International Health Regulations, which regulate the cooperation of member states in the event of global health emergencies.
It was in 2012 when, after a decade of analysis and negotiations in the WHO Commission on Intellectual Property Rights, Innovation and Public Health, the Consultative Expert Working Group on Research and Development put a proposal on the table. It provided for a binding framework agreement on "Open Knowledge Innovation", with which joint public funding of research by the WHO member states should be agreed according to their economic performance[5]. This would put the knowledge generated, the products and even licenses under public control. In this way, drugs could be reproduced cost-effectively by all. That same year, this proposal failed in the World Health Assembly, not even the then Director-General Margaret Chan had backed it.
Patentpools could help
The coronavirus pandemic could, with an optimistic twist, be the right opportunity to make a fresh start. With the new Covid-19 Technology Access Patent Pool[6], which was presented by Costa Rica and the WHO at the End of May, a model is now available in which knowledge about the virus and the instruments for combating it would be bundled and made available to all in a free licensing procedure. This would make it possible to overcome the blockade that has existed for decades, at least for the current crisis. However, among the 36 governments that support the pool, only five from smaller European countries (Luxembourg, Portugal, Belgium, the Netherlands, Norway) have so far joined. The German Chancellor may now like to talk about "global public goods": The German government, like the heavyweights Great Britain, Russia, China and of course the USA, is resolutely reluctant to make the move that would guarantee just that.
In the "Coronavirus Global Response"[7] fundraising campaign launched by the EU at the beginning of May, Germany pledged 525 million euros, which are to be channelled into various initiatives for diagnostics, vaccine and drug research and the production and distribution of the products (eg the Coalition for Epidemic Preparedness Innovations[8]) - a substantial financial contribution. But politics is not made alone with a cheque book. The structural conditions are essential. The Covid19 pool would be the appropriate approach to enable the concrete implementation and accessibility of such innovations. It would prevent the big private players from once again setting prices for their patented products and public investment from immediately turning into private profits. This is an area where we need to continue to argue in the coming period.
[1]https://www.who.int/topics/essential_medicines/en/
[2]https://www.who.int/medicines/regulation/prequalification/en/
[3]https://aihta.at/page/finanzielle-spekulationen-behindern-versorgung-mit-arzneimitteln/de
[4]https://www.ema.europa.eu/en/human-regulatory/post-authorisation/orphan-medicines/market-exclusivity-orphan-medicines
[5]https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001219
[6]https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-technology-access-pool
