BIOTECH FINANCES – Proposed revision of the European pharmaceutical strategy and orphan drugs: a project which will impact badly our industry in Europe.
Cedric Moreau, LSAA Executive Board Member and Partner at Sofinnova, and Christian Pierret, LSAA Advisory Council member and former Minister of Industry & SMES, were video interviewed by Jacques-Bernard Taste, chief editor of French media BiotechFinances.
Cedric Moreau highlighted that the current European Commission’s draft reform provides for a reduction in the period of market exclusivity for orphan drugs from 10 years to 9 years for new active substances and from 10 years to 5 years for well-established orphan products. He shared his concerns about the critical vagueness of the definition in this proposal regarding well-established orphan drugs.
He added that while this project aims to accelerate the development and availability of orphan drugs to rare disease patients, the effects of reducing the exclusivity period could be counterproductive and present several risks:
– A slowdown in innovation and the loss of Europe’s leading position in orphan drugs
– Deterioration in access to new therapeutic solutions for patients
– Acceleration of the brain drain to Asia and the United States
These risks were demonstrated in the United States following the implementation of the Inflation Reduction Act, which reduced market exclusivity for small molecules and biomedicines. These perverse effects run counter to the strategies deployed by France and Europe to accelerate innovation in biotechnology and research on rare diseases and orphan drugs, such as the Health Innovation 2030 plan, the National Plan for Rare Diseases (PNMR) and the European Therapeutic Initiative for Rare Diseases (ERDITI).
Christian Pierret highlighted that the current project would create even more uncertainty. He pointed out that on average 1 new molecule put on the market follows 1 billion invested, 10 years of work and 10,000 tested molecules. A new molecule is a long process where research puts the patient at the heart of the process. In health, the investor assumes higher capital risks than in other economic sectors. He has to renew a major financial effort several times. He explained that investors in Europe are exposed to fierce competition with the USA, South Korea, China and India in the future: the capital available there is greater, on average 2 to 3 times greater per round of financing.
He encouraged the EU Commission to change its current pharma package project with a strong protection of intellectual property, patents and data, to secure risky investments. He called the EU Commission to put the patient at the heart of innovation. Read more here. To watch the interview please click below or here.