Eimear O’Leary
Director of Communications and Advocacy, IPHA
Medicines allow people to live longer, healthier lives. They prevent chronic illnesses, improve survival rates for many diseases, combat obesity and improve mental health.
Medicines bring additional health benefits by releasing other healthcare resources, which helps with hospital waiting lists and overcrowded GP clinics. However, for this to happen, a medicine needs to travel a long road — from bench to bedside.
Medicines R&D requirements
The research, development and approval process takes between 10 and 15 years, costing about €2.13 billion. For innovation and medicines development to flourish, predictability and stability within the biopharmaceutical research environment are required.
Central to this is intellectual property (IP) rights, which protect innovative companies’ investment and incentivise the development of new medicines. One such incentive is Regulatory Data Protection (RDP), currently the source of much debate arising from the European Commission’s proposal to cut the current baseline period of RDP from eight years to six years, with conditions on how to achieve the further two years.
RDP enables pharmaceutical innovation
Industry shares the goals of the European Commission, as outlined in the EU Pharmaceutical Legislative package, of providing equitable access to medicines throughout EU Member States while ensuring that Europe can be a world leader in medical innovation. However, cutting the period of RDP has the potential to cause a loss of competitiveness and lead to fewer new medicines being available to Europeans.
R&D is already leaving European shores. In the 1990s, half of all new treatments originated in Europe, that figure is now just one in five. In 2002, the US spent €2 billion more than Europe on pharmaceutical R&D. Today, the US is spending €25 billion more. This means fewer opportunities to participate in clinical trials; longer delays in accessing innovative medicines; and a loss of know-how.
Stable and appropriate RDP is key to long-term investment in medicines development. A robust and innovative EU pharmaceutical industry is essential for Europe’s ambitions to combat cancer, address public health challenges (like antimicrobial resistance and Alzheimer’s) and prepare for future pandemics.
