“Here everything has two sides and clearly consumers would benefit from reducing costs and access to medicine, but on the other hand we can understand that compulsory licenses would be like a punishment for the creator, when in Colombia there is price control and that is how it should be treated,” the expert concluded.
University of the Andean Area
In the realm of intellectual property and the pharmaceutical industry, there is an ongoing debate on access to essential medicines and patent protection. One legal tool that has generated controversy is the implementation of compulsory drug licences, a mechanism that allows governments to grant third parties the right to manufacture a patented drug without the consent of the patent holder.
Recently, the Colombian Ministry of Health, through resolution 881 of 2023, stated its intention to declare a compulsory license for the compound ‘Dolutegravir’, the main active ingredient in an antiretroviral for the treatment of HIV, citing reasons of public and national interest.
To understand more about the subject, the law firm Posse Herrera Ruiz, in its most recent podcast episode, was investigating and discussing this recent controversy. Mónica Bonnet, associate of the Intellectual Property team, explained some implications that this has for both the manufacturing laboratory and the consumer.
What are compulsory licences?
Compulsory licenses are a measure established in intellectual property legislation that allows a country’s government to grant a third party the right to use a patent without the permission of the patent holder. These licenses are applied in exceptional situations, such as public health emergencies, excessively high drug prices, or when the patent holder cannot satisfy the demand for the drug in question.
“The patent holder has the right to license, however, it has some limitations that are called ‘compulsory licences’, and that can be requested by a third party or declared ex officio by the competent national authority”, Bonnet explained.
Legal effects and controversies
According to the lawyer, the implementation of compulsory drug licenses can have various legal effects and has been the subject of intense debate. On the one hand, its main objective is to promote access to essential medicines, especially in developing countries that do not have the capacity to produce or acquire them at affordable prices due to patents and the high associated costs.
However, this measure has raised concerns among patent holders and pharmaceutical companies, which invest large sums of money in research and development of new drugs. They argue that compulsory licenses can discourage innovation, as drug makers may have less incentive to invest in research if their patents can be licensed without their consent.
“In Colombia there were no compulsory licenses, the laboratories that are generators of knowledge and innovation and that patent, invest many millions of dollars to achieve patenting. Also, the sanitary registry is another great effort from the point of view of confidential information and ‘know how’”, he stated. And he added: “The declaration of a compulsory license of a patent can discourage the production of research and the arrival of foreign investment in Colombia. The value of a patent is that it protects the invention on which that property is declared. It excludes third parties from exploiting it commercially, that is the privilege of having it”.
Photo: USIL Blog
consumer and access
These types of measures in medicines are mainly aimed at guaranteeing broader and more affordable access to vital treatments. By allowing third parties to manufacture patented medicines, governments can increase the availability of these products and reduce their cost, which can be crucial in treating serious diseases and improving public health.
However, according to Bonnet, the implementation of compulsory licenses must be done carefully to avoid potential conflicts with intellectual property rights. In addition, it is important to establish safeguards and control mechanisms to ensure that licenses are used appropriately and fairly, and are not abused.