Source: elmundo.es
Innovation in the European pharmaceutical industry is ‘at stake’ in the new European legislation. In the midst of the regulatory reform process, which is necessary because it has not been updated for 20 years, there are details such as the reduction of incentives and its impact on competitiveness with markets such as the United States or Asia that cloud a possible advance in the regulation of the approval of new 21st century therapies that require updated codes.
Spain plays a leading role with the Spanish Presidency of the Council of the European Union. José Manuel Miñones, Minister of Health of the Spanish Government, has announced that one of the key issues on the table at the meeting of EU presidents in October will be the Open Strategic Autonomy (OSA) project and its impact on industry. “This was discussed at the informal meeting of health ministers last July in the Canary Islands”.
This initiative seeks to ensure the EU’s strategic autonomy in key sectors such as energy and health, through recommendations on issues such as the availability and production of active pharmaceutical ingredients (APIS). The Spanish Presidency is finalising the draft to be presented in October, which will seek an agreement to ensure that the supply chains of medicines are diversified and secure so that Europe can meet its needs, explained the acting Minister of Health.
This announcement was made at the annual meeting of the Spanish pharmaceutical industry, which is currently being held in Santander by Farmaindustria, the employers’ association for laboratories. In his speech, Miñones also made it clear that the Strategic Plan for the Pharmaceutical Industry, which he presented to the government last December, will be implemented. “We are going to create a favourable environment,” the minister remarked.
Spain has a lot at stake: an investment of 8,000 million, 4,500 young jobs and 48,000 million in exports over the next three years. So it cannot afford to miss this opportunity. And that is why he has not hesitated to describe industry as “a fundamental ally if we want to continue moving forward”.
Farmaindustria, through the intervention of its director general, has taken up the gauntlet. Juan Yermo stated the need for “appropriate government policies, good governance, effective public-private collaboration and sustainable investment in healthcare”.
Yermo recalled the axes on which this roadmap pivots. “The three main priorities have not changed. Improving access to medicines for patients, boosting R&D to consolidate the biomedical innovation ecosystem, and strengthening industrial capacities and creating resilient medicine supply chains”.
For this reason, Miñones said they will develop “legislative measures to get the medicine to the patient. We will combine this with keeping older medicines on the market, which will be those on the published list of strategic medicines.
Natalie Moll, director general of the European Federation of Pharmaceutical Industries Associations (EFPIA), also pointed out in her speech at the conference that “the loss of incentives to provide the necessary access to medicines is an obstacle to return on investment”.
And as key examples of why this is essential, Yermo put concrete figures on the table. “More than 70% of the increase in life expectancy between 2000 and 2009 in Western countries is due to the use of innovative medicines. And in Spain, “according to the latest study by Professor Lichtenberg of Columbia University, cancer drugs reduce cancer deaths by almost 30% each year. And, for example, in cardiovascular diseases, the reduction in mortality thanks to medicines is 50%.
In the afternoon session, César Hernández, director general of the Common Portfolio of Services of the National Health System and Pharmacy of the Ministry of Health, focused on the necessary balance between incentives, access and pharmaceutical sustainability. “The problem is how to put in a box: the benefits, for a number of patients and each with a price”.
“All this is complex and has not been solved anywhere in the world,” he stressed, while insisting that “we have to look for the best solution that suits our needs”. Hernández also acknowledged that while it takes a long time to access new therapies, Spain is a leader in clinical trials and “a large number of patients benefit from them”.