Spain to lose €93m annually due to new pharma legislation

The pharmaceutical industry has warned: investment in R&D could be lost if new legislation being prepared by the European Commission for the sector is passed. Specifically, the European Association (Efpia) estimates the amount of losses at 2 billion euros annually.

In Spain, this amount will be at least 93 million euros per year until 2035. These are the findings of a report prepared by consultancy Dolon for Efpia. Although Spain will be one of the countries most affected by the reduction in research investment due to the reform of Europe's pharmaceutical legislation (if enacted), Germany will actually be the most affected. According to Dolon's analysis, Germany will lose 626 million euros annually. They are followed by Belgium and France. In these countries, investment in R&D activities will decrease by €381 million and €326 million per year respectively.

• R&D spending on rare diseases will be cut by €4.5 billion due to new European legislation

Italy will also be affected by new pharmaceutical legislation. In this case, the loss in research investment would amount to 123 million euros annually. Spain will take fifth place. They are followed by Sweden, where investments will drop by €88 million a year, and the Netherlands, with a loss of €66 million. Thus, the consultancy predicts that Europe's share of global R&D investment will fall by a third, from 32% to 21% by 2040. This equates to a loss of 2 billion euros annually.

Loss of competitiveness

Data collected in Dolon's analysis shows that the new legislation, as it is proposed, will seriously damage Europe's competitiveness, making it difficult to attract investment, launch new treatments for patients and keep up the pace of development of more ambitious regions in the field, such as the United States, China and Japan. In fact, Europe has already lost ground.

• Europe loses battle with the US in pharmaceutical R&D: develops just 22% of new drugs

New forecasts show this figure will fall further to 25% by 2030. And by 2040, Europe will have only 21% R&D activity compared to other regions. At the same time, China's contribution is expected to grow from 2% in 2010 to 17% in 2040. In the case of the United States, they will become even more leading. In 2010, they accounted for 47% of the world's R&D tasks. This figure will only increase in the next few years, reaching 58%, according to a report by a consulting firm.

Data protection

Another aspect analyzed in the report published by Efpia is the Commission's proposal to reduce data protection. The current draft proposes to reduce the base period of regulatory data protection (PDR) from 8 to 6 years, "an important component of intellectual property, particularly important for advanced and complex therapies," Farmaindustria explains in a statement. This will result in a 55% reduction in the incentive for companies to invest in innovative medicines. Thus, one in five projects (22%) dependent on data protection (PDR) for drug research and development "will no longer be economically viable in Europe", warns the European Pharmaceutical Industry Association. This could lead to the cessation of research and development of about 50 of the 225 expected new treatments on the old continent in the next 15 years.