The UK government has been given a stark warning about its reliance on overseas manufacturers for its pharmaceutical ingredients as the country prepares to deal with the twin perils of Brexit and the coronavirus second wave.
Pharmaceutical drugs
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According to FT, the director-general of the British Generic Manufacturers Association, Warwick Smith, said that the UK only barely met demand for crucial medicines during the peak of the first wave of the pandemic and called on the NHS to reverse the stock reductions, made in the name of efficiency, of recent years.
Over 75% of pharmaceuticals used in the NHS are generic, rather than branded, including most of the drugs used to treat covid patients in intensive care during the first surge of Covid-19. Nonetheless, the generics sector has never received the level of government attention as the branded one, which it considers vital for job creation and research and development.
Smith urged the government to develop a coherent strategy for the generics sector, saying that Covid-19 had put a spotlight on the fragility of the supply chains on which it relied.
Dealing with the high number of coronavirus cases in the UK has created a massive spike in demand for medicines which, in normal times, were only required in small volumes. For many of these medicines, there were “few manufacturers, not many batches a year made — almost the most difficult thing you could think of to ramp up quickly”, Smith said, adding that there had been times when supplies were close to running out.
Mr Smith did however also offer praise to the UK government for managing to build a stockpile of medicines that were difficult to get hold of during the first wave “faster and more efficiently than any other country or region that I'm aware of”, noting that the EU had issued a similar tender process but had issues no contracts.
His calls on the NHS to retain more stockpiles of medicines was a response to the efficiency review that took place several years ago, which led to reductions. Smith went on to suggest that three months of critical medicines should be readily available at all times.
“It's not just about building more factories in the UK; it’s about having a greater volume of critical medicines in the supply chain, it's about procurement policies not just looking at price but security of supply, and it’s about having geographically diverse sources of medicines and their ingredients,” he said.
According to Smith, only 20 to 25% of generics used by the NHS were made in the UK, with 40% coming from the EU. The majority of active pharmaceutical ingredients (API) come, however, from India and China, which had created problems during the first coronavirus wave when factories were shut down and borders closed.
He also said that even if a post-Brexit trade deal could be secured, supply chain delays could still arise.
“The customs procedures at the borders will still be different and more complex,” he said. “The main issue that is not wholly within the government's control is getting . . . [them] running as slickly as possible and that will take time.”
Smith said that the six to 12 months API that many companies had when the pandemic struck earlier this year had now dwindled. making a strong case for government action to build up reserves.
With regard to the UK post-Brexit, he said that the country could create a niche for itself by offering "more simplified, innovative regulation" of generic medicines.
This is something already being considered by UK regulator, the Medicines and Healthcare Products Regulatory Agency. The body was considering the creation of an easier process for the licensing of "biosimilars" - copies of biologic drugs that are cheaper to produce as they have no copyright and that have saved millions for the NHS since they were introduced a few years ago.
“If you put this into the post-Brexit context, what we have to do is make sure the UK remains an attractive market for the pharma industry,” he said.
The UK Department of Health and Social Care said: “We are already working closely with partners across the health system to put in place robust measures to secure UK medicine supply. This includes planning for the end of the transition period, taking into account extra winter and Covid pressures.
“As part of these plans, we have asked suppliers to stockpile, where possible, to a target level of six weeks’ total stock on UK soil.”
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