In this episode of Covington’s Life Sciences Audiocast, Marie Doyle-Rossi, Anna Wawrzyniak, and Valeria Sturla discuss the position adopted by the European Parliament on 10 April 2024 on the Commission proposal to reform the core EU pharmaceutical legislation.

Parliament’s position comes less than a year since the Commission published its proposal, and constitutes a significant step in the legislative process. Although many of the Parliament’s amendments to the Commission proposal can be seen as improvements by the innovative industry, many challenges and some unresolved questions remain, especially in relation to the incentive regime.

During this audiocast, we therefore discuss improvements, challenges and unresolved questions of the EU Pharma law review, with a particular focus on incentives.

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Photo of Marie Doyle-Rossi Marie Doyle-Rossi

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics…

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics, biologics, combination products, digital health and personalized medicine.

Marie provides strategic, policy and regulatory advice on biologics, orphans, human tissue and cells, market and data exclusivity, clinical trials, pricing and reimbursement, product life-cycle management, data privacy and compliance issues.

She has developed considerable expertise in GxP, including adverse event reporting, quality systems and manufacturing, supply chains and recalls. She regularly counsels clients on “Brexit” related issues from both a UK, EU and Irish perspective.

Marie also advises on, and performs regulatory due diligence for, corporate/commercial transactions including acquisitions, public offerings and clinical trial agreements.

She is associate co-chair of Covington’s Food, Drug, and Device Rapid Response team during the COVID-19 pandemic.

Photo of Anna Wawrzyniak Anna Wawrzyniak

Anna Wawrzyniak is a senior scientific and regulatory advisor in the Life Sciences team. As a non-lawyer with a Ph.D. in biomedical sciences, Anna provides detailed scientific and regulatory advice to the firm’s pharmaceutical, food and feed clients. She draws on her technical…

Anna Wawrzyniak is a senior scientific and regulatory advisor in the Life Sciences team. As a non-lawyer with a Ph.D. in biomedical sciences, Anna provides detailed scientific and regulatory advice to the firm’s pharmaceutical, food and feed clients. She draws on her technical and regulatory expertise to help clients in strategic planning and in navigating regulatory proceedings, especially in areas where a deep understanding of the underlying science is important. In particular, she advises pharmaceutical clients on regulatory issues relating to product classification, biologics, advanced therapies, orphans, paediatrics, market and data exclusivities.

Anna has deep expertise in the following areas:

  • The development and approval of medicinal products;
  • Strategies for obtaining and maintaining regulatory exclusivities, including orphan market exclusivities, regulatory data exclusivities (new active substance status) and paediatric incentives;
  • Support to high stake litigation on regulatory aspects;
  • PRIME, accelerated approvals, conditional and exceptional marketing authorisations;
  • Advanced therapies, biologic and substances of human origin;
  • Borderline classification;
  • Regulatory due diligence;
  • Novel foods and food supplements; and
  • Feed.
Photo of Valeria Sturla Valeria Sturla

Valeria Sturla is an associate in the Life Sciences team. She advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, and her practice focuses on EU, French and Belgian regulatory advice. Valeria has also…

Valeria Sturla is an associate in the Life Sciences team. She advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, and her practice focuses on EU, French and Belgian regulatory advice. Valeria has also assisted in several litigations before the Court of Justice of the European Union, including as part of pro bono efforts. She is a native Italian speaker and fluent in English and French.