Emphasizing the critical need for patient partnerships in medicines and health devices regulation

Описание: Karen Alparce-Villanueva, President, Philippine Alliance of Patient Organizations (PAPO) [Moderator]

Dr Lembit Rägo, Secretary-General, Council for International Organizations of Medical Sciences (CIOMS)

Janis Bernat, Director, Scientific & Regulatory Affairs, International Federation of Pharmaceutical Manufacturers Association (IFPMA)

Dr Maria Mavris, PhD, Public and Stakeholder Engagement Department - Stakeholders and Communication Division, European Medicines Agency (EMA)

Marie Valentin, Technical Officer, Regulatory Convergence and Networks Team, World Health Organization

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For compassionate, humanised, and patient centric healthcare to happen, we must ensure that the entire healthcare value chain delivers services, medicines and health devices that are of high quality, safe and effective. The medicines and health devices regulators can ensure that this happens.

Market authorisation of innovative medicines and health devices must happen at the same pace and time globally to prevent regional inequity which develops if medicines approval is delayed in some countries, while others have advanced. COVID-19 vaccines market authorisations delays revealed to us how this inequity can impact our health and wellbeing.

During the pandemic, the value of regulatory reliance and early and thorough regulatory approval of innovative and repurposed medicines was critical. This required a whole of government, industry, and patient community partnership with their national medicines regulatory authority. The best outcomes were achieved in regions where new agilities were developed and innovative medicines regulatory pathways created.

In Europe, the meaningful engagement of patients within the European Medicines Agency was critical. The lessons learnt, and new structures developed during the emergency must be leveraged now for routine situations to improve patients’ early access to innovative, quality, and safe medicines globally.

The session will explore how regulatory reliance benefit patients and how patient partnerships advance the regulatory process into delivering safe and high-quality diagnostics, vaccines, and treatments to patients as fast as possible.