In response to a request for evidence in April 2022, the European Commission commenced a public consultation in July 2022 with the purpose of amending the rules governing the compulsory licensing of patents in the EU. The main objective is to provide a less fragmented and more effective compulsory licensing system for crises affecting the entire EU, whether they be industrial, nuclear, or related to health. However, the consultation recognizes that any system should remain exceptional and a last-resort measure, applicable in the lack of voluntary agreements and keeping in mind that forced licensing may have a substantial impact on IP holders.
The European Commission has launched a public consultation on the compulsory licensing of industrial property rights
In particular, the European Commission singles out the health sector (including generic manufacturers, start-ups, and patient associations) and the EMA in its request for responses from relevant stakeholders, including all sections of the IP community (IP rights holders, users, lawyers, and IP offices). The Commission is primarily seeking contributions for the following areas:
- insights on each country’s national regime on compulsory licensing;
- specific proposals for creating a cohesive, fair, and effective EU legal regime on compulsory licensing;
- proposals for limiting the risk that the mechanism be trivialized in the future such that it only be used as a last resort; and
- proposals for alternative mechanisms that would achieve the same outcome.
The consultation’s objective is to gather opinions from all interested parties in order to comprehend the various grounds and procedures available for issuing compulsory licensing in a crisis in EU member states, such as the COVID-19 pandemic, to spot constraints and the effect on such a system’s stakeholders. The effect analysis on compulsory licensing will be strengthened by the consultation.
A debate about whether waiving intellectual property rights is the most effective way to fulfill the demand for COVID-19 vaccinations throughout the world has occurred as a result of the complexity around the production and supply of vaccines to tackle the COVID-19 pandemic during the past few years. Certain parts of the TRIPS Agreement were waived by WTO members on June 17, 2022, at the 12th WTO Ministerial Conference in Geneva (MC12), allowing countries to use patents relating to the production and distribution of COVID-19 vaccines without the patent holder’s consent. However, the countries must pay the patent holder “adequate remuneration.”
The conclusion of the MC12 meeting has disappointed inventors and innovative businesses. The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical sector, has criticized the decision as a step backward in the sector’s joint capability to tackle the COVID-19 epidemic and upcoming threats to world health. Additionally, EFPIA has stated its opinion that the decision “sends a dangerous signal not only to the pharmaceutical industry but to all innovative sectors. Dismantling the very framework that has brought solutions to tackle COVID-19 and facilitated the unprecedented number of partnerships, voluntary licensing, and knowledge-sharing taking place during this pandemic in record-breaking time, can have ripple effects for the future”.
Against this scenario, the European Commission’s announcement of a public consultation offers an excellent forum for all interested parties to participate in a conversation and give recommendations in order to achieve a more harmonized, consistent, and workable framework for compulsory licensing. Even if EU harmonization is accomplished to some extent, any new regulation must be TRIPS compatible. Particularly, under Article 31(b) of TRIPS, compulsory licensing is only permitted if the intended user of IP rights has made unsuccessful attempts to seek permission from the rights holder on fair economic conditions and within a reasonable amount of time. So any request for a mandatory license under the new harmonized approach won’t be made right away, even in the event of a worldwide health emergency.
You can find the list of EU IP Firms here.