Debates across Europe are needed to ensure that other global markets do not overtake it following the infamous EU Pharmaceutical Legislation, says Ricardo Marek, president of the Europe and Canada business unit at Takeda.
Speaking at the opening day of the FT Global Pharma and Biotech Summit in London, Marek noted how the reformed legislation, which was released by the European Commission (EC) in April, will establish the next few decades of the European market.
While the new legislation shifts focus to garnering equal access to new medicines across the EU, certain policies may stifle innovation in the region. For example, there will be a shorter regulatory data protection period, meaning generic drug makers will not be able to refer to innovator drug’s data to obtain marketing authorisation. Also, approved drugs must be launched in all EU countries within two years.
In the panel “Macro Focus – How is Pharma Responding to Major Reforms and Global Disruption?”, Marek notes that the industry needs to make sure that these incentives are strengths and not weaknesses.
Samantha Pearce, senior vice president of Europe and International at Jazz Pharmaceuticals, says that reforms and legislative shifts can be extremely powerful. However, it is important to ensure that they do not have any unintended consequences that could inhibit the amount of investment.
On 6 October, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report on the impact of EU pharma legislation. The organisation indicated that Europe’s share of global R&D investment is estimated to drop a third by 2040. This equates to €2bn ($2.1bn) in lost R&D investment each year.
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EFPIA has also reported that the R&D investment gap between the US and the EU has increased by over €20bn ($21.4bn) from 2002 and 2022. While Europe lags behind, R&D spending in China was three times higher than in the EU between 2018 and 2022.
Indeed, China is asserting itself as one of the more attractive markets to launch products. Julia Hoover, general manager of UK and Ireland at Ferring Pharmaceuticals, says there is a shift in the major markets. While the US remains at the top of the list, Asian and South American countries are sometimes coming ahead of Europe.