Legal and Regulatory Challenges Related to Patient-Centricity in Drug Development: How Far Can Companies Go?

As ‘patient centricity’ penetrates the life sciences sector, the pharmaceutical industry is becoming increasingly interested in involving patients during the development of new drugs. Companies explore new ways to understand patients’ needs and attempt to take those needs into account when designing clinical trials, defining trial recruitment programs, drafting protocols and informed consent forms. In parallel, initiatives by the EMA and national payers (including NHS England) to incorporate patients’ views in risk-benefit and cost-efficiency evaluations, as well as companies’ attempts to improve their reputation in the patient community, provide additional incentives for the industry to listen to patients’ voice. Pharmaceutical companies thus establish collaborations with patient associations, engage directly with individual patients, and take advantage of connected technology and social media to gather patient information. The new Clinical Trials Regulation will also play a fundamental role by increasing the flow of patient data that companies will have access to in the near future.

But how far can pharmaceutical companies go? What are the limits set by law and regulation? Pharmaceutical regulation differentiates medicinal products from ordinary consumer products, and distinguishes patients from consumers. As the industry takes a distance from their traditional drug development model and embraces a patient-centric approach, it inevitably encounters a number of legal and regulatory challenges: how should companies behave when they interact with patients and patient associations? What are the limits to direct patient interaction? Can a company advertise a clinical trial? Can a company host an online blog on a specific disease? What liabilities attach in case a company comes across adverse event reporting in social media?

This session will explore the legal and regulatory issues that the pharmaceutical industry is likely to encounter as it goes ‘patient centric’. It will explore the framework that applies to the interactions between the pharmaceutical industry and patients, both individually and through patient associations. It will specifically cover aspects such as the regulatory requirements that apply to collaborations between the industry and the patient community, the direct promotion of medicinal products and clinical trials, the involvement of patients through social media, blogs, and mobile apps, and the use of patients’ input in the development of new treatments.

About the speaker
Marco de Morpurgo

Marco de Morpurgo is an associate in the Paris office of Allen & Overy. He practises regulatory law in the life sciences sector. He has substantial expertise under EU, UK, Italian and Spanish law and focuses on multi-jurisdictional advisory work. He holds an LL.M. from Harvard Law School and a Ph.D. from the University of Milan. He is qualified in Italy, Spain and New York.

Steven Rix

Steven Rix is the Senior Professional Support Lawyer for the global life sciences sector group at Allen & Overy. He joined from GlaxoSmithKline where he was Assistant General Counsel. He spent 16 years with the company, providing regulatory counsel across the pharma, vaccines, and consumer healthcare businesses, particularly the registration, manufacture, distribution, advertising, and promotion of medical products in Europe and the emerging markets.

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