How Gates and the WHO captured regulatory bodies across the globe—all in the name of $$$$$

It's as plain as the nose on your face

[This was first published May 2024]

Begin with an internet search

This post will explain how Gates, the WHO and other ’voluntary’ (self appointed) bodies infiltrated legitimate regulatory bodies with delegated country or region responsibility for drugs and other medicinal products. It begins here:

Type MHRA into a search engine, and the chances are this blog will appear:

Global reflections on international inspection transformation: ICMRA remote inspections

The opening text reads:

A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.

What in heaven’s name is the International Coalition of Medicines Regulatory Authorities (ICMRA)?

It describes itself as so:

International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to:

• address current and emerging human medicine regulatory and safety challenges globally, strategically and in an on- going, transparent, authoritative and institutional manner

• provide direction for areas and activities common to many regulatory authorities' missions

• identify areas for potential synergies

• wherever possible, leverage existing initiatives/enablers and resources

ICMRA will provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues.

The membership is impressive, to say the least. Here are the TERMS OF REFERENCE AND RULES OF PROCEDURE dated 15th November 2023.

The last appendix to the document lists the meeting locations hosted from 2006 onwards (yes, this has been going on for a very long time):

APPENDIX V: RECORD OF HOSTS OF THE SUMMIT (WHICH HAS NOW MERGED WITH THE ICMRA SUMMIT)

Year Authority Location

2006 The U.S. - FDA Washington

2007 Ireland - HPRA Dublin

2008 Singapore- HSA Singapore

2009 Canada - The HPFB of Health Canada Ottawa

2010 The UK - MHRA London

2011 Australia - TGA Sydney

2012 Brazil - ANVISA Manaus

2013 The Netherlands - MEB Amsterdam

2014 China - CFDA Beijing

2015 México - Cofepris Mexico City

2016 Switzerland - Swissmedic Interlaken

2017 Japan – MHLW/PMDA Kyoto

2018 The U.S. – FDA Washington

2019 Italy – AIFA Rome

2020 ICMRA Secretariat (EMA) Remote

2021 Brazil – ANVISA Remote

2022 Ireland – HPRA Dublin

ICMRA Chair

The Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) is Ms Emer Cooke.

Emer Cooke began her mandate as ICMRA Chair on 16 November 2020.

She has over 30 years of experience in international regulatory affairs, with more than 18 of these in leadership roles. Before taking up her current role, she was the Director responsible for all medical product-related regulatory activities at the World Health Organization (WHO) in Geneva between November 2016 and November 2020.

Ms Cooke worked at EMA between 2002 and 2016, holding various positions including Head of Inspections and Head of International Affairs. Prior to that, she was Principal Administrator in the Pharmaceuticals Unit of the European Commission between 1998 and 2002, with responsibility for inspections, international activities and legislative initiatives.

Previous ICMRA Chairs

• Guido Rasi, Executive Director of the European Medicines Agency (EMA) (2019 - 2020)

• Dr Ian Hudson, Chief Executive of the UK Medicines and Healthcare Products Regulatory Authority (MHRA) (2016 - 2019) [from 2019 onwards, Senior Advisor, Integrated Development, Bill & Melinda Gates Foundation. Note from Hedley - Hudson is now retired, apparently]

Returning to the Blog and reflection paper

The Blog continues:

In August 2020, under the Chairmanship of Paula Walker, MHRA GCP Inspectorate Operations Manager and a Senior GCP inspector, the International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group to look at the move to remote inspections for GCP and GMP during the pandemic. 

[Question: Why would they be investigating remote inspections, they are useless?]

On behalf of MHRA, Walker comments:

I was fortunate to chair this group of highly experienced regulators, reporting in to the ICMRA COVID-19 working group.

The working group…included representatives from US-FDA, EMA, Health Canada, Swiss-medic, HPRA Ireland, AEMPS Spain, ANSM France, PEI Germany, MHLW/PMDA Japan, TGA Australia, ANVISA Brazil, HSA Singapore, WHO, Saudi-FDA. 

After an initial deep dive presented to the ICMRA Policy group in October 2020 on initial experiences of the changes to regulatory oversight to remote ways of working driven by the pandemic, the group moved forward to start work on a reflection paper on GCP and GMP remote inspections during the pandemic.

Walker comments further:

I am pleased to say that the ICMRA paper has now been published here .  The paper is a collective reflection on the type of remote approaches taken by the different regulators across the globe.

Details of the paper can be found in the link above. For the time-poor among us, this is a conclusion taken from the opening section:

While the ICMRA group have found remote inspections an enabling tool to maintain at least a minimal regulatory oversight during the pandemic, it is not the view of the group that remote inspections would fully replace an on-site inspection programme. Notable limitations, with current available technological means, have been identified during the experience with the use of remote assessment of regulatory compliance and are described in the relevant subsections.

What have we learnt here, and why should we be concerned?

In no particular order, this tells us:

1. MHRA is at the centre of forming and enabling a self-appointed organisation known as the International Coalition of Medicines Regulatory Authorities (ICMRA). In doing that, MHRA is undermining the role and authority of country appointed competent authorities responsible for drug licensing, inspections etc.

2. Current and former leadership of ICMRA have held executive positions at the World Health Organisation, MHRA, European Medicines Agency, and the Bill & Melinda Gates Foundation. Clear conflicts of interest here.

3. The reflection paper states (albeit low key) that remote inspections are not sufficient to replace on-site inspections, and it only refers to GMP and GCP inspections, no reference to GLP, GDP or Pharmacovigilance. When will on-site inspections resume?

The three points above don’t even begin to express the dangers of this conflicted approach we are seeing unfold. You will have your own searching questions I’m sure.

One final MHRA leadership conundrum

Take a look at the MHRA Executive Committee, towards the bottom of the link:

The Executive Committee is the highest executive decision-making body of the Agency and is chaired by the Chief Executive Dr June Raine. Executive Committee ensure that the decisions which are critical to the Agency are taken in a timely way, at the right level in the organisation, by the right people with the right evidence. This ensures clear accountability for delivery, strong management of risk, transparent priorities and that business is conducted in a smooth and predictable fashion. It is comprised of;

• Dame June Raine DBE (Chief Executive)

• Claire Harrison (Chief Technology Officer)

• Laura Squire (Chief Healthcare Quality and Access Officer)

• Marc Bailey (Chief Scientific Officer)

• Alison Cave (Chief Safety Officer)

• Glenn Wells (Chief Partnerships Officer)

Check their extensive biographies (here’s a sample: Chief Technology Officer - The Chief Technology Officer leads the work of the agency in using technology to help us deliver the best for patients).

That’s it for now,

Hedley