Regulatory simulations at home and abroad: Mutual Recognition AgreementsFirst in series on legal links connecting domestic and international non-regulation of non-medicines.
American Domestic Bioterrorism Program Related Bailiwick reporting and analysis
Introduction Sasha Latypova and I have documented how American pharmaceutical companies have contracted with the US Department of Defense, Department of Health and Human Services and many other federal agencies, divisions and officials, under authorities granted by Congress and US presidents through the 1938 Food Drug and Cosmetics Act, 1944 Public Health Service Act, 1950 Defense Production Act and related statutes, implementing regulations and executive orders, to intentionally, with complete legal impunity, poison recipients of vaccines and other drugs and biological products since January 2020, through the deployment of non-regulated, intentionally toxic medical countermeasures (MCM) under public health emergency (PHE) legal conditions. Recently, I've been looking at international Mutual Recognition Agreements, and how they fit into the global legal system that enables poisons-labeled-as-medicines to enter interstate commerce in the US, and also enter international trade, unimpeded by American drug safety regulations and also unimpeded by regulatory systems in other countries. Mutual Recognition Agreements are mechanisms through which regulatory agencies in one country can legally rely on the claimed validity of another country's regulatory reviews and decisions, to authorize import and use of the allegedly regulated product in the importing country. International MRAs were put into place in the 1990s, and should be understood as working together with the gutting of US biological product regulation under non-emergency conditions, which predates Covid. So far, I've identified at least four examples of such rule changes promulgated by FDA officials since 1973 that I hope to describe in future installments of this series. One of those is the elimination of scheduled FDA inspections of biological product factories and inspector duties, effective May 2, 2019. MRAs and the gutting of US-FDA biological product regulation should also be understood as working together with the Public Health Emergency-Emergency Use Authorization-Medical Countermeasures system, which guts regulatory functions under emergency conditions. These are examples of redundancies built into kill box laws, layer upon layer, allowing the killers to assure themselves that they will be able to legally continue to kill even if some of the enabling laws and regulations were to be acknowledged and repealed or nullified by Congress, American state governors and lawmakers, and/or state and federal judges. The takeaway message is this: Stop taking vaccines. Every layer of kill box law identified, supports the actionable conclusion that governments are intentionally sterilizing and killing off their populations, and that vaccines and other biological products are the class of weapons they prefer to use. The killers prefer biological weapons packaged as medicines because it's very difficult for targets to see needles, nasal sprays and skin patches as weapons. It's very difficult for targets to see pharmacists, nurses and doctors as armed military contractors. It's very difficult for targets to see neighborhood retail pharmacies and doctors' offices as killing floors. Memoranda of Understanding and Confidentiality Commitments During a recent interview, the topic of Memoranda of Understanding or MOUs between the US Food and Drug Administration (FDA) and drug regulators in other countries, came up. The MOUs I have on file are mostly internal to the United States. They are contracts between different agencies to share information about "medical countermeasures" development, regulation and production among themselves and keep the information out of public view.
I also have some confidentiality agreements between the US-FDA and other countries, contracting to share information about drug, device and biological product regulation among themselves and keep the information from the public.
While looking at the domestic drug regulation MOUs and international drug regulation confidentiality agreements, I found another form of international contract: Mutual Recognition Agreements. Mutual Recognition Agreements Mutual Recognition Agreements or MRAs are international treaties or trade agreements governing the import and export of regulated, manufactured consumer products. MRAs have been negotiated and signed to enable regulators representing different countries to share information about their regulatory reviews, keep the regulatory information confidential from the public, and defer to each others' legal decisions concerning regulatory compliance, without conducting independent evidentiary collection and assessments. Political and economic momentum for MRAs developed in the mid-1980s, exemplified by a May 7, 1985 European Council resolution "on a new approach to technical harmonization and standards," followed by EC Resolution 90/C 10/01, "on a global approach to conformity assessment" adopted Dec. 21, 1989, accompanied by the founding of the International Committee for Harmonisation in 1990. The US-European Union Mutual Recognition Agreement was negotiated in 1997 and 1998, signed in London on May 18, 1998, and entered into force Dec. 1, 1998.
The MRA covers several manufacturing sectors, including telecommunication equipment, electromagnetic compatibility, electrical safety, recreational craft, pharmaceutical Good Manufacturing Practices (GMPs) and medical devices. US-FDA inserted the 1998 MRA sectoral annex provisions on pharmaceutical GMPs into the US Code of Federal Regulations at 21 CFR 26, by Federal Register Notice of Final Rule.
US and EU officials negotiated an "amended sectoral annex for pharmaceutical good manufacturing practices," signed in 2017, which entered into full force July 11, 2019 after a transition period. Among other provisions relevant to the non-regulation of the non-medicines known as Covid-19 vaccines, Article 9 of the 2017 sectoral annex for GMP "relieved" the "qualified persons" in EU countries who receive drug products imported from the United States of "responsibility for carrying out" batch testing controls, under Article 51, Paragraph 2 of EU Directive 2001/83/EC, Community code relating to medicinal products for human use, as adopted by European Parliament and European Council Nov. 6, 2001. The US-FDA currently has signed, in-force MRAs covering pharmaceuticals intended for human use with at least 29 countries in Europe. Effective May 30, 2023, more than half of the participating countries expanded the scope of the Mutual Recognition Agreements to also include animal (veterinary) drugs. Biological products for poisoning livestock are being rapidly developed and deployed on ranches and farms in the US and worldwide. Sasha Latypova reporting:
Most European countries were folded into the US-EU MRA treaty through the European Union, with each country's government recognizing the treaty and the amended sectoral annex between November 2017 and November 2019. Nov. 1, 2017
March 1, 2018
June 1, 2018
Sept. 14, 2018
Nov. 16, 2018
Feb. 7, 2019
April 29, 2019
June 10, 2019
June 26, 2019
July 11, 2019
Nov. 28, 2019
Although Switzerland and United Kingdom are not member-states of the European Union, both are also parties to MRAs with the United States, effective Nov. 1, 2017 for the UK Medicines and Healthcare products Regulatory Agency (MHRA), and July 27, 2023 for the Swiss Agency for Therapeutic Products (Swissmedic).
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