Who is calling the shots in EU medicines regulation?

It could be team-Gates...

Hedley Rees

Jul 15

Important background information

In a previous update, I commented on how MHRA has relied upon remote inspections of companies developing and manufacturing the mRNA injections, as well as those carrying out clinical trials.

This MHRA Blog, titled Global reflections on international inspection transformation: ICMRA remote inspections, introduces the concept on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA).

Are you wondering, like me, what the ICMRA is, and what role it plays in regulation of medicines and healthcare products? Have you concluded, like me, it has no role to play?

It appears a self-appointed organisation with no legitimacy when it comes to regulation.

Yet, if you look in here, ICMRA Membership Country/Region and Regulatory Authority' s website, nearly every official regulatory body in the world is a full member or associate member!

What’s more, the Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) is Ms Emer Cooke, who was at the World Health Organization in Geneva between November 2016 and November 2020.

On 25 June, 2020, Ms Cooke was announced as Executive Director of the European Medicines Agency (EMA): Emer Cooke takes office as head of EMA.

This announcement also explained that “Emer Cooke also takes over the chairperson position at the International Coalition of Medicines Regulatory Authorities (ICMRA), which is currently led by EMA.”

Did you get that?

Oh, and the previous Chair of ICMRA was Guido Rasi, Executive Director of the European Medicines Agency (EMA) (2019 - 2020), and before him, it was Dr Ian Hudson, Chief Executive of the UK Medicines and Healthcare Products Regulatory Authority (MHRA) (2016 - 2019).

Dr Hudson is now Senior Advisor, Integrated Development, Bill & Melinda Gates Foundation.

Time for a history lesson (ICMRA website)

The proposal to create an ICMRA is an anchored in the recognition that a Heads of Agency (HoA) leadership is needed to address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner. 
 
In May 2012, before the 65th World Health Assembly in Geneva, more than 30 medicines regulatory authorities participated in a seminar promoted by Brazil aimed at stimulating a debate among health officials and the diplomatic community on how to improve cooperation among medicines regulatory authorities. The discussion highlighted the importance of better promoting and coordinating international cooperation among medicines regulatory authorities in order to strengthen dialogue, facilitate the wider exchange of reliable and comparable information, encourage greater leveraging of the resources/work products of other authorities, and promote better informed risk-based allocation of authorities’ resources. These efforts would strengthen the quality, safety and efficacy of medicinal products globally.
 
These discussions were pursued at meetings of senior executives of several medicines regulatory authorities held on the margins of the International Conference of Drug Regulatory Authorities (ICDRA) in October 2012 and in Manaus at the 7th Heads of Medicines Regulatory Agencies Summit in December 2012. As a result, a consensus has emerged on the desirability of developing an ICMRA to address common issues, such as (but not limited to):
 
• Growing complexity in manufacturing and distribution supply chains for medicinal product (multi-faceted and globally integrated);
• Regulator’s ability to ensure the safety, quality and efficacy of medicinal products domestically requires knowledge of and confidence in these supply chains;
• Gaps in global regulatory oversight providing opportunities for the tampering and counterfeiting of medicinal products;
• Growing complexity in medicinal products and their ingredients (e.g. new chemical entities and innovative drugs) generating new scientific and regulatory challenges which call for new regulatory processes;
• Growing number of international regulatory initiatives, lacking integration and strategic oversight;
• Continued pressures to control and reduce regulatory public expenditures; and
• Continued industry and political pressures to harmonise and align regulatory practices and activities.

Well, how did I miss that one!!! Did you know that???

Back to the MHRA Blog

Going back to the MHRA Blog, Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 Pandemic concludes in part:

“It should be noted that some regulatory agencies are currently evaluating whether to utilise remote approaches going forward. While some ICMRA working group members do not currently think it will fit within their regulatory framework, a number of regulators have expressed an interest in supplementing an inspection, or in some cases, replacing the need for an on-site inspection with remote and/or hybrid approaches.”

What a load of codswallop”! What happened to “As a result, a consensus has emerged on the desirability of developing an ICMRA to address common issues, such as (but not limited to):” (see list above).

After nearly 10 years, is that the best they can do? A wishy-washy statement of the obvious…

…more importantly, of course, is the fact that there is no substitute for physical inspections of safety-critical facilities developing and producing medicines, by experienced inspectors. Without them, no patient is safe.

What is the takeaway here?

This is the takeaway. Regulatory authority boundaries have been blurred by a shadow, ‘voluntary’ organisation, operating globally, to the extent that decision making is totally opaque.

What is the relationship between the World Health Organization, executive leadership of the European Medicines Agency, ICMRA, the Bill & Melinda Gates Foundation and MHRA? We need to know who is calling the shots.