After COVID-19, government officials around the world face unprecedented decisions about when and to what extent they must open their own business before effective antiviral drugs or vaccines are developed, only with obtaining and taking authorizations. regulatory requirements. Decisions for public use. In essence, these decisions will require a delicate balance between protecting public health and promoting economic growth, which, as we all remember this year, is closely related.
Particular attention should be paid to how national patent regimes can influence this balance. Under normal circumstances, a robust and efficient patent system can encourage pharmaceutical companies and researchers to invest heavily in research and development to discover and produce important drugs. At the same time, patent rights give pharmaceutical companies a temporary monopoly on development, production, and sales, which can lead, among other things, to higher prices and limited access to essential drugs.
At the international level, the World Trade Organization plays a central role in the discussion of patent law and access to essential medicines. The 1995 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the “TRIPS Agreement”) requires WTO members to grant patents, including patents for essential drugs, for at least 20 years. At the same time, the TRIPS Agreement gives the green light to various instruments for resolving public health problems, including the approval of compulsory licenses in accordance with Article 31 of the TRIPS Agreement. Several countries have already enacted emergency laws to approve larger compulsory patent licenses in response to the current pandemic.
Canada recently passed the Emergency Response Act COVID-19, which authorizes the Commissioner to grant the Canadian government or other applicants a compulsory license to manufacture, use, and sell a patented invention if the Secretary of Health believes that public health exists. . An emergency of national interest, like the new corona virus. Although the patent owner must receive compensation for “the amount the Commissioner considers reasonable in such circumstances”, the Canadian government is not required to negotiate such payments or other terms with the patent owner. Germany recently passed the law for the prevention and control of infectious diseases in humans, which in particular grants compulsory authorization to the Federal Ministry of Health.
Israel was the first country to recently introduce this right by granting a compulsory license to import a generic version of Kaletra, a combination of two antiviral drugs commonly used to treat HIV. Patent holder. Israel’s treatment needs cannot be adequately addressed.
Under the test
Some other countries, such as France, Chile, Ecuador, and Australia, appear to have recently resolved compulsory licensing issues through new laws or are considering similar measures. So far, the United States has not indicated that they will do the same.
Mandatory licenses may not be enough to ensure that key medicines are produced and sold at an affordable price to the general public around the world. Voluntary patent groups, including the recent Costa Rican government initiative launched later this month, can be an effective tool to fill the gap around the world. According to the proposal of Costa Rica, which is supported by the World Health Organization, countries, companies and universities will create a central repository of their intellectual property, which will subsequently be available worldwide. The private sector has entered into force. An important area of activity is the Open COVID Commitment, which encourages patent owners to make their intellectual property freely available in order to end the COVID-19 pandemic and minimize the impact of the disease. Although the promise is completely voluntary, technology giants such as Microsoft, IBM, Intel and Amazon have grown among its founders, and AT&T and others have signed up for the promise.
However, pharmaceutical companies that invest heavily in risky research and development generally have not agreed to openly authorize their patents and other intellectual property rights. More recently, a bill introduced by Senator Ben Sass (R-NE) called the Coronavirus Innovation Promotion Act suspended these patents in a state of emergency and would therefore extend them. of these patents. Patents for another 10 years.
However, it remains to be seen whether this conflicting proposal will become law on how this legislation is still in its infancy.