Dutch drugs association wants clear, predictable reimbursement procedures from pharma package

The Dutch innovative medicines association, VIG, says amendments to the pharmaceutical legislation adopted by the European Parliament aren’t enough to ease concerns.

In April, MEPs adopted their proposals to revamp EU pharmaceutical legislation, which they say will foster innovation and enhance the security of supply, accessibility and affordability of medicines.

The new directive and regulation were adopted by a large majority. The initial reaction of the VIG, which is a member of EFPIA, was that the amendments were a cautious step in the right direction.

“We are still very much concerned, but less so than a year ago,” VIG spokesperson Anton van Tuyl told Euractiv.

While the VIG is happy to see the EP acknowledge the connection between protection periods and investments in R&D resulting in new medicines, it cannot understand why MEPs still want to reduce protection periods, even if only by six months.

“The Commission proposal to reduce the protection period of eight years to six years would have been disastrous,” van Tuyl told Euractiv.

Companies eyeing 7.5 year protection period

MEPs voted for a minimum regulatory data protection period of 7.5 years, during which other companies would not be able to access a drug’s data.

Companies would be eligible for additional periods of data protection if they fulfil certain criteria, such as if their medicine addresses an unmet need or if comparative clinical trials are being conducted on the product. The capped data protection period would be 8.5 years.

According to van Tuyl, it’s still the period of 7.5 years that counts for companies as that’s what they’ll be focusing on when making decisions to go through with the development of medicines – a process van Tuyl highlighted is fraught with high risks and long development times of between 10 to 15 years.

“If you ask if this is adequate enough, I would argue absolutely no. As mentioned before, the status quo is not good, and as an industry, we can only look at the 7.5 years, not any potential additional protection,” van Tuyl said.

Lagging US and China

If things stand as they are, the VIG feels that Europe will still lag behind the US and China in developing new medicines. Even when it comes to getting the newest medicines safely to patients.

“We do not have the most agile and future-proof regulatory framework to assess new kinds of medicines, such as [advanced therapy medicinal products]. Or medicines which can be combined with a diagnostic device or AI,” said van Tuyl.

As for the R&D component, the spokesperson cited a 2023 report from the consulting firm Dolon, which claimed that the “regulatory changes proposed by the Commission would decrease the amount of orphan innovation expected in Europe by 12%, which equates to a ‘loss’ of 45 products between 2020-2035.”

According to Dolon, this could deprive about 1.5 million European rare disease patients of a novel treatment option and the continent of about €4.5 billion in R&D spending.

Pushing for a more risk-oriented approach

The VIG has said it’s convinced it can find workable solutions to improve patient access to medicines by liaising with all the different stakeholders. Asked to elaborate on how the association plans on doing so, van Tuyl highlighted four of the VIG’s solutions that focus mainly on the Netherlands.

These include having a more risk-oriented approach to expensive medicines when it comes to negotiations and more benefit of the doubt to allow new drugs to go faster to patients and making use of real-world data to determine the cost-benefits.

Additionally, the VIG would like to see clear and predictable procedures for reimbursement and European cooperation on Health Technology Assessments (HTA), which will save a lot of time, van Tuyl explained.

“To realise these improvements, you need to cooperate between the relevant ministries and agencies, insurers, companies, scientists, hospitals, doctors, pharmacists and, not in the least, patients,” van Tuyl said.

Van Tuyl also referred to a statement by the VIG’s President, Mark Kramer, dealing with myths the association identified related to drug spending. Kramer said all these different stakeholders must ‘sit down together’, adding that arriving at a more constructive drug policy “requires courage and a willingness to compromise”.

Above all, van Tuyl hopes that member states can bring the pharmaceutical package to a successful conclusion.

“The European Parliament has made improvements to the initial proposal in some areas, but we are far from finished,” van Tuyl said.

[By Christoph Schwaiger, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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