Sir, – It has become clear that there is a shortage of Covid-19 vaccines, not just in Europe but also across much of the world, leading to the proposal to suspend intellectual property protection on vaccines to allow other companies manufacture them. However, not only will this not resolve the issue it could even make things worse.
Making a generic version of a small-molecule drug is relatively simple. The patent describes the structure and synthesis of the drug and the generic company simply has to show that their molecule is identical and confirm that their version delivers the same amount of drug in a small number of healthy volunteers, ie bioequivalence. However, bioequivalence does not work for large molecules such as proteins, as trying to prove that they are identical is extremely difficult.
Furthermore, because of their size, they could differ but still be equally as effective. This led to the concept of biosimilars, which requires generic manufacturers to show that their product has no significant differences in structure and also demonstrate the same clinical benefit.
Generic manufacturing of vaccines is challenging – 15 million doses of the Johnson & Johnson (J&J) vaccine were destroyed because of errors in manufacturing in one of their sub-contracting facilities and this would have been under the supervision of J&J engineers.
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India-based Ranbaxy was one of the biggest manufacturers of generic medicines in the wold and in 2014 was fined $500 million by the US government for selling adulterated medicines and banned from selling in the US.
Would we be happy that the developing world was to be supplied with sub-standard vaccines that are not as effective or with a higher rate of adverse effects?
Rather than generic manufacturing, it is more effective for pharma companies to license out manufacturing to other facilities.
However, there is a shortage of such facilities and those that exist are already producing important drugs.
For instance, Pfizer’s facility in Grange Castle in Dublin makes Enbrel, an important drug for rheumatoid arthritis. Do we stop providing Enbrel for these patients?
In reality, any company with a bio-pharma manufacturing facility that is fully equipped and staffed can easily get a contract to manufacture a Covid-19 vaccine, it is just that there are very few of them. – Yours, etc,
Prof DERMOT COX,
School of Pharmacy
and Biomolecular Sciences,
Royal College of Surgeons
in Ireland,
Dublin 2.