“The situation is not satisfactory”

One of the more important aims of the EU pharmaceutical legislation is to ensure access to affordable medicines to all patients in the region. A new product, for example to treat cancer, should be available for all EU patients, including those in the smaller member states. The reality, however, is that many of the new products are not available in all countries.

In Germany, 147 out of 168 medicines approved by EMA between 2018 and 2021 were available, while in Malta the corresponding number was 10 medicines. Obviously, the situation is not satisfactory, hence in the draft pharma legislation released this spring, the EU commission is taking measures towards more equitable access within EU.

In Germany, 147 out of 168 medicines approved by EMA between 2018 and 2021 were available, while in Malta the corresponding number was 10 medicines.

One downside for pharma companies in the legislation proposal is the reduction of the period of regulatory data exclusivity for innovative medicines from eight years under the existing legislation down to six years. The upside is that pharma companies will benefit from an additional two-year period of data exclusivity if they market the medicinal products in all Member States within two years from the date of authorization. And in sufficient quantities necessary to cover the needs, no cheating. According to the EU Commission, this additional regulatory protection of 2 years if medicines are launched in all Member States is expected to increase access by 15%. Currently, the requirement is to put the new product on the market in at least one EU country within 3 years, the “Sunset Clause”, which is of course less of a burden for the companies.

There is a risk that seeking EU-approval of new products will be down-prioritized because of the shortening of the exclusivity period and then nothing will be gained by the updated regulation.

Now, the idea to incentivize companies to reach more patients is understandable. The legislative tool-box is limited, but carrots in the form of longer exclusivity has already proven successful, this has for example increased registration of new products in rare diseases. But will it also work to increase access for all EU patients? Not surprisingly, EFPIA is skeptical. There is a risk that seeking EU-approval of new products will be down-prioritized because of the shortening of the exclusivity period and then nothing will be gained by the updated regulation. Many of the delays to the market are occurring awaiting national decisions on pricing and reimbursement. To close the gap between Germany and Malta all stakeholders in the process from approval to patient access must take action. Also including the pharma industry.

Marie Gårdmark, CEO RegSmart Life Sciences

Column written for Life Science Sweden, September 2023

Photo: Volodomyr Hryshenko, Unsplash