IML Warns of EU Pharmaceutical Legislation Reform's Threat to Medicine Access

Innovative Medicines for Luxembourg (IML), has warned of the dangers of the reform of European pharmaceutical legislation.

Deleterious effects on the competitiveness of the Europe zone, and by extension in Luxembourg, are to be expected on the importation, distribution and availability of medicines, IML noted.

The latest study by the European Federation of Pharmaceutical Industries and Associations (EFPIA), in association with the consulting firm Dolon, published on 6 November 2023, showed that several European countries will be affected by the reform, including Germany, France and Belgium. The three countries bordering Luxembourg maintain close relations with the Grand Duchy in terms of imports.

In 2010, Europe represented 37% of global R&D investments; in 2020, this figure fell to 32%. According to a new study and with this reform, this figure should further decrease by 2030, to reach 25%, and by 2040, to only represent 21% of R&D activities compared to other regions of the world. At the same time, China's contribution is expected to increase from 2% in 2010 to 17% in 2040.

Luxembourg has no or very few factories for the production of innovative medicines on site. Its cooperation with producing border markets is necessary, historical and functional, since Luxembourg imports 70 to 85% of medicines from Belgium for an amount of approximately $467 million, and around 9.5% of medicines from Germany ($55.4 million).

In Europe, the negative impact of the reform will be general. Germany is expected to be the hardest hit, with a loss of R&D investments of around €626 million per year. For Belgium, where the pharmaceutical industry is very present, this would mean, according to this study, a potential loss of €381 million in investments in R&D. This is a reduction in economic activity associated with these R&D investments, not only for biopharmaceutical companies, but also for the entire healthcare ecosystem, and even beyond, IML noted.

The reform will lead to a reduction in the number of clinical trials, which will have an impact on both hospitals and patients, who will therefore have less access to innovative medicines in the research phase. As EFPIA stated: “It matters where innovation happens”. 

Sonia Franck, Secretary General of IML, said: “Research and development will continue, but the question is where.”

If the reform of European pharmaceutical legislation has a negative impact on the competitiveness of the biopharmaceutical industry in Europe, the three countries most affected are, as a reminder, three border countries which mainly export medicines to Luxembourg.

IML asked the future Luxembourg government, whose parties have included rapid access to medicines for all citizens, to pay attention to the impact of the changes in this reform on the competitiveness of Europe and subsequently, on its repercussions for the Luxembourg.