President Jair Bolsonaro sanctioned on September 2nd the Bill 12/2021, that allows the compulsory licensing of patents on vaccines and medicines to face public health emergencies. The Bill 12/2021 amends Law No. 9.279, of May 14th, 1996, which regulates rights and obligations related to industrial property.
However, Bolsonaro vetoed provisions that forced patent owners to share information, data protection results, technical know-how and biological material for medicines and vaccines. He also vetoed that, in the specific case of public health emergency of national or international interest, the compulsory license may be granted by the National Congress through law. Now the National Congress can maintain or overturn presidential vetoes.
The Brazilian Congress has been discussing the compulsory licensing of vaccines and medicines to combat Covid-19 since the beginning of the year. At the end of April, the Federal Senate approved the Bill 12/2021. The text was approved with amendments by the House of Representatives in July and, before proceeding to presidential sanction, was analyzed again by the Senate.
Since the beginning of the process of the project, Interfarma has met with representatives of its associates who have vaccines or medicines used in the combat against COVID-19 to discuss the strategies to be adopted by the entity in the National Congress.
Interfarma has been woking with members, international organizartions including PHRMA, IFPMA and engaging Embassies to help advocate at the National Congress concerning the risks of the bill, if the vetoes are not maintained. Interfarma has also engaged with leaderships in the Senate and Lower House, aiming to assure that the vetoes of the Executive are kept by the legislative. This is crucial for the maintenance of a robust IP system in Brazil.
What determines the Bill
The sanctioned text determines that the Executive Branch must publish a list with the patents or patent applications to be compulsorily licensed within 30 days from the date of publication of the emergency or public interest statement. Any public or private institution may apply for inclusion of a patent or patent application in the list.
The holder of the patent or patent application subject to compulsory license shall be remunerated at 1.5% of the net selling price of the product.