From the start of the COVID-19 epidemic in Spain, we are experiencing exceptional circumstances that have also impacted on pharmaceutical policy with several actions taken by the Government to guarantee the supply of medicines.
First there was the amendment, of 10 March, to the Law on Special Measures in relation to Public Health (BOE), that gave the Executive powers to centralize the supply of medicines and healthcare products. Not long after that, on 12 March, the Law on Guarantees and Rational Use of Medicines (BOE) and healthcare products was amended so that the Government could regulate the mechanism for fixing the prices of medicines and healthcare products not subject to medical prescription and also establish maximum prices for sale to the public.
On 14 March, the decree declaring the state of emergency, gave the Government the power to intervene and temporarily occupy factories in the pharmaceutical sector; to enforce the orders necessary to guarantee the supply of medicines and products necessary for the protection of public health, and also to adopt special measures in relation to the manufacture, importation, distribution and dispensation of medicines.
The latest such measure was taken this week, on 23 March. Faced with the need for updated data on the availability and manufacturing projections for some medicines considered essential, the Government issued an order in the Official State Gazette (BOE) forcing pharmaceutical companies to provide detailed information and establishing the obligation to supply and manufacture these products.
All of these measures are necessary; however they may not be sufficient in the medium term given the dimensions of this healthcare crisis. Innumerable clinical trials are being conducted to test existing antiviral drugs. The Government must be prepared for a scenario in which pharmaceutical companies cannot guarantee supply – some companies are already warning of this – or where they do so with predatory pricing. Spain would have to explore new formulas, such as compulsory licenses (that is, temporarily suspending the exclusivity of a patent so that the drug can be produced generically) or public production of medicines, as is being carried out at the Military Defence Pharmacy Centre with some medicines and products for the protection of health in this epidemic. Other countries such as Chile and Israel have already opened the door to these decisions.
In Chile, just a week ago, the lower house of Congress approved, almost unanimously, a resolution that will allow the Government to issue compulsory licenses for the use, sale and production of any medicine, vaccine or diagnostic equipment to help combat the pandemic.
Something similar has occurred in Israel, where the Ministry of Health issued a compulsory license that, in light of the inability of the company with the patent to ensure supply, will allow the Government to import genetic versions of Kaletra, an antiretroviral used for HIV that is being used to treat some patients infected with COVID-19 and which is under clinical trial, with results still not conclusive, to assess its efficacy against the virus.
Other countries are already considering amendments to domestic patent legislation to ensure some room to manoeuvre when it comes to fighting the pandemic. Such is the case of Canada, which is considering legislative changes to expedite compulsory licenses; Ecuador; and Germany, which may restrict patents relating to COVID-19. There are also countries such as Australia and Spain which are in favour of “studying the possibility of further exceptions to global regulation of patents, in order to streamline licensing processes and the transfer of technology in order to manufacture certain products throughout the world”.
Many of the new specific treatments that will emerge to tackle COVID-19 and the experimental vaccines being tested will hinge on decisions such as these and, therefore, they are fundamental. It is vital that, where there is sufficient evidence of their safety and efficacy, they are available in any part of the world at fair and affordable prices, thus preventing monopolies or a small number of pharmaceutical companies obtaining exclusive control of bringing these to market, especially where vast amounts of public resources are being invested.
COVID-19 will not end with quarantine and we need to be able to continue to tackle it – as well as other health needs – with all our resources and without placing our health systems at risk.
