Drug development model 'must be replaced'

This is the controversial view put forward by Tim Hubbard of the Wellcome Sanger Institute in Cambridge, UK, and Jamie Love of Consumer Project on Technology (CPTech) in Washington, US, in an essay published in the February issue of the Public Library of Science's PloS Biology​ journal.

"Drugs are too expensive and are beyond the reach of many people in the developed as well as the developing world,"​ say the authors. The millions of people with HIV/AIDS around the world who are unable to receive any treatment - which has brought access to medicines to the public notice - is "a morally offensive outcome,"​ they write.

The inadequacies in the current system, suggest Hubbard and Love, are a consequence of a business model that uses a single payment to cover both the costs of manufacture, marketing and sales of a drug and the cost of R&D carried out by manufacturers to discover it.

The current system is supported by a vigorously enforced intellectual property regime, which protects the financial interests of companies and reaches across borders so that poorer countries cannot develop cheaper versions of the drug, they add.

Aside from the inadequate availability and high price of drugs, other unwelcome side effects of the existing business model are a lack of information sharing among researchers, and a consequent reduction in the pace of discovery. There are also strong incentives to develop drugs that have little, if any, increase in efficacy over existing drugs - so-called 'me too' drugs.

"It is not surprising that many of the major global health challenges, which tend to affect poorer nations, receive short shrift from companies that focus their attention on more lucrative health markets,"​ they suggest. Companies focus on passing high prices on to fewer patients, rather than maximising the number of individuals treated.

The argument often levelled by the drug industry is that long patents are required to recoup the investment in medicine development, and that without this exclusivity R&D into new medicines will not occur. But there are practical alternatives to this model that could also work, argue Hubbard and Love.

For example, the markets for R&D and the markets for products should be separated, with researchers and drug developers compensated not through a marketing monopoly but via other means. Large cash prizes could be paid to successful firms or non-profit drug developers, and direct public sector involvement in drug development, new open collaborative development models, or government imposed research mandates would be possible economic models for funding drug development.

Money could be raised and managed through taxes and traditional government institutions like the US National Institutes of Health, or through 'bottom up' mechanisms such as employee contributions to competitive intermediates that fund R&D - analogous to pension funds - or through other approaches.

Such a system would reduce the influence of intellectual property rights, and lead to much greater openness in the area of drug research, claim the authors. Competition would still exist for the manufacture and distribution of drugs, but prices would inevitably drop.

There are many obstacles and challenges to the development of the new drug R&D market, but Hubbard and Love believe that the economics can be worked out.

"We can raise global R&D levels as a matter of policy and ensure that resources flow into the areas of the greatest need, and we can do so knowing that the poor and the rich will have access to new inventions at marginal cost,"​ they conclude.

Hubbard and Love's article is available to read in full on the PloS website​.