Russian patients may not be able to access western drugs
Russian patients may not be able to access medicines developed by multinational pharmaceutical companies
Experts are certain there is a solution
14.09.2022
In the next ten years, about 300 drugs that are under development may not reach the market, including medicines to tackle diseases currently seen as incurable. This was reported by Kommersant, which cited a study by the Center for Mathematical Modelling in Drug Development at the I.M. Sechenov First State Medical University, Moscow. The issue has arisen because global pharmaceutical companies have suspended clinical trials of their drugs in the Russian Federation.
International drugs manufacturers, including Janssen, Novartis and Pfizer, have suspended new clinical trials in Russia since the spring, although completing in-country trials is required for registering most drugs. According to Ilya Yasniy, head of scientific assessments at the venture capital fund LanceBio Ventures, Russian companies will not be able to supply the market with equivalents for all internationally developed drugs.
Elena Gracheva, programme coordinator and board member of the AdVita Foundation, thinks that the problem could be solved by the principle of ‘zero registration’ for Western medicines in Russia. She explained that Russia actually requires pharmaceutical companies to repeat certain parts of their clinical trials within Russia because it does not recognise either European Union or USA Food and Drug Administration certificates.
In the overwhelming majority of cases, companies have now interrupted clinical trials not to make a point, but because some countries have imposed sanctions on scientific cooperation with Russia. In other cases, the main reasons were insurmountable logistical difficulties and high costs.
“If Russia introduces the principle known as ‘zero registration’, when the country recognises certificates issued for a medicine in the USA and/or the European Union, no repeat trials will be required: the pharmaceutical company will simply supply the medicine to the Russian market,” Gracheva told an ASI reporter.
“Talks about simplifying the registration procedure for medicines have been in progress for twenty years; but throughout that time, the government has never come to a decision on whether to authorise innovative medicines solely because they’re already being used in treatments across Europe and the States. Maybe the moment to decide is now. In that case, phasing out clinical trials by Western pharmaceutical companies would have no consequences for Russian patients,” said the specialist.
However, for many patients with life-threatening conditions, clinical trials were the only chance of survival, said Yuri Zhulev, co-chairman of the Russia-wide patients’ union. The fact that no new trials are starting is now tantamount to these patients being doomed. They have no other options for getting hold of modern drug treatments.
Overall, “it’s too early to start panicking yet” said an Altsrus Foundation specialist working at a federal medical facility.
“We’re working with some foreign pharmaceutical companies, and continuing what we started before February. I can also say that, based on my experience with Janssen and Roche, they haven’t stopped their activities in Russia, and aren’t planning to. Of course, we can’t predict anything, but in my opinion, it’s unlikely they will all stop operating in our country,” the specialist told an ASI correspondent.
At the same time, Russian pharmaceutical manufacturers are becoming more active. Domestic drug developers increased their clinical trials for so-called breakthrough therapies by 17% in 2022 compared to the same period for 2021, including for treatments targeting spinal muscular atrophy, haemophilia and other diseases.
