FRANKFURT (Reuters), Monday, drugmakers pledged to expedite the release of new drugs into underserved EU states to avoid tighter regulation from Brussels.

European Federation of Pharmaceutical Industries and Associations, (EFPIA), stated Monday in a statement that their members will file reimbursement requests by national health system within 2 years of EU regulatory approval. This is “provided local systems allow”.

While EU drug approvals are largely centralised through the European Medicines Agency, which acts as a watchdog, national healthcare systems can still be regulated by their own procedures.

The promise would decrease the waiting time for patients to receive new medications by 4-5 months in some countries, such as Romania, Poland, and Bulgaria. EFPIA cited estimates from market researcher IQVIA.

Lobby group warns that new regulations requiring drugmakers in all EU countries to submit new products by a deadline may backfire on companies and discourage them from contributing to local public health systems.

“We are aware that certain of the proposed proposals could create obligations for drugmakers to supply EU member states with drugs,” EFPIA stated in a separate document.

It stated that the industry is concerned about the application of medicines authorisation regulatory tools to remedy availability problems within the scope of the member states.

The report shows that the time it takes for a drug to be approved by the EU and large groups of patients to receive the new product varies widely within the bloc. This ranges from 133 Days in Germany to 497 Days in France and 899 Day in Romania.

EFPIA claimed that delay was caused by regulatory factors which were beyond the companies’ control.

The lobby group also said it was proposing a harmonised system of tiered drug pricing, based on a country’s ability to pay, to replace the highly diverse EU price-setting landscape.