New Pharma Legislation May Cut Europe R&D Share By One-Third

The European Federation of Pharmaceutical Industries and Associations- EFPIA happens to be consistently applying pressure on the Commission for its pharmaceutical legislation. In a newly published assessment, EFPIA infers that the draft proposals would further speed up the decline of Europe’s position in pharma R&D investment as compared to the US, China, and Japan.

The science infrastructure across nearly all member states would be hit, with Germany expected to face the most significant impact, thereby losing almost €626 million in a year. Belgium stands to lose out on R&D projects amounting to €381 million, while France may very well miss on projects worth €326 million.

As per the data, the Commission’s proposals to lessen the regulatory data protection, which EFPIA claims happens to be important for the intellectual property rights of many ground-breaking medicines, will result in a 55% dip in companies’ incentive to invest in this specific type of drug in Europe in the next 15 years.

As stated by EFPIA, this turns into a major effect on European innovation as well as its competitiveness. The Commission proposals are anticipated to further escalate a trend that has already seen Europe lose one-fourth of its global R&D investment over the last 20 years.

If in case, the proposals remain unchanged, it is predicted that Europe’s share of international R&D investment will go on to dip by a third from its current level of 32% to 21% by the year 2040. This means a loss of €2 billion in R&D investments per year.

It is well to be noted that in Europe, one in five drug development programs that rely on regulatory data protection would go on to become economically unfeasible. This implies that almost 50 out of the expected 225 new treatments would not get developed within the next 15 years.

The proposals will go on to have the greatest impact on biotech SMEs, dipping into an existing situation where Europe’s biotech industry is already moving towards more stable financial ecological systems in the US as well as China.

The European Commission is making changes to the incentives for orphan drugs, a move that EFPIA says will have a disproportionate impact as far as research for the 1.5 million patients with rare diseases is concerned, which could result in the loss of 45 orphan drug programs.

Additional research conducted by EFPIA states that if the definition of unmet medical need is tightened as per the proposal, only 18% of recently made products might go on to meet the criteria with a prominent impact, especially in areas like cardiovascular disease, diabetes, as well as HIV.

In 2010, Europe went on to represent 37% of global R&D efforts, but by 2020, this percentage had decreased to 32%. The latest research suggests that it is projected that R&D activity within the region will dip to 25% by 2030 and further decline to only 21% by 2040 as compared to other regions. In the meantime, it is also expected that China’s contribution will surge significantly from the 2% that was witnessed in 2010 to 17% in 2040.