UK drs concerned about Covid vaccines.. Hippocratic Oath
China Covid deaths are low and realistic :: https://www.zeit.de/gesundheit…us-todesfaelle-gesundheit.
Covid only deaths around 5500. Related deaths of very sick persons. about 55'000. In all UK/English papers just the later figure/total is reported. Average age of deaths is 80 years = older than average.
So it is the same picture as of march 2020 Bergamo. Covid is a harmless illness unless you are seriously sick and pretty old.
So its end of the war against the population as here (Switzerland) the case number evaporated to 1200/week... !!
Display MoreChina Covid deaths are low and realistic :: https://www.zeit.de/gesundheit…us-todesfaelle-gesundheit.
Covid only deaths around 5500. Related deaths of very sick persons. about 55'000. In all UK/English papers just the later figure/total is reported. Average age of deaths is 80 years = older than average.
So it is the same picture as of march 2020 Bergamo. Covid is a harmless illness unless you are seriously sick and pretty old.
So its end of the war against the population as here (Switzerland) the case number evaporated to 1200/week... !!
Not sure if that is the real story... Do you trust China's "official" numbers?
Do you trust China's "official" numbers?
I never trust any Chinese numbers. But US number are 1000% cheated from day one. See NYT. 60'000 Cov-19 cases 50'000 going to hospital.... 
Fact is: CoV-19 is a terminator for old very ill folks. CoV-19 does no harm for most people age <65 that are healthy.
The whole episode was a business/investors spin. In Switzerland the government leaked vaccine buying dates and their fellows did buy large amounts of vaccine stocks - even worse in USA/DE. Of course these folks (FM/JF mafia) did coordinate
I would welcome the death sentence/live time prison punishment for all people involved in the vaccine terror regime of the last 2 years.
Since Bergamo we did know that CoV-19 is harmless for most.
Danish Mass Media Opens Up: It’s Time to Discuss COVID-19 Vaccine Injured
Denmark’s Berlingske has blown open the discussion about COVID-19 vaccine injuries. The major newspaper of Denmark—in fact considered the newspaper of record in this Scandinavian nation of 5.8 million—also happens to be considered one of the oldest dailies in the world in circulation since 1749. Journalist Louise Lund-Sorensen’s report will cause ripples throughout Europe and over to North America, as this influential media in the Danish world represents the latest mainstream media to point its journalistic apparatus at the top of COVID-19 vaccine injury.
Elite Danish athlete Anette Friedrichsen was injured by the Pfizer-BioNTech mRNA COVID-19 vaccine. This isn’t a breaking story, however, as her plight was already covered by the world’s largest COVID-19 vaccine injury patient advocacy organization, non-profit U.S.-based React19.
An internationally competitive rower, Ms. Friedrichsen’s world was turned upside down when after receiving the third booster shot of BNT162b2. The doctors concluded she was vaccine injured.
After the administration of that dose, her lymph node swelled, fever, muscles on the same side swollen, which led to severe chest pains ten days later. Thereafter, Annette was admitted to the hospital 13 times with chest pains and difficulty breathing. With tachycardia (the medical term for a heart rate over 100 beats a minute-- many types of irregular heart rhythms (arrhythmias) can cause tachycardia), the chest pain continued along with pain in the left arm and neck and low oxygen. At points, her heart rate shows up to 212.
So, she went from this incredibly healthy, active life to one where it’s difficult to even breathe; a life where her arrhythmia makes it a challenge to do even the most basic daily tasks, reports Louise Lund-Sorensen for Berlingske.
Doctors frankly, don’t know what to do. And how could they? Apex research units like the National Institutes of Health (NIH) have known about these injuries since early on in the pandemic yet have been highly resistant to discussing the matter due to a combination of factors according to React19 founder Brianne Dressen. TrialSite partnered with React19 founded by Ms. Dressen and Dr. Joel Wallskog to support COVID-19 vaccine injured people.
In fact, the U.S. Food and Drug Administration (FDA) was also aware of these injuries early on. Dressen and others were told they would be cared for but they were used, the dumped when not convenient as pressure to mass vaccination the entire nation due to the pandemic superseded caring for injured people. But did COVID-19 represent an “either or” dilemma? Could not people who signed up and got the vaccine, but then sustained injury be cared for too?
This story goes back to November 2021. It was then that Ms. Friedrichsen became COVID-19 vaccine injured, and over the last year was profiled by the patient advocacy group.
TrialSite Inc., the company over TrialSite News, partnered with React19 because of the importance of ensuring that this vulnerable group receives the care needed, along with patients with long COVID and persons who sustained longer-term damage from SARS-CoV-2 itself. All people that are injured need help. Yet the COVID-19 vaccine injury represents a voice that has been silenced out, cancelled before they ever had a chance to share their story.
Source: React19
That day is now passing. TrialSite has, as of late, monitored a handful of mass media outlets, including Reuters, CBC, and now BBC, that are dipping their collective journalistic toes into the frigid waters of COVID-19 vaccine injuries. See TrialSite’s “Mainstream Media Reporting on Vaccine Injury Scandal Under Biden Admin: Claims Skyrocket & Government won’t Resolve for Decades.”
It’s happening now because of the social (and soon political) pressure building to expose this for what it is—an unjust situation.
Friedrichsen shared with Berlingske, “It scares me that the doctors just treat the symptoms because they don’t know how to treat the cause.”
Call her stubborn, Friedrichsen didn’t become an elite rower by lacking passion, determination, and focus. And even with her new vaccine-induced injury, she’s driving forward. Danish journalist Louise Lund-Sorensen writes, “But Anette Friedrichsen refuses to give up. She wants her life back. This is also why she stands up and talks about her experience.”
So how far out on a limb is the newspaper of record in Denmark willing to go?
Under “The Facts” [translated to English of course] the Daily shares the basic courtesy of both the drug regulator of Denmark (Danish Medicines Agency) and their apex research institute (Statens Serum Institut):
“Vaccination and side effects at Pfizer/BioNTech: There is no data on how many people have had vaccine damage. Pericarditis (inflammation of the lining of the heart) is considered, together with myocarditis (inflammation of the heart muscle), to be 'very rare' side effects, occurring in less than one in 10,000 people vaccinated with Pfizer/BioNTech. In total, approximately four million Danes have received the first two injections with Pfizer/BioNTech, while just over three million have received a third booster injection.” TrialSite has predicted that this situation will blow up to a national issue in the United States, a nation of over 330 million people. Why? Because there is a higher than usual serious side effect rate with the COVID-19 vaccines than with other approved vaccines. While still considered rare, the term itself, rare, becomes a relative term when over 225 million people have been fully vaccinated within a relatively short period of time. Some studies now reveal that with boosters come immune tolerance and a likely “T-cell exhaustion” that likely goes away. But that is not necessarily in every case. TrialSite estimates anywhere from 500,000 to 2 million COVID-19 vaccine injuries across America. Although Biden during September 2021 announced his sweeping vaccine mandates which were unprecedented (as was the COVID-19 vaccine in all fairness), POTUS administration didn’t even think about the consequences of the injured, nor did the NIH, FDA, or Centers for Disease Control and Prevention (CDVC). To date, only a several thousand claims have been submitted, yet just a handful of those claims have been processed by the U.S. government’s Countermeasures Injury Compensation (CICP) program. This program employs only a handful of people. Those claims will multiply, depending on one’s point of view yet another human health crisis unfolds. Legislatures must pass a law that helps fund the caring for both COVID-19 vaccine-injured and long COVID patients.
Call to Action: Check out the Berlingske. Support React19.
References
Lead author of peer reviewed research re-analysing Pfizer & Moderna trials on mRNA vaccine
@JosephFraiman calls for immediate suspension of jab due to serious harms.
‘We have conclusive evidence that the vaccines are inducing sudden cardiac death’
https://video.twimg.com/amplify_video/1612351977073025024/vid/640x360/eB_TFlGzjVCsfWV9.mp4?tag=16
calls for immediate suspension of jab due to serious harms.
Nobody calls for damage refunding of the 1-2 million RNA induced direct/indirect deaths...
Northern Ireland Politicians Declare COVID-19 Vaccine-related Deaths ‘Under Reported’
Northern Ireland’s longest-serving MP, Sir Jeffrey Donaldson, was recently confronted to publicly declare if he concurs with the Democratic Union Party (DUP) Members’ of Legislative Assembly (MLA) claims that this governing entity under the United Kingdom “under-reported’ COVID-19 vaccine injuries leading to vaccine-related deaths.
This is a controversial topic that undoubtedly is now making its way into the mainstream press of Northern Ireland. Unionist politician, Paul Frew, made recent allegations on social media that among other things, the Medicines and Healthcare products Regulatory Agency (MHRA) reported that 47 persons in Northern Ireland “had died from vaccine injury” up to September 2022. Frew went on the record that the MHRA has acknowledged that the COVID-19 vaccine injury death count is “under reported.”
This latest news doesn’t originate on some obscure fringe social media site but instead The Irish News, the largest daily as measured by circulation in Belfast, Northern Ireland. Largely “Irish nationalist” in view, the daily tries to maintain balance by offering up features from unionist writers as well.
Paul Frew, a DUP member isn’t just some fringe loon, having served as Minister for the Economy for a brief stint and an MLA for North Antrim (located near the far northern tip of Northern Ireland) since 2010. The DUP/MLA went on the record:
"These are real people who feel completely and utterly forgotten and ignored, by the government, by political reps, by medical practitioners, by the media," discussing the deaths.
The Irish Times reporter John Manley covered the story, penning that the politician shared that the UK regulatory agency said it had received 47 reports of "possible adverse reactions relating to the Covid-19 vaccines... where there was a fatal outcome".
As is the case in other parts of Europe and in America, the MHRA notes that the reactions had not been proven and "should not be interpreted as such" and disavows any claim of underreporting of COVID-19 vaccine-related deaths.
Manley’s covering of the topic reveals to the rest of the world that Frew has been a persistent critic of many Covid-related restrictions; the DUP/MLA purportedly sent a letter to the health minister Robin Swann urging an inquiry into the deaths.
Frew tweeted over this past weekend that the political and regulatory players involved have “played down” excess deaths linked to the COVID-19 vaccines.
Mainstream of Northern Ireland Hits Back
And the mainstream political society has hit back. For example, Alan Chambers, an Ulster-based Unionist health spokesperson, called Frew’s tweets “Outrageous.”
"I would have to ask whether his party leader, Sir Jeffrey Donaldson agrees with them – and if not, what action does he intend to take?” he said.
A spokesperson for the nationalist SDLP said of Frew’s comments that they "have no basis in reality" and were "best ignored".
Last week, Tory MP Andrew Bridgen lost the party whip, having "crossed a line" in his criticism of the Covid-19 vaccine. The DUP hasn’t offered up any comments.
Overview
With about 1.9 million people, Northern Ireland is part of the United Kingdom. Unionist parties in Northern Ireland align with the concept of union with Great Britain, meaning they profess loyalty to the British Crown and constitution.
Just under 80% of the Northern Irish population has received at least one dose of the COVID-19 vaccine, while 75% of the population is considered fully vaccinated. Health statistics for Northern Ireland are managed by the Northern Ireland Statistics and Research Agency.
Call to Action: Check out The Irish Times piece authored by John Manley.
References
Democrats have gone insane!!!!
Proposed Connecticut Bill Would Allow 12-Year-Olds to Get Vaccinated Without Parental Permission
TrialSite News has done a series of articles on the subject of children and vaccines. For example, Pfizer applied for Emergency Use Authorization (EUA) for their Covid vaccine for children under 12 without clinical trials for the shot. Dr. Paul Offit of the Children’s Hospital of Philadelphia, a known vaccine expert, believes there was not enough testing done on the Covid vaccine when the only available information about the jab was “mouse” data. Even a Danish health official raised alarms about parents deciding to vaccinate their children. But a proposed bill in the state of Connecticut may take the vaccination decision out of the hands of parents.
12-Year-Olds Don’t Need Parental Permission
A proposed bill in this year’s Connecticut legislative session would allow 12-year-olds to get a vaccination without parental permission. Democrat Representative Kevin Ryan proposed Bill number 5480, which would allow children 12 and over to get a vaccine even if their parents object. Currently, in Connecticut, children must have either verbal or written permission from parents to get vaccines such as Covid or HPV. “I don’t think 12-year-olds do have that mental capacity to be making their own decision,” said Nicole Malley, a Bristol, Ct. parent. Ryan said the bill is a service to one of his constituents. “As their representative, it’s my duty to express their requests and ensure their concerns have been taken seriously, especially on a health care issue,” said Ryan.
Bill Similar to Washington DC Law
Ryan’s bill is similar to one passed in Washington D.C., which allows children 11 years old and up to get a vaccine with consent from a parent or guardian. The state of Oregon also has a law allowing children who are at least 15 years old to receive medical treatment without permission from a parent or guardian.
Earlier this month, the Centers for Disease Control (CDC) reported childhood vaccinations are down for mumps, measles, and rubella. The CDC report could be the motivation for the Connecticut bill. But it’s not clear if Ryan’s bill will even make it to a legislative session. Parents, reportedly, have already been hesitant to give their younger kids the Covid vaccine. Perhaps, the proposed Connecticut law will give parents and guardians even more pause.
Unredacted NIH emails show efforts to rule out lab leak of Covid.
AS COVID-19 WAS spreading fear and spurring lockdowns across the United States in early 2020, the scientific journal Nature Medicine published a paper on March 17 titled “The Proximal Origin of SARS-CoV-2.” Written by five renowned academic scientists, it played an important early role in shaping the debate about a fiercely controversial topic: the origin of the virus that has killed millions since it emerged in Wuhan, China, in late 2019. Did it spill from animals to humans in nature, on a farm, in a market? Or did it leak from a lab like the Wuhan Institute of Virology, a leading center of coronavirus research in China? Drawing on “comparative analysis of genomic data,” the paper’s authors wrote that “our analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated construct.” Toward the end of the paper, they added, “we do not believe that any type of laboratory-based scenario is plausible” in explaining the origin of the virus. Instead, the scientists strongly favored a natural origin, arguing that the virus likely spilled from bats into humans, possibly by way of an intermediate animal host.
the origin of the virus that has killed millions since it emerged in Wuhan, China, in late 2019.
The first occurrence of CoV-19 was around March 2020 in Italy at 3 different sites. More or less at the same time in New York there have been a dozen strange flue cases same at the US West coast. Also in China the virus was present at least early 2020.
So we have two options.
- In all places Chinese slaves are held for cheap labor...
- There have been multiple tries to intentionally spread the virus.
The later is the most likely as the Japanese population did face 2 "classic" corona waves before CoV-19. So early versions have been tried in Japan that sees Millions of Chinese tourist/year...
According to a medical study Japanese people have a very high cross immunity due to these early trials...
The first occurrence of CoV-19 was around March 2020 in Italy at 3 different sites...
TIme flies... you probably mean 2019....?
So we have two options.
- In all places Chinese slaves are held for cheap labor...
- There have been multiple tries to intentionally spread the virus.
Glad its been narrowed down to only 2 options, shame they aren't mutually exclusive!
Display MoreThe first occurrence of CoV-19 was around March 2020 in Italy at 3 different sites. More or less at the same time in New York there have been a dozen strange flue cases same at the US West coast. Also in China the virus was present at least early 2020.
So we have two options.
- In all places Chinese slaves are held for cheap labor...
- There have been multiple tries to intentionally spread the virus.
The later is the most likely as the Japanese population did face 2 "classic" corona waves before CoV-19. So early versions have been tried in Japan that sees Millions of Chinese tourist/year...
According to a medical study Japanese people have a very high cross immunity due to these early trials...
More likely it was a failed vaccine trial for HIV in mid 2018 involving the Chinese military. Wastewater sampling in cities around the world detected SARS COV 2 or a virus very similar where Chinese consulate were located starting in Barcelona in mid 2018. The organization Drastic uncovered evidence off a scrubbed server in late 2020
Exclusive: How Amateur Sleuths Broke the Wuhan Lab Story and Embarrassed the Media
something to laugh at....
CDC is withholding key COVID vaccine evidence
Public authorities in the United States and elsewhere dedicated themselves, in recently years, to the promotion of vaccination against COVID-19. Dissent to the vaccination campaign was crushed by statements from public figures. “They’re killing people”, President Biden told journalists on July 16, 2021, referring to those who did not receive COVID vaccination. Social media platforms did their part by banning users who criticized COVID vaccination. Federal workers, healthcare workers, military personnel, university students and many others were subjected to mandated COVID vaccination.
Those measures were justified because the vaccines worked; they provided protection against COVID-19, it was believed. Yet doubts about the effect of COVID vaccination against the disease are growing. That is certainly the case with studies of COVID vaccination conducted by the CDC through the program COVID-NET.
COVID-NET links hospitalization cases with positive COVID-19 test results and COVID-19 vaccination status. This allows for the estimation of the effects of COVID vaccination on hospitalization. Most recently, COVID-NET reported that COVID vaccination reduces the risk of hospitalization by a factor of 16.0. CDC Director, Rochelle Walenski cited results from COVID-NET to justify continued COVID vaccination at a press briefing on February 2, 2022:
“… only 12 percent of those age 65 and over remain unvaccinated in the general population. But when we look at those over the age of 65 who are in the hospital for COVID-19, 54 percent are unvaccinated.”
Nevertheless, the statistics provided by COVID-NET are controversial. While concerns have been reported about state immunization information systems, COVID-NET uses those records exclusively to determine the COVID vaccination status. That is stated explicitly here:
“State immunization information system data were linked to cases …”
That was confirmed in an email from contractor to COVID-NET, Arthur Reingold. He stated:
“Here in California, where inputting all COVID-19 vaccinations is mandatory and we think those administering the vaccine are highly compliant, we do rely on the state registry for vaccination status. I suppose a few individuals may have been vaccinated elsewhere and the vaccination never made it into the registry, but that is likely to be a tiny percentage of individuals and not bias estimates of vaccine effectiveness to any noticeable extent.”
What is remarkable is that COVID-NET performs more extensive searches to establish the vaccination status of the cases. In a prior email, this same contractor stated:
“For COVID-NET, we track down vaccination using diverse record sources, beyond whatever the individual says.”
In other words, COVID-NET performs a search for the COVID vaccination records beyond those available in the state immunization information systems but chooses to link hospitalization cases using only records from the state immunization information systems. Most significantly, COVID-NET requests that information from the patient him/herself but ignores the response.
This is an extraordinary development - the selective use of the immunization status records in the study of the effect of COVID vaccination on hospitalization. Although the contractor stated that the magnitude of the defects in the state immunization information records, are "likely to be a tiny percentage," it is not clear how he arrived at that conclusion. A simple reassurance has little meaning.
In any case, without a valid justification for disregarding parts of the vaccination status record, COVID-NET statistics should be considered suspect. CDC has deceived the country at every turn. There is absolutely no reason to give this organization any benefit of the doubt on its controversial decision to restrict the sources for the determination of COVID vaccination status.
Cardiac Arrest and Death after COVID-19 Vaccination
Penultimate and Final "Reality" of Vaccine Serious Adverse Effects
By Peter A. McCullough, MD, MPH
Virtually every day in the news we hear about a young person, perfectly healthy, with no antecedent illness drop dead without explanation. As the cases roll in it has been my general observation that if the cardiac arrest is witnessed and there is prompt defibrillation, as in the case with Demar Hamlin, then neurologic and overall survival is possible. Out of guilt, remorse, shame and in the stupor of a COVID-19 vaccination trance, the victim and the family usually make no statement about vaccination status—something that would have been a proud point of a selfie or a tweet a few years ago. In a recent paper by Li et al, the cellular basis for the wide range of mechanisms the lead to cardiac arrest in a COVID-19 vaccinated person are described. I was alarmed that the authors considered cardiac arrest and death “common” as listed in Table 2.
But when we look at those over the age of 5 who are in the hospital for COVID-19, 54 percent are unvaccinated.”
The trick with this figure is to include all data from 2020 prior vaccination. Here - Switzerland way more vaccinates are in hospital in relation to unvaxx (10:1). So US data is payed for. Hospitals for sure get Pfizer/Moderna kick backs for false reporting.
Histological and serological features of acute liver injury after SARS-CoV-2 vaccination
Background & Aims
Liver injury with autoimmune features after vaccination against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is increasingly reported. We investigated a large international cohort of individuals with acute hepatitis arising after SARS-CoV-2 vaccination, focusing on histological and serological features.
Methods
Individuals without known pre-existing liver diseases and transaminase levels ≥5x the upper limit of normal within 3 months after any anti-SARS-CoV-2 vaccine, and available liver biopsy were included. Fifty-nine patients were recruited; 35 females; median age 54 years. They were exposed to various combinations of mRNA, vectorial, inactivated and protein-based vaccines.
Results
Liver histology showed predominantly lobular hepatitis in 45 (76%), predominantly portal hepatitis in 10 (17%), and other patterns in four (7%) cases; seven had fibrosis Ishak stage ≥3, associated with more severe interface hepatitis. Autoimmune serology, centrally tested in 31 cases, showed anti-antinuclear antibody in 23 (74%), anti-smooth muscle antibody in 19 (61%), anti-gastric parietal cells in eight (26%), anti-liver kidney microsomal antibody in four (13%), and anti-mitochondrial antibody in four (13%) cases. Ninety-one percent were treated with steroids ± azathioprine. Serum transaminase levels improved in all cases and were normal in 24/58 (41%) after 3 months, and in 30/46 (65%) after 6 months. One patient required liver transplantation. Of 15 patients re-exposed to SARS-CoV-2 vaccines, three relapsed.
Conclusion
Acute liver injury arising after SARS-CoV-2 vaccination is frequently associated with lobular hepatitis and positive autoantibodies. Whether there is a causal relationship between liver damage and SARS-CoV-2 vaccines remains to be established. A close follow-up is warranted to assess the long-term outcomes of this condition.
Now they are coming after supplements! By regulating, you no longer have control over vitamin and mineral intake. Another step in keeping you on the edge of healthy. CONTROL, POWER AND GREED!!!
New Zealand Sweeping Health Law Changes—Common Vitamins Regulated Like Medicines
An alternative health advocacy group sent out a warning about the New Zealand “Therapeutics Product Bill, which purportedly will restrict basic vitamins and minerals for example making them available only under prescription or under comparable stringent regulated conditions. From Vitamin C to Vitamin B12 and Vitamin E, to that matter traditional indigenous M?ori remedies, commonly accessible over the counter supplements and vitamins would be soon controlled by a cabal of multinational food, health and drug corporations and their captured regulatory apparatus says the controversial group the New Zealand Doctors Speaking Out with Science (NZDSOS) Is such a sweeping law underway?
Presenting itself as a medical freedom group NZDSOS’s main party line focuses on their premise that the pandemic response wasn’t just tied to SARS-CoV-2 but rather, more deeper, disturbing problem of industry capture of the medical /health sector arguing that populations are “…lulled by big food, big pharma and big tech into a trance of increasing obedience to these industries while they mined us for resources.”
Ramblings of the extreme and paranoid or commonsense talk in a new age of top-down control over everything health? With a new law that further controls what people can do for their own health, the group of independent doctors point at a changing law as proof of this overall usurpation of medical freedom.
According to a NZDSOS communication, the Therapeutics Product bill…will restrict access to a wide array of supplements and vitamins including:
Vitamin C, aloe vera (even in your garden), cinnamon, fish oil, n-acetyl cysteine, Vitamin B12, magnesium, kawa-kawa, zinc, selenium, astragalus, niacin, calcium, bilberry, Vitamin A, iodine, crampbark, thiamine, iron, lavender, riboflavin, thyme, oats, valerian, chromium, ginger, coenzyme Q10, glutamine, chaste tree, echinacea, pantothenic acid, St John's wort, slippery elm, turmeric, soy, probiotics, folate, licorice, garlic, flaxseed oil, cocoa, cranberry, pyridoxine, cloves, celery, carnitine, evening primrose oil, Vitamin D, New Zealand green lip mussel, psyllium, Vitamin E, tea, quercetin, rosemary….
So, what is the bill?
According to the New Zealand Parliament’s website is intended to replace the Medicines Act 1981 as well as the Dietary Supplements Regulations 1985 “to provide comprehensive, risk-proportionate regulation of therapeutic products, such as medicines, medical devices, natural health products and active pharmaceutical ingredients.”
Sponsored by MP Andrew Little, a politician and former trade union official currently serving as Health and Minister for Treaty of Waitangi Negotiations. Interestingly Little is also Minister for the Government Communications Security Bureau as well as the New Zealand Intelligence Service. According to reports Little himself was diagnosed with prostate cancer over a decade ago but anti-cancer treatments cleared the cancer.
By mid-December 2022 the New Zealand Parliament published on its website that the Chair of the Health Committee called for public submission on the Therapeutics Products Bill due by Wednesday, February 15, 2023 which leaves just 24 days.
The Therapeutic Products Bill was introduced to Parliament on 30 November 2022 and has been referred to the Health Select Committee. Submissions on the Bill can be made via the New Zealand Parliament website . Submissions on the Bill close 11.59pm, Wednesday 15 February 2023
The Bill represents a sweeping change for how drugs, medicines and food and supplements for example are regulated in this English-speaking nation of 5.12 million people.
That’s because although today Natural health products are regulated by the Dietary Supplements Regulations 1985 under the Food Act 2014, that will go away, replaced by a sweeping change. The proposed bill repeals most provisions of the Medicines Act, making an exception relating to pharmacy ownership, and revoke the regulations made under the Act. It would also revoke the Dietary Supplements Regulations.
Changes that the bill proposes include:
?requiring therapeutic products to receive a market authorization before they could be imported into, exported from, or supplied in New Zealand
providing for the regulation of a range of controlled activities
establishing a Therapeutics Products Regulator
Why are New Zealand politicians proposing such sweeping changes to the law?
According to the New Zealand Ministry of Health “natural health products” will fall under the “Therapeutic Products” umbrella, and thus subject a global industry worth $152+ billion in 2022 alone to regulatory oversight in New Zealand.
Under the sweeping changes “Therapeutic Products” include everything that can be considered not only a medicine, but also medical device and natural health products—those health products New Zealanders use day-to-day across all parts of the health system.
The government appears concerned for its citizen’ safety. That’s because the Ministry of Health declares:
“Therapeutic products can present serious risks of harm, especially if used inappropriately. Ensuring the benefits of therapeutic products outweigh possible risks of harm to consumers is fundamental to the delivery of high-quality health and disability services.”
Furthermore, this Bill if enacted regulates how products are manufactured, tested, imported, promoted, supplied and exported. Interestingly enough the Ministry of Health avoids contentious examples, such as Vitamin C rather centering the reader’s attention on the expected targets such as medicines (gene and cell therapies for example) to medical devices.
In some cases, the regulatory change makes sense, for example medical devices, and gene, cell tissue therapies aren’t fully regulated in New Zealand.
Controversially the Ministry declares “Natural health products are also going to be included under the Bill” along with providing a link to what products would fall under this potential regulated category. They define Natural Health Products as:
“Natural health products support health and wellness, and are made from natural ingredients, or synthetic equivalents such as synthetic vitamins.
Natural health products include herbal remedies (in the form of capsules, tonics, and skin creams), vitamin and mineral supplements, traditional M?ori remedies, traditional Chinese medicine, homeopathic remedies, and some remedies based on animal products, such as deer velvet and fish oil capsules.
Supplemented foods, such as bread or juice fortified with vitamins and minerals, are not considered natural health products. They are regulated by the Ministry for Primary Industries.”
But why include so many products that were traditionally available to people over the counter including indigenous M?ori remedies?
But what’s the Ministry’s rationale?
The New Zealand Ministry of Health makes this sweeping change about benefiting the consumer—empowering the patient and consumer to force transparency for example in ingredients and manufacturing information so that health consumers “can make informed decisions about the products they use” and of course the agency touts “access safe and high-quality products.”
While the Ministry acknowledges that natural health products are typically lower risk than medicines nonetheless the agency declares they are “not risk free.”
So, the agency claims that assuming the law is passed natural health products now will undergo the same regulatory scrutiny as the pharmaceutical industry which they declare helps ensure:
products contain safe ingredients at a safe dose
high quality manufacturing processes are in place to provide assurance that products are not contaminated
product information is clear on the use and recommended dose
health claims are based on evidence
New Zealand producers are in a positive position in the global marketplace
Of course, this sweeping change in law would place many products that are overwhelmingly safe, subjecting them to more regulatory processes and oversight which all but ensures over time the cost of production increases, which means price increases.
Greater safety of course is important and should be a fundamental goal of government regulatory agencies. Is a line being crossed here? Those Kiwis that have something to say should submit comments—thus far TrialSite couldn’t find any
