International approaches to enhancing access to medicines during the COVID-19 pandemic

The COVID-19 pandemic has brought a range of significant challenges to the global community, which require the mobilisation of efforts in politics, economics, technology, science, and law. To expedite the containment and conquering of this pandemic, large-scale worldwide production and equitable distribution of vaccines are essential. However, this goal is currently inhibited to a large extent, by the politics of ‘vaccine nationalism’ of wealthy countries and is a priori aimed at achieving business results for the benefit of transnational pharmaceutical companies. Some countries are implementing measures akin to war by insisting on the production and supply of vaccines and medicines for their domestic needs and prohibiting export. In January 2021, the European Union implemented vaccine export restrictions, which were relied upon by Italy to block the export of Oxford/AstraZeneca vaccines to Australia. Also, the decision of the European Commission of 24 March 2021 concerning the strengthening of controls over vaccine exports does not look optimistic. The latter has introduced the principles of ‘reciprocity’ and ‘proportionality’ as new criteria to be considered for authorising exports under the transparency and authorisation mechanism for COVID-19 vaccine exports.^[1] Recently, several producers in India that manufacture AstraZeneca and Johnson & Johnson (‘J&J’) vaccines warned that the production of vaccines worldwide is under threat because of the US export control during the pandemic. On 25 March 2021, India introduced a de facto ban on vaccine exports, forbidding the world's largest vaccine manufacturer, the Serum Institute of India, from exporting its vaccines, and prioritising local vaccination due to the sharp increase of coronavirus infection in the country. These factors indicate that there are considerable threats to the expansion of vaccine production in the world and their fair distribution.

Therefore, it is important to consider what instruments are available to national governments, including the Ukrainian government, to ensure access to vaccines for their populations. This is especially important when some vaccine manufacturers refuse to voluntarily license their vaccine technology to other companies, thwarting governments' plans to rapidly vaccinate their populations to overcome the pandemic. For example, Biolyse, a Canadian manufacturer of anticancer drugs that can produce two million doses a month and which therefore has the potential to increase global vaccine production capacity, recently sought to manufacture and export the J&J adenovirus vaccine to developing countries. However, J&J refused to license its technology to Biolyse.^[2]

This article will discuss how pharmaceutical companies utilise intellectual property rights to protect their own commercial interests, which may lead to restrictions on vaccine production and access. It will also analyse certain legislative changes by several countries that are aimed at limiting such negative effects on access to vaccines. In particular, patents and other exclusivities are some of the key reasons that may hinder the expansion of the COVID-19 vaccine production and distribution. There is a legitimate concern that pharmaceutical companies will seek to protect their commercial interests in this crisis, to the detriment of public access, which is already happening. Pharmaceutical companies are actively patenting their developments, including vaccines, which means that they fully control the production, distribution, and overall access to these therapies by different countries. This is even though the development of many vaccines and medicines against COVID-19 were heavily subsidized by public funding. Back in March 2020, in anticipation of possible (and, as experience with access to life-saving medicines shows, fairly expected) problems with access to medicines and vaccines against COVID-19, some countries began to take certain measures to prevent situations in which patents and other exclusivities would create barriers to access. This includes amendments to the law in relation to such mechanisms as compulsory licensing and government use.

What are compulsory licensing and government use?

While patents grant exclusive rights over an invention, the exercise of such rights by the patent owner may be limited based on public interest, including for the protection of public health. International law contains specific mechanisms, such as ‘compulsory licenses’, which limit the exercise of exclusive patent rights. A compulsory licence is a permit issued by a government agency that allows the recipient to use the invention without the consent of the patent owner. This mechanism is perfectly legal and corresponds, in particular, to Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS’). It is implemented in most jurisdictions around the world.

A specific type of a compulsory licence, which is also envisaged in TRIPS, is the so-called ‘government use’ or ‘public non-commercial use’, according to which the state grants permission to use a patent for its own use by granting permission to a government agency or even a private entity. The effectiveness of this mechanism is manifested in the fact that the government is not obliged to send a formal request to the patent owner but can act on its own initiative to address specific issues, including public health. This means that governments do not need to spend time negotiating licences, as required by TRIPS for a conventional compulsory licence,^[3] and can use this mechanism when they deem it necessary.

However, the compulsory licensing mechanism is used rather rarely. Among a relatively small number of compulsory licences, the majority were issued by developing countries that could not meet the needs of their populations for the treatment of serious diseases such as HIV, hepatitis C and cancer due to high prices. Since the adoption of the TRIPS Agreement and before the pandemic, developed countries have used this mechanism only a few times. However, it attracted close attention during the pandemic. Some countries have already granted compulsory licences/government use of medicines for their use in treating patients with COVID-19. For example, on 18 March 2020, the Israeli Minister of Health issued a permit to the state to import Kaletra (produced by Abbvie) for the treatment of patients with COVID-19. Other countries are also amending their national legislation to make this mechanism more effective and to ensure that compulsory licensing is granted swiftly when necessary. Such countries include Germany and France. These legislative changes are particularly interesting because, as was mentioned above, these mechanisms are mainly employed by developing countries, while developed countries avoid any categorical actions in relation to pharmaceutical patents.

Legislative changes in Germany 

Under the current regime, the German government may allow the use of patents in accordance with Article 13 of the Patent Act. The Federal government has the right to allow the use of patented inventions in cases where the interests of public welfare or national security are affected.^[4] To make this mechanism more effective during the pandemic, on 28 March 2020, the Law on the Protection of the Population in the Event of an Epidemic Situation of National Importance, the so-called ‘coronavirus crisis package’, entered into force and amended several existing laws. Among other things, this law amended the Act on the Prevention and Control of Infectious Diseases in Humans and added Section 5, which gives the Ministry of Health additional powers to control the epidemic situation, including the power to grant patent restrictions under Section 13 of the Patent Law. The main difference with regard to Article 13 of the Patent Law lies in the competence; that is, the issuance of compulsory licences is the competence of the Federal government under Article 13. These changes have delegated such competence to the Federal Ministry of Health, which may speed up the grant of a compulsory licence.

Legislative changes in France  

France has taken even more drastic measures. Under current law, a number of articles in the French Intellectual Property Code provide the legal basis for compulsory licences. In particular, the so-called ‘license d’office’ may be issued by the ministry responsible for industrial property in the interests of, inter alia, public health, the national economy or national defence.^[5] However, the complexity and length of the consultation and decision-making process envisaged by the compulsory licensing mechanism make it unsuitable for the current crisis. Therefore, to make this process faster and more efficient, France adopted certain changes to this legislation.

While France did not implement any specific changes to patent law in response to the pandemic, on 23 March 2020, it passed the Emergency law № 2020-290 to combat the COVID-19 epidemic, which introduced Article 3131-15 to the French Public Health Code.^[6] Under this new provision, the prime minister has the power, among other things: 1) to order the requisition of all goods and services necessary for the fight against the sanitary disaster as well as any person necessary for the operation of these services or the use of these goods; 2) to temporarily control the price of products; and 3) where necessary, take all measures to provide patients with appropriate medicines for the eradication of the health disaster.

Although this new article of the French Public Health Code does not directly address patent issues, it provides broad powers to the prime minister and may allow, among other things, the ordering of the production of the generic version of a medicine before the patents that protect it expire.^[7] Specifically, this provision may provide the basis for granting a compulsory licence of patents (and potentially even of patent applications and supplementary protection certificates) because it applies, in general, to ‘goods’ and ‘all measures’.^[8]

To date, neither Germany nor France has issued any compulsory licences under these provisions. However, given that the situation regarding access to vaccines in the EU is currently extremely tense and there are already some discussions and public statements by politicians about restricting patents to remove barriers to accessing coronavirus vaccines, the use of this mechanism may very well be possible. Ukrainian patent law also has specific provisions related to compulsory licensing. However, these provisions need to be revised to ensure rapid access to COVID-19 vaccines and medicines. The changes in the legislation of Germany and France can serve as a good example for developing changes to Ukrainian patent legislation on compulsory licences, as well as legislation related to the protection of public health in Ukraine.

(Grateful to Bogdan Gurgula for constructive advice and comments).

[1] European Commission press release, ‘Commission strengthens transparency and authorisation mechanism for exports of COVID-19 vaccines’ (24 March 2021) <https://ec.europa.eu/commission/presscorner/detail/en/ip_21_1352>

[2] Arianna Schouten, ‘Canada based Biolyse Pharma Seeks to Manufacture COVID-19 Vaccines for Low-Income Countries, may test Canada’s compulsory licensing for export law’ (12 March 2021) <https://www.keionline.org/35587>.