March 12, 2021
COVID-19 and Quality of medicinal products
The pharmaceutical industry has made enormous efforts over the past decades to develop high-quality medicinal products and to produce them batch by batch according to the relevant standards. This development went hand in hand with the specification of approval requirements by the national and international authorities in corresponding guidelines, which pharmaceutical scientists from industry and universities have also contributed to the development of.
The corona pandemic has brought new challenges with regard to the sufficient availability of certain medicinal products and medical devices, which have also brought medical care to its limits in some areas. This applies above all to products whose manufacture has gradually been relocated from Germany and Europe to low-wage countries over the past few decades. But the production of the raw materials required for the pharmaceutical formulation was also affected as soon as these could not be offered at competitive prices under the strict environmental standards in the European Union.
Compulsory Licenses for Vaccines? – Hopes and longings without a realistic perspective
On various occasions in the last few weeks the demand for “compulsory licenses” for patented COVID-19 vaccines has been discovered as a panacea to solve the vaccine shortage. This gives the public the impression – but also the hope – that the deficiency situation could be resolved in the shortest possible time, ideally in days or a few weeks. But would this really be feasible and can such a requirement be expedient? Knowing the difficulties that are generally associated with establishing a pharmaceutical production facility at a new location – on top of that, with such complex processes as the manufacture of vaccines – the perspective associated with this requirement is certainly not realistic.
In view of the enormous efforts that companies have to make to consistently produce drugs of the required quality, setting up the facilities required for this in the short term and, above all, carrying out all the necessary measures to validate the quality is unrealistic. The targeted production of additional vaccine quantities would only be possible after months.
All the more gratifying are the alliances and collaborations between the patent and approval holders of COVID-19 vaccines and pharmaceutical companies to advance research and development as well as approval and to increase production capacities.
Return of pharmaceutical production to Europe
The same also applies to the relocation of pharmaceutical production from the Asian locations back to Europe or Germany, which has been called for on various occasions in the context of the pandemic. This initiative is to be welcomed in principle, but implementation in this case also poses major challenges. It is not just a matter of a simple change of location (there are clear regulatory requirements for this), but other problems arise, such as the question of the availability of identical pharmaceutical exipients and access to the corresponding suppliers. Not in every case – especially not when production is outsourced to subcontractors – this will be possible without a hitch. If, however, other raw materials have to be used and modifications of the manufacturing process are unavoidable, changes in quality could result which in individual cases would even make further clinical investigations necessary.
The Frankfurt Foundation Quality of Medicines will closely follow the developments and actively support the necessary specialist discussion.