EU Vows Rules Revamp for Medicines to Boost Supplies, Innovation

European Union regulators pledged a range of actions to increase the supply of medicines on the EU market as the Covid-19 pandemic accentuates concerns about shortages.

The European Commission presented a “pharmaceutical strategy for Europe” that aims to tackle issues including the development of new drugs and the availability of generic ones. One focus is market barriers for certain medicines, with the commission pledging to consider ways to increase competition.

Also on the to-do list: reducing the EU’s dependence on foreign suppliers of some key medicines and ingredients.

With concrete plans including draft legislation due over the coming year, the commission’s blueprint vows a combination of regulatory tightening and relief for drug makers. The European pharmaceutical industry employs around 800,000 people in Europe and spends about 37 billion euros ($44 billion) a year on research.

“Our pharmaceutical sector is strong, but it can deliver more and it can deliver better,” European Health Commissioner Stella Kyriakides said on Wednesday in Brussels. “We need to adapt in order to avoid bottlenecks and regulatory gaps that hamper innovation and new breakthroughs.”

The EU is working to ensure that universal healthcare systems in member countries can face the challenges posed by aging populations, rare diseases and market obstacles to the availability or affordability of some medicines.

While health policy is largely a national-government responsibility in the EU, European institutions and legislation provide a common regulatory framework for what is the world’s second-largest medicines market. Bloc-wide rules exist on, for example, the production of drugs and the conduct of clinical trials.

The Covid-19 pandemic has exposed healthcare vulnerabilities across Europe as countries scrambled for adequate supplies of basic equipment for hospitals, antiviral medications for patients and possible vaccines for the general population. Even the availability of data has been a concern.

The commission, the 27-nation EU’s regulatory arm, said its pharmaceuticals action plan “is a patient-centered strategy that aims to ensure the quality and safety of medicines, while boosting the sector’s global competitiveness.” The planned actions include:

  • Pilot “innovative approaches” to EU development and public procurement of antimicrobials
  • Coordinate development and manufacturing of novel antibiotics
  • Revise existing legislation on medicines for children and rare diseases “to improve the therapeutic landscape and address unmet needs”
  • Create greater “conditionality” of incentives to support broader access for patients
  • Pursue “targeted policies” to increase generic drugs on the market
  • Steer cooperation between national pricing and reimbursement authorities and healthcare payers
  • Create a “European Health Data Space” to enable better healthcare and research
  • Provide “tailored incentives” for innovation
  • Enact in “full” the regulatory framework for clinical trials
  • Streamline approval procedures
  • Strengthen obligations for supply and transparency
  • Initiate a “structured dialog” with drug makers and governments “to identify vulnerabilities in the global supply chain of critical medicines, raw pharmaceutical materials, intermediates and active pharmaceutical substances”
  • Establish an “EU Health Emergency Response Authority”

©2020 Bloomberg L.P.

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