The Dutch revolutionary medicines affiliation, VIG, has urged the Dutch authorities to alter its place on the revision of the EU’s pharmaceutical laws, claiming the present plans can have disastrous penalties for the nation.
The parliamentary group of the far-right coalition accomplice PVV requested the federal government if there can be simply as a lot, or extra, drug improvement within the Netherlands if the regulatory knowledge safety (RDP) interval for brand new medicines was shortened from eight to 6 years.
In late March, the federal government responded to the parliamentary query, saying it couldn’t supply such a assure.
The federal government additionally confirmed its help for the proposed revision. This follows Dutch Well being Minister Fleur Agema’s latest endorsement of the proposed Crucial Medicines Act (CMA), which goals to enhance the supply of vital medicines within the EU.
“The Fee’s plans make Europe extra depending on the US and China,” VIG stated in its pressing letter despatched to the Home of Representatives, including that this may immediately have an effect on the incomes capability of the Netherlands.
Geopolitical uncertainties and dated framework
In line with VIG, a member of EFPIA, the federal government’s stance will result in fewer new medicines for Dutch sufferers, whereas the nation’s revolutionary energy will take successful.
VIG pointed to present geopolitical tensions, including that financial safety, resilience, and autonomy have gotten more and more vital. Adopting the European proposals as they’re now can be “irresponsible”.
The organisation acknowledged that present guidelines wanted to be up to date since they’re greater than 20 years previous, stressing that trendy pharmaceutical laws is “urgently wanted”.
Nevertheless, it referred to as out the federal government for persevering with to concentrate on a 25% discount of regulatory knowledge safety (RDP), a restricted interval of exclusivity for a corporation’s innovation.
Forging forward would imply the Netherlands would lose roughly €70 million per 12 months in R&D investments, equal to 10% of the entire investments in Dutch drug improvement, they famous, including that over the subsequent decade, 50 fewer medicines can be developed than initially anticipated.
They highlighted that crucial negotiations on the legislative bundle will happen by the top of Might, urging the Dutch authorities to rethink its negotiating place in Brussels, and doubtlessly mannequin it nearer to that of Belgium and Germany “to face for the upkeep of the present safety intervals.”
“However, the Netherlands has supported [the Commission’s] plans unchanged for 2 years, though the world has modified dramatically since then,” a VIG spokesperson stated.
[Edited by Vasiliki Angouridi, Brian Maguire]
