The UK government should consider changing patent law to incentivise major pharmaceutical companies to develop new antibiotics to address the "grave threat to health" posed by antimicrobial resistance (AMR), Out-Law.com reports a committee of MPs has said. AMR is recognised by scientists as a growing problem – many bacterial diseases are evolving in a way which makes them resistant to existing medicines. If unchecked, this development will pose a health risk to the global population.
In the report, the Health and Social Care Committee in the House of Commons at the UK parliament said the problem of AMR is not receiving sufficient priority and "needs political leadership at the highest level of government". The committee highlighted the fact that "no new class of antibiotics has been introduced for over thirty years" and partly blamed that on "a fundamental failure of the market for new antibiotics".
It identified the tension between the return that pharmaceutical companies expect to see on the investment they put into developing new medicines, which the report said typically occurs in the 20 year period in which the manufacturers of those medicines enjoy exclusivity on the market due to their patent rights, and the push to prescribe antibiotics only "very sparingly" to "preserve their effectiveness for as long as possible".
Developing new drugs is expensive. The costs involved in bringing drugs to market, from carrying out clinical trials, to meeting regulatory requirements, can be prohibitive. The economic case for developing those drugs can be undermined if the market for those drugs is fairly small. Often only a relatively small proportion of the population require access to new treatments for rare strains of diseases showing AMR. The MPs said that patent law reforms should be considered in the UK to "address market failure".
According to their report, the reforms could include extending the life of some patents for new antibiotics or providing for a "transferable patent voucher" which would "grant a patent extension to the successful developer of specified antimicrobials". The patent voucher could then "be used to extend the patent on another product, or could be sold on to another company", it said.
Asawari Churi, a part-qualified patent attorney at UK law firm Pinsent Masons and a former research scientist in molecular biology, said: "The patent voucher scheme referred to in the report, also known as wild-card patent extension, is highly controversial. One of the concerns is that major pharmaceutical companies may use this to prolong the life of their key patents thus keeping drug costs high for much longer, effectively transferring the R&D costs associated with developing new antibiotics to another patient population. No system is perfect, however, and desperate times call for desperate measures. Another solution may lie in orphan drug designations."
The MPs also urged the UK government to pilot a new "upfront payment scheme" to incentivise the development of new antibiotics. The committee said it wants to see "tangible and rapid progress in this area within six months" and that both the government and industry should invest in the scheme.
According to the committee's report, the upfront payment scheme would be analogous to "advance purchase orders" to guarantee drug companies that develop new antimicrobial drugs "a certain level of profitability … within the patent life, even if the product is held back as treatment of last resort and not extensively used".
The UK government and the Association of the British Pharmaceutical Industry have been developing a pilot scheme, but the MPs said in their report that evidence presented to its inquiry suggested that government funding is now needed to "take it to the next stage".
The government should also explore introducing an antibiotic investment charge, as recommended by Lord Jim O'Neill in his report on tackling drug resistant infections globally in 2016, the MPs said. The charge would "be paid by pharmaceutical companies, but with exemptions for those which are participating in antibiotic development", according to the committee's report.
[link url="https://www.out-law.com/en/articles/2018/november/mps-patent-law-reforms-antimicrobial-resistance-/?utm_source=Emerge&utm_medium=Email&utm_content=58ef8e82-bef5-4b43-acaa-2dc90bbb104d"]Out-Law.com report[/link]
[link url="https://publications.parliament.uk/pa/cm201719/cmselect/cmhealth/962/96202.htm"]UK Parliament report[/link]