Compulsory licensing & access to medicines

Research-based pharmaceutical companies invent, develop and supply medicines that help people live longer and better lives. EFPIA member companies are committed to promoting and improving access and affordability of these life-saving medicines.

EFPIA members share the goal of all countries, including developing countries, to address their health challenges in a practical way. However, this commitment relies on many different actors and factors, especially in low income and least developed countries. Companies have been addressing, over the last few decades, the challenges of access by implementing a range of innovative and durable approaches, including :

  • Donation programmes,
  • technology transfer or product development partnerships, through which R&D-based pharmaceutical companies are helping partner companies around the world to make advanced medicines and vaccines for their local markets. Voluntary license or non-assert policies which provide legal certainty for local producers in starting productionCapacity building initiatives designed to empower local authorities and healthcare providers, to create the necessary framework to prescribe and dispense medicines
  •  pricing policies tailored to the needs of patients and healthcare providers which can be applied within a country (intra-country) or across similar countries (inter-country). Such initiatives are usually summarized under the term “differential pricing” or “tiered-pricing”. Differential pricing links the price of the medicine to the ability to pay of the patient.

Increased reliance on compulsory licensing undermines sustainable approaches to access to medicines and incentives for innovation, notably intellectual property rights: The effectiveness of IP rights is a crucial component of long-term economic development within these countries and an important incentive to develop new medicines.

The 2001 Doha Ministerial Declaration on the TRIPS  agreement and Public Health stresses the importance of interpreting and implementing the TRIPS Agreement in a way that supports public health by promoting both access to existing medicines and the creation of new medicines.

The Doha Declaration further details how TRIPS “flexibilities”, such as compulsory licences, should be interpreted so as to satisfy this two-pronged objective, recognizing that a stable and predictable intellectual property system is important for the development of new medicines but also a facilitating condition of technology transfers and negotiated access mechanisms.