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Developing new drugs

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THE challenges of drug development have been much in the news of late. This interest has been prompted partly by concerns over the proposed takeover of AstraZeneca by Pfizer and the potential consequences for research and the UK economy, and partly by concerns highlighted by the WHO and others about antimicrobial resistance – a problem made worse by the prospect that, with fewer new products in the pipeline, the supply of effective new antimicrobials could be drying up. Although much of the current interest is focused on human medicines, similar challenges exist in the veterinary field: the veterinary pharmaceutical sector has itself undergone a good deal of restructuring over the years, animals are by no means exempt from the consequences of antimicrobial resistance, and the availability of licensed products to treat various conditions in different species has long been a matter of concern (see, for example, p 489 of this issue). In the veterinary field, the problems can be compounded by the fact that, although the market for products may be smaller than in the human field, the costs of development remain high. A recent report from the Royal Pharmaceutical Society (RPS), while also mainly concerned with human medicines, seems relevant in this context.

The report – ‘New medicines, Better medicines, Better use of medicines’ – calls for ‘a new covenant’ to be developed between the pharmaceutical industry and wider society, including government, to speed up and incentivise the development of new types of tailored medicines and treatments. As the RPS explains in a press release, it ‘spells out the advances ahead as well as the limitations of current business models to deal with a future where pharmaceutical companies will no longer be able to rely on “one size fits all” blockbuster medicines for patients’. According to Jayne Lawrence, the society's chief scientist, ‘We are living in an incredibly exciting age, where the human genome is being decoded and scientists are examining how we can cure diseases rather than just offer symptomatic relief. However, the market is not set up to incentivise the production of new types of medicines.’

Among points made in the report is that developing new medicines is a long and arduous process. Most potential drugs never reach the market, with most being discarded during initial screening and with the costs associated with drug failure increasing as the drug moves through the development process. It argues that both the cost and time taken to bring a medicine to market need to be reduced to ensure that the development of new and innovative medicines remains an attractive proposition for companies, and that new funding mechanisms are needed to incentivise drug development while at the same time ensuring that patients receive the best treatments as soon as possible.

The need for new incentives is, it says, particularly true for antibiotics, given that the last new class of antibiotic was discovered as long ago as 1987. However, the incentive for pharmaceutical companies to develop new antibiotics is low due to the poor return on investment they provide. This, it explains, is because (unlike some other drugs) they are not usually taken for long periods and are frequently curative, and because newer antibiotics will need to be reserved for the treatment of infections that are resistant to treatment with other products.

Regarding new technologies, it recommends, among other things, that the public and patients need to be educated about the ethical and moral issues surrounding their use, and that appropriate funding models need to be devised to support their use and development. It suggests that efforts need to be made to streamline and reduce the regulatory burdens associated with the approval of new and innovative medicines, and to encourage participation and transparency in clinical trials. As well as recommendations relating to research and the development of new medicines and treatments, the report includes a number of recommendations for making better use of products that are already available. It also includes recommendations aimed at improving access to medicines globally.

Not all of the issues and examples discussed in the report will be directly applicable in the veterinary field, but many of the challenges sound all too familiar. Unfortunately, while the problems are relatively easy to identify, workable solutions seem harder to find.

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