Access to Medicines - are generics the answer?

The IBA is trying to resurrect the committee on Law and Medicine under the hardworking leadership of Nick Kirby. The workshops at this year’s conference were not that well attended but generated lively debate and have set up a good basis to move forward. In particular areas of specific concern have been identified for follow up. I took part in the panel on access to medicine in relation to generics. Unusually the panel was primarily made up of people from the generic side of the industry and I was the only speaker to represent the research based industry. Rather than go through the usual arguments defending patents which I felt would probably not be of much interest to the audience, although I do feel that there are real problems of bias and hind sight in the some judgements where patents are attacked many years after grant, I decided to look at the bigger problem of the enormous costs of developing new drugs and the regulatory issues that delay or impede their early distribution. Generics may offer cheaper treatments than branded products but will by their nature be older drugs and often newer treatments may be more effective.

The enormous costs of developing new medicines mean that only the largest companies can bring them to the market preventing new commercial entrants and of course bias funding towards those indications with the most substantial potential returns. These high costs need to be recovered as do the costs of all the failed projects which push the price to consumer or health provider artificially high to the detriment of all. This suggests that more should be done to reduce these original costs. As the highest costs are incurred late in the development process the more that can be done to allow the best compounds to be selected early on the greater the savings that could be made. This suggests that greater investment in effective screening technologies and replacements for expensive and inaccurate animal testing would really pay off. Although suggesting more government funding in the current climate seems quixotic I think this really could be a usful long term investment that would stimulate G8 jobs and make more medicines available for everyone. The more we could understand at DNA/ cellular stage too the more accurately we could predict in which population types the treatments would be likely to be effective.

Government will in combatting disease is also important. We have seen how determination has led to the eradication of small pox and now, this week, rinderpest. The eradication of leprosy seems a genuine possibility and at a more local level Uganda has shown how AIDS cases can be drastically reduced. More can still be done in agreeing common regulatory standards and in ensuring efficient distribution.

Some diseases of course remain woefully neglected. I serve as a director of a Scottish based charity, St Andrew’s Clinics for Children,, which provides basic healthcare for children in sub-Saharan Africa and we are particularly concerned about worm infestation. Of all the world’s neglected diseases the incidence of worm infestation dwarfs the others and yet no new treatments have been developed in recent years. Generally treatments are developed for livestock and then screened for potential use in humans however increasingly pharmaceutical companies are spinning off their animal health businesses and this screening no longer seems to be standard practice. We are already seeing resistance in livestock so it can only be a matter of time before this becomes a major problem for human health too.

What can be done to tackle neglected diseases like the worm issue? The commercial potential is limited as most of the individuals affected cannot afford to pay for expensive medicines but some creative solutions have been proposed. We have seen a growth in not for profit development companies, primarily but not solely focussed on malaria while the US is offering an incentive for companies to get accelerated review of their next product dossier if they register a new product for a neglected disease. Open innovation may be a way forward too ( see my previous post: Patents – heading for expiry?) where knowledge is pooled in different ways. The GSK malaria project has been well publicised but a group of companies are cooperating on an interesting TB initiative too while in Scotland we may be moving towards a counter to the big company approach by bringing together our veterinary and medical schools to work more closely.

We have a lot to think about in how we priortise work for the committee and we are keen to take the discussion beyond the legal community by involving a range of interested parties both in the next conference and in the ongoing work. It is important to everyone that we use the talents available to make a difference and not just to form a talking shop.

< back to Blog