by Michael Nevradakis, Ph.D., Childrens Health Defense:
The U.K. is weighing an initiative to rubber stamp drugs already sanctioned abroad, but critics warn the plan undercuts safety standards and signals a move toward the World Health Organization’s “One Health” strategy.
The U.K.’s drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), is weighing a plan that would result in what The BMJ has described as “near automatic sign off” for medicines “already approved by ‘trusted’ regulators in other parts of the world.”
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The proposal is raising concerns among some medical experts.
According to a JD Supra article, these “new international recognitions routes” announced by the MHRA are intended for the quick “approval of medicines that are already authorised in Australia, Canada, the European Union (EU), Japan, Singapore, Switzerland or the United States.” The new “routes” are expected to begin by Jan. 1, 2024.
Medications already licensed in any of these “trusted partner” countries would receive “a fast-track U.K. application process.”
The plan builds on the MHRA’s existing European Commission (EC) Decision Reliance Procedure and also “complements the U.K. national authorisation process and accelerated access route, the Innovative Licensing and Access Pathway (ILAP).”
This procedure was introduced following Brexit to allow the MHRA to “rely” on drug approvals from the European Medicines Agency (EMA). If a drug has received EMA approval or a “positive recommendation,” the MHRA can then proceed with a “lighter touch” assessment and “accelerated decision from the MHRA within 67 days or less.”
In March, the U.K. government awarded the MHRA £10 million ($12 million) in funding “to help bring innovative new medicines and medical technologies to U.K. patients more quickly.”
Describing this new process as a “milestone,” JD Supra claimed it “is intended to result in faster access for U.K. patients to new innovative medicines.”
The Association of the British Pharmaceutical Industry said the process will reduce “the time delay for regulatory approval.”
Regulators want to ‘please Big Pharma’
Medical and vaccines experts who spoke with The Defender, however, expressed concerns over safety risks associated with an expedited approvals process and a reduction in regulatory oversight.
Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of the Children’s Health Defense (CHD) scientific advisory committee, told The Defender, “The process of ‘harmonizing’ laws and standards between countries — beyond just the EU countries — has been ongoing for years.”
However, “By saying that any friendly nation’s drug regulator decision can stand in your country — well, that obviously will turn into a race to the bottom,” she said, implying that there would be continuous increased pressure to hasten drug development and approvals.
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center and co-author of the 1985 book “DPT: A Shot in the Dark,” told The Defender:
“Over the four decades that I have been an informed consent advocate in the U.S., I have watched Congress direct federal agencies to develop public-private business partnerships with pharmaceutical companies.
“This has led to a systematic lowering of the bar requiring companies to demonstrate new vaccines are safe and effective before licensure so they can be rushed to market, recommended for universal use, and often mandated.”
Fisher gave the example of previously “fast-tracked” vaccines that resulted in bad outcomes for public health. She said:
“Licensed in 2006, Merck’s Gardasil was the first “fast-tracked” vaccine to be licensed by the FDA [U.S. Food and Drug Administration] using an accelerated approval process.
“But the mRNA COVID biological was the first to be approved for public use under an Emergency Use Authorization (EUA) after only nine months of study and it has already racked up a record 1.5 million adverse event reports to the Vaccine Adverse Event Reporting System (VAERS) while making billions of dollars in profit for companies.”
VAERS has historically been shown to report only 1% of actual vaccine adverse events.
Nass referred to a June 2022 BMJ article, “From FDA to MHRA: are drug regulators for hire?” that found “industry money permeates the globe’s leading regulators, raising questions about their independence, especially in the wake of a string of drug and device scandals.”
For instance, the FDA, despite being the most highly funded of the six regulatory authorities studied, receives 65% of its funding for drug evaluation from industry “user fees.”
In 1995, the EMA received just 20% of its funding from industry fees. That figure has since grown to 89%.
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