WIREDGOV

The first steps have been taken towards new market authorisation and reimbursement procedures for innovative medicines. Over 100 experts from across Europe discussed the topic in Amsterdam at the invitation of the Minister of Health, Welfare and Sport, Edith Schippers.

Increasing availability of innovative medicines

More and more innovative medicines are becoming available. This is good news for the patients who need them. However, since these medicines are often intended for a small group of people, there is not always enough research data available. This means it takes longer to determine the efficacy, safety and added value of these drugs. And the longer that takes, the longer patients have to wait until they can obtain the new drugs.

Accelerating market authorisation

During the Dutch EU Presidency, Ms Schippers would like to speed up market authorisation procedures for new medicines. ‘Here in Europe we need to look at how we can get these medicines to patients who’ve been waiting for them as soon as possible, without any safety risks,’ said the minister. ‘This must go hand in hand with affordability. After all, what’s the point of authorising a medicine if it’s completely unaffordable? Innovative medicines require effective collaboration on market authorisation and reimbursement policies at an early stage. At present, there is insufficient cooperation between the authorities responsible for these at both national and international level.’

Three key questions

The experts looked at the various methods for accelerated or conditional market authorisation and ways for different countries and authorities to share research data with each other. They examined three questions. What products need to be made available more quickly? What conditions should we place on this? And what procedures need to be better aligned?

Broad agreement on urgency

The discussions revealed that the experts agree on the importance of taking joint action. A future-proof EU system will require both an updated market authorisation policy and new reimbursement methods. More effective collaboration between the authorities responsible for market authorisation and reimbursement is crucial to fast, affordable access to innovative medicines.

Results

The findings of the conference will be addressed at the health council meeting in April, when health ministers from the 28 EU member states will discuss the EU’s policy on medicines.