Drugmakers pledge faster market launch in Europe to avoid strict laws

To avoid tougher regulations introduced by Brussels, several drugmakers have reportedly agreed to speed up the market debut of new treatments in underserved European Union member states.

In a statement, the EFPIA (European Federation of Pharmaceutical Industries and Associations) stated that its members have vowed to file for compensation by national health systems two years after EU regulatory approval, assuming local systems would approve the same.

While medicine approval in the EU is mainly centralized, with the European Medicines Agency functioning as a regulator, procedures for determining treatment prices for national health systems stay with the member states and vary widely.

According to EFPIA, the plan would cut the time patients wait for new medications by four to five months in certain countries, including Poland, Bulgaria, and Romania.

But an advocacy group has claimed that any new restrictions requiring drugmakers to deliver new drugs to all EU countries within a particular time frame might backfire, further discouraging other businesses from introducing some products to public health systems in the EU.

EFPIA has also stated that some of the proposals could create obligations for drugmakers in terms of market supply to all EU Member States.

Meanwhile, the pharmaceutical industry is found to be concerned about the usage of regulatory tools established for medicines approval being employed to solve availability issues that are within member states' purview, the EFPIA added.

According to a report, the average time between EU market clearance and specific patient groups obtaining a newly produced treatment varies greatly across the EU, ranging from 133 days in Germany and 497 days in France to 899 days in Romania.

It appears that these delays were caused by various regulatory constraints outside the companies' control. The lobbying group also said that it would propose a harmonized system of tiered medicine pricing depending on a country's ability to pay in the EU's very fragmented price-setting landscape.

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https://www.theedgemarkets.com/article/drugmakers-pledge-speedier-european-market-launches-avert-stricter-regulation