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Position paper - Evaluation and revision of the EU general pharmaceuticals legislation

27 Apr 2021

AmCham EU is committed to the development of a regulatory environment which furthers the capabilities of European healthcare, improving accessibility and ensuring a crisis-resistant medicines regulatory system. We took the opportunity to outline our perspective at the outset of this evaluation and revision process of the general pharmaceutical legislation.

Important aspects which require attention include:

  • Modernise the pharmaceutical regulatory environment in Europe to account for the next generation of medicines and vaccines;
  • Maintain a robust framework of incentives that specifically tackles high unmet need, for example in the fight against antimicrobial resistance;
  • Recognise the complexity of medicinal product development and avoid reduction of incentives coupled with increasing obligations. This will undermine innovation without improving access and does not serve to establish the EU as a leader in biopharmaceutical innovation;
  • Guarantee strong IP protections to entice long-term global investment in European R&D capabilities;
  • Champion novel approaches to clinical trial design and support the ability of European Medicines Agency (EMA) and national authorities to modernise the European Medicines Regulatory Network and increase uptake of cloud-based systems to enable real time information sharing between industry and regulators;
  • Preserve an open, globally calibrated supply-chain for medicines in collaboration with international partners and stakeholders.

You can read our full response now, which is available below.