lördag 7 januari 2012

Piracy and the changed nature of medical research

Medical research has never been so successful. Despite this, many doubt if the findings will translate into new drugs and treatments. The present patent system and business models of the pharmaceutical industry are being scrutinized with the light of the impending patent cliff. Pharmaceutical research is a commitment of long duration, while investors demand ever more rapid return on investments.

The Swedish Pirate Party strives to reform laws regarding copyright and patents, strengthening the right to internet access and daily privacy and increase the transparency of government administration. The Pirate Party gained one seat in the European Parliament after winning 7.1 per cent of the votes in June 2009, joining the Greens-EFA group. In September this year its German sister party gained seats in Berlin's state parliament. There are registered Pirate Parties in several European countries, including the UK.

Gradually expanding their focus from the issue of file sharing, pharmaceutical patents entered pirate policy. The programmes of the Swedish and German parties are deeply critical to pharmaceutical patents calling for their abolishment.

Thanks to universal health insurance, government subsidies account for the majority of the pharmaceutical companies' revenues in Europe. Only 15 per cent of the revenues of the companies actually go to research, the remaining mainly goes into marketing. Instead, governments should allocate 20 per cent of today's drugs bill directly to research in the universities. The pirates claim it would be provide more funds for research, spurring it to produce more results. The pharmaceutical companies would not need to do the research themselves, nor would not be any need for medical patents, as they would have no research costs to recoup. The price of medicines would drop when manufactured in a competitive market rather than by patent protected monopolies.

Patents are seen as making drugs inaccessible to developing countries, forcing their governments to use expensive patent drugs instead of generics. In this issue the pirates are close to the demands made by NGOs, such as Médecins Sans Frontières, to seize patents and extend compulsory license programmes.

Price controls are an impediment to European research. Pharmaceutical companies need higher-paying American consumers to recoup their cost. European consumers and governments benefit from price controls in the short term but in the long term, they suffer. New medicines sometimes no longer reach European consumers, hurting public health; and Europe is losing many quality R&D jobs.

The character of research in the universities has changed. The project to discover a gene affecting the course of a disease or foetal development, is quite different from one testing whether a molecule can function effectively and safely as a drug in patients. An increasing amount of preclinical research is done by young small companies, commonly originated in academy. These small businesses are created around a vital patent. If they have a promising medication in the pipeline they are often acquired by larger corporations for their patent. It is generally a mutually beneficial arrangement, the smaller research company cannot afford the costs for the Phase II and Phase III trials, while the big companies obviously cannot follow all leads in preclinical research.

The most expensive phase is not classical research, but rather the clinical trial. Patents are intended to compensate companies that spend the time and resources to test whether a drug is safe and effective, in comparison with those who only produce and sell medicines.

If patents are removed and commercialization pressure remains, might scientists become even more secretive and firms more aggressive?

In many respects, patents are just a tool in the commercialization process. How many of the documented issues associated with commercialization and industry involvement will go away if patents are banned? Some might even get worse. The Pirate Party's policy might have the unintended consequence to strengthen the position of 'Big Pharma'. By removing patents, the companies concentrating on preclinical research would be choked. Pharmaceutical companies would be required to fill in the gap, while getting even more in league with the government's controlling bodies.

The problems surrounding public health in poorer countries are rather about poverty, the prevalence of counterfeit drugs, lack of trained personnel and poor medical infrastructure. Rather than seizing patents and trying to shoulder the manufacturing burden alone, developing nations should take full advantage of the drugs being given away or discounted by the patent holders themselves.As chronic diseases become more prevalent in lower- income countries, it is vital that the quality of medicines is not sacrificed in a clinically irrational promotion of generic medicines. The differential pricing schemes pursued by some producers seems like a viable way of improving access while maintaining quality, as do properly administered voluntary licenses for generic production.

Venues such as medical prize funds, micro-loans and reforming pharmaceutical subsidies seem as a more appropriate first step. It does not provide all the resources needed for the small research companies, but can do a lot of difference for young researchers.

In a few weeks the Swedish Pirate Party will receive a second MEP, Amelia Andersdotter, due to the final ratification of the treaty of Lisbon. As Ms. Andersdotter has expressed her particular concern about pharmaceutical patents, it would be a good opportunity to find new approaches or at least first do no harm.

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