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Orphan drugs

EMA hosts meeting to speed up patient access to new drugs

Easier access to medicines for EU citizens has taken a step forward after a first meeting of the European Medicines Agency (EMA) and European Union healthcare payers.

The meeting held on 19 September 2017 was the first step in a bid to streamline drug authorisation decisions across Europe.

The EMA said it hoped collaboration between regulators and healthcare payers, including insurers and health mutual, would help to improve and speed up patients’ access to new treatments, particularly in the challenging field of medicines for rare diseases — orphan medicines.

EMA met representative bodies including the Association Internationale de la Mutualité, the European Social Insurance Platform, the Medicine Evaluation Committee, and the Mechanism of Coordinated Access to Orphan Medicinal Products, a group campaigning for access to products for rare diseases.

Patient access to new medicines in the EU currently begins with marketing authorisation, which is granted following the assessment of the benefits and risks of a medicine by a regulatory authority such as the EMA. Pricing and reimbursement decisions are then adopted by healthcare payers at a national and regional level.

But the EMA said delays can occur in negotiations because drug developer companies focus on the safety, efficacy and quality of a medicine without always providing sufficient evidence around pricing and cost-effectiveness. As a result, more research is needed post-authorisation before a drug can be released to market, thereby slowing down the introduction of new medicines.

EMA executive director Guido Rasi said regulators and payers had an increasingly important role as enablers of medicine development.

“Our co-operation can help medicine developers to address some of the inefficiencies of the current system of clinical research, so that they become better at generating the evidence each of us needs for good decision-making,” he said.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203653

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