Drugmakers pledge faster, more equitable medicine access in Europe

Drugmakers have agreed to speed up the market launch of new drugs in underserved EU member states as an alternative to stricter regulation. 

From today, EFPIA member companies commit to file for pricing and reimbursement in all EU countries as soon as possible and no later than two years from the central EU market authorisation, provided that local systems allow it. 

The lobby group says this will increase the availability of innovative medicines in Europe and decrease the amount of time patients spend waiting for new drugs by several months. 

According to data published by EFPIA last week, the gap in the time it takes for patients to access new medicines in different EU member states is widening, with patients in Germany waiting 133 days on average compared to 899 days for patients in Romania.  

There are also disparities in terms of availability of innovative medicines, with less than 30% of centrally approved products available in smaller and Eastern European member states, compared with 92% in Germany and 46% on average in the EU.  

IQVIA modelling predicts that the commitment to file would increase the availability of medicines from 18% up to 64% in several countries. It also estimates a reduction in the time spent waiting for new medicines by up to five months in countries such as Bulgaria, Poland and Romania.  

The commitment to file comes after EFPIA warned against proposed rules that would force drugmakers to bring products to all EU countries within a certain deadline. They say that regulation could backfire and discourage companies from bringing some products to the region’s public health systems altogether. 

The group said: ‘We understand that some of the proposals being discussed could introduce obligations for (drugmaker) to market or supply all EU Member States.  

The industry has concerns regarding the use of regulatory tools designed for medicines authorisation being applied to address availability issues that are within the remit of member states’.  

In addition to the commitment to file, EFPIA said it was proposing an equity-based tiered pricing system, where the price of innovative medicines would vary depending on the country’s ability to pay.