John Campbell has made an excellent video summarising the proposed changes to the WHO International Health Regulations. I have summarised some of the changes below, including most of ones John Campbell mentions as well as one or two interesting changes that I noticed as well.
The WHO International Health Regulation Amendments
The WHO is amending the International Health Regulations. Many of the changes purely and simply increase the power of the WHO and give them the ability to compel member states to follow their ‘advice.’ I have gone through some of the changes they want to make below; additions are in bold. Deletions are struck through. Parts I have wanted to accentuate are in a larger font.
Section 1: Health products now include gene therapy and databases
The WHO advice now defines health products, which the International Health Regulations (IHR) did not do so before, and the definition of health products now includes gene therapy and databases. In the light of subsequent changes to the regulations, this development is very troubling to me: will these databases include lists of people who are non-compliant with vaccination, for instance? That this would definitely be one of the uses of the database is indicated by the phrase saying that the databases are developed to solve problems relating to the application or usage of health products.
1. For the purposes of the International Health Regulations (hereinafter “the IHR” or “Regulations”):
“health products” include therapeutics, vaccines, medical devices, personal protective equipment, diagnostics, assistive products, cell- and gene-based therapies, and their components, materials, or parts.”
“health products” include medicines, vaccines, medical devices, diagnostics, assistive products, cell- and gene-based therapies, and other health technologies, but not limited to this course“health technologies and know-how” includes organized set or combination of knowledge, skills, health products, procedures, databases and systems developed to solve a health problem and improve quality of life, including those relating to development or manufacture of health products or their combination, its application or usage. “Health technologies” are interchangeably used as “health care technologies”.
Removal of the words ‘non-binding’: the WHO’s Regulations are now binding.
They are removing the words, ‘non binding’ Why? Obviously so that the WHO’s Regulations and advice will now be binding on member states.
“standing recommendation” means
non-bindingadvice issued by WHO for specific ongoing public health risks pursuant to Article 16 regarding appropriate health measures for routine or periodic application needed to prevent or reduce the international spread of disease and minimize interference with international traffic
“temporary recommendation” meansnon-bindingadvice issued by WHO pursuant to Article 15 for application on a time-limited, risk-specific basis, in response to a public health emergency of international concern, so as to prevent or reduce the international spread of disease and minimize interference with international traffic;
WHO Regulations to address anything that might have the potential to impact public health, in other words, everything.
They have removed the requirement that their Regulations address public health risk, and widened the Regulations to include “all risks that have the potential to impact public health.” That means, everything. Absolutely any area of life might have the potential to impact public health.
The purpose and scope of these Regulations are to prevent, protect against, prepare, control and provide a public health response to the international spread of diseases including through health systems readiness and resilience in ways that are commensurate with and restricted to
public health riskall risks with a potential to impact public health,
The WHO are allowed to interfere in human rights if they think it’s necessary.
And their 2005 Regulations said they must avoid ‘unnecessary’ interference with traffic and trade - now they must avoid ‘unnecessary’ interference with human rights as well. This change begs the question: what would be a ‘necessary’ interference in human rights? There is nothing that can be a ‘necessary’ interference in human rights. Human rights override every other consideration. In the light of the deletion of human rights in Article 3, this is a very suspicious change, and allows the WHO to interfere in human rights.
and which avoid unnecessary interference with international traffic and trade, livelihoods, human rights, and equitable access to health products and health care technologies and know how.
These are the changes to Article 3 I’m talking about which are particularly worrying: WHO are no longer required to respect the dignity, human rights and fundamental freedoms of persons.
Article 3 Principles
1. The implementation of these Regulations
shall be with full respect for the dignity, human rights and fundamental freedoms of personsbased on the principles of equity, inclusivity, coherence and in accordance with their common but differentiated responsibilities of the States Parties, taking into consideration their social and economic development.
In Article 9 they are removing the requirement that the WHO consult with State Parties before they take action:
1. WHO may take into account reports from sources other than notifications or consultations and shall assess these reports according to established epidemiological principles and then communicate information on the event to the State Party in whose territory the event is allegedly occurring.
Before taking any action based on such reports, WHO shall consult with and attempt to obtain verification from the State Party in whose territory the event is allegedly occurring in accordance with the procedure set forth in Article 10. To this end,WHO shall make the information received available to the States Parties and only where it is duly justified may WHO maintain the confidentiality of the source. This information will be used in accordance with the procedure set forth in Article 11.
In Article 10 they no longer have to consult with State parties before they share information with other States or start ‘collaborating’ with the State concerned. I don’t think I like the sound of ‘collaboration’ that doesn’t take into account the country’s own views:
4. If the State Party does not accept the offer of collaboration within 48 hours , WHO
mayshall , when justified by the magnitude of the public health risk, immediately share with other States Parties the information available to it, whilst encouraging the State Party to accept the offer of collaboration by WHO,taking into account the views of the State Party concerned.
The same tendency is apparent in Article 13 paragraph 3; the country no longer asks for assistance and the WHO no longer have to collaborate. The WHO tell the State Party the assistance they will be providing. If the country rejects the assistance, they have to give the rationale for such a rejection - they have to explain themselves to the WHO, as though the WHO was in charge and the nation concerned must justify their disobedience:
3.
At the request of a State Party,WHO shallcollaboratearticulate clearly defined assistance to a State Party offer assistance to a State Party in the response to public health risks and other events by providing technical guidance, health products, technologies, know-how,deployment of civil medical personals, and assistance and by assessing the effectiveness of the control measures in place, including the mobilization of international teams of experts for on-site assistance, when necessary, and if required cooperate with said Member State in seeking support and international financial assistance to facilitate the containment of the risk at source. The State Party shall accept or reject such an offer of assistance within 48 hours and, in the case of rejection of such an offer, shall provide to WHO its rationale for the rejection, which WHO shall share with other States Parties. WHO will also share any request for assistance by the affected State party that could not be met by WHO.
Article 13 Paragraph 4 also requires the State Party to justify themselves to the WHO if they don’t want the WHO’s ‘assistance’, like an intransigent child. And the country must allow the WHO in to the country onto ‘relevant sites’, and if they don’t want to do that, they have to explain themselves as well. Mirroring the other coercive provisions, the WHO shall offer assistance - no longer is it may offer assistance.
4. If WHO, in consultation with the States Parties concerned as provided in Article 12, determines that a public health emergency of international concern is occurring, it
mayshall offer, in addition to the support indicated in paragraph 3 of this Article, further assistance to the State Party, including an assessment of the severity of the international risk and the adequacy of control measures. Such collaboration may include the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer. The State Party shall accept or reject such an offer of assistance within 48 hours and, in the case of rejection of such an offer, shall provide to WHO its rationale for the rejection, which WHO shall share with other States Parties. Regarding on-site assessments, in compliance with its national law, a State Party shall make reasonable efforts to facilitate short-term access to relevant sites; in the event of a denial, it shall provide its rationale for the denial of access.
The WHO decides what is Reliable Information
In Article 11 they have changed the title from ‘Provision of Information’ to ‘Exchange of Information’ and included the dubious phrase ‘a reliable platform for information exchange’, which on the surface means a platform that won’t go down, but in double-speak surely means censorship of opposing views. As Dr. John Campbell points out in his excellent summary, the WHO will decide what is reliable information. Member countries will not. Member health professionals or hospitals will not decide what is reliable information. Your Doctor will not decide what is reliable information. The WHO will be the arbiters of truth.
Article 11
Provision of information by WHOExchange of information1. Subject to paragraph 2 of this Article, WHO shall send to all States Parties and, as appropriate, to relevant UN and
intergovernmentalinternational and regional organizations, as soon as possible and by the most efficient means available, in confidence, such public health information which it has received under Articles 5 to 10 inclusive or which is available in the public domain, / ALT or which is otherwise available and whose validity is appropriately assessed by WHO and which is necessary to enable States Parties to respond to a public health risk. WHOshouldshall communicate information to other States Parties that might help them in preventing the occurrence of similar incidents. For this purpose, WHO shall facilitate the exchange of information between States Parties and ensure that the Event Information Site For National IHR Focal Points offers a secure and reliable platform for information exchange among the WHO and States Parties and allows for interoperability with relevant data information systems.
The requirement for interoperability at the bottom of the aforementioned paragraph is also very suspicious: the implication of this data sharing is that WHO will be putting their long nose into member countries’ public health databases, which contain the private health information of citizens of a sovereign nation.
In article 12, the Director-General can decide that something is a potential health emergency. It doesn’t even have to be an actual health emergency for the WHO to start sticking their noses in.
2. If the Director-General considers, based on an assessment under these Regulations, that a potential or actual public health emergency of international concern is occurring, the Director-General shall notify all States Parties and seek to consult with the State Party in whose territory the event arises regarding this preliminary determination and may, in accordance with the procedure set forth in Article 49, seek the views of the Committee established under Article 48 (hereinafter the “Emergency Committee”) . If the Director-General determines that the event constitutes a public health emergency of international concern, and the State Party are in agreement regarding this determination, the Director-General shall notify all the States Parties, in accordance with the procedure set forth in Article 49, seek the views of the Committee established under Article 48 (hereinafter the “Emergency Committee”) on appropriate temporary recommendations.
FENSA Provisions
There is a new paragraph number 7 in Article 12 that is very peculiar at first sight. Like a number of provisions in this ‘contract’, on the surface it appears to mean one thing, but on further probing actually means the opposite.
New 7. In case of any engagement with non-State actors in WHO’s public health response to PHEIC situation, WHO shall follow the provisions of Framework for Engagement of Non-State Actors (FENSA). Any departure from FENSA provisions shall be consistent with paragraph 73 of FENSA.
This paragraph looks as though it’s limiting WHO’s power to some FENSA provisions. However, I looked it up and FENSA Paragraph 73 basically says that the Director-General has ‘flexibility.’ Paragraph 7, as far as I can tell, allows the WHO Director-General a right to do anything he wants when it concerns Non-State Actors. Consider the influence some Non-State Actors have over the WHO, for instance the Bill and Melinda Gates Foundation is the biggest private donor and has donated more money to the WHO than most countries in any given year except for the US and Germany. This provision clearly allows the WHO Director-General to collaborate in any way whatsoever with Non-State Actors such as the Bill and Melinda Gates Foundation.
New Article 13A - Countries undertake to do what the WHO tells them to do.
In the new Article 13A paragraph 1, the member countries recognise the WHO as the coordinating authority of their health response, and undertake to follow everything WHO recommendations.
1. State Parties recognize WHO as the guidance and coordinating authority of international public health response during public health Emergency of International Concern and undertake to follow WHO’s recommendations in their international public health response.
Article 13A (13B?) also gives WHO the power to take control of the resources, the manufacturing processes.
1. Immediately after the determination of a public health emergency of international concern under Article 12, the Director General shall make an immediate assessment of availability and affordability of required health products and make recommendations, including an allocation mechanism, to avoid any potential shortages of health products and technologies pursuant to Article 15 or 16 as appropriate.
2. States Parties shall co-operate with each other and WHO to comply with such recommendations pursuant to paragraph 1 and shall take measures to ensure timely availability and affordability of required health products such as diagnostics, therapeutics, vaccines, and other medical devices required for the effective response to a public health emergency of international concern.
And WHO will take control of the intellectual property.
3. States Parties shall provide, in their intellectual property laws and related laws and regulations, exemptions and limitations to the exclusive rights of intellectual property holders to facilitate the manufacture, export and import of the required health products, including their materials and components.
Also paragraph 7 in the same article:
7. The States Parties shall take measures to ensure that the activities of non-state actors, especially the manufacturers and those claiming associated intellectual property rights, do not conflict with the right to the highest attainable standard of health and these Regulations and are in compliance with measures taken by the WHO and the States Parties under this provision, which includes:
a) to comply with WHO recommended measures including allocation mechanism made pursuant to paragraph 1.
b) to donate a certain percentage of their production at the request of WHO.
c) to publish the pricing policy transparently.
d) to share the technologies, know-how for the diversification of production.
e) to deposit cell-lines or share other details required by WHO repositories or database established pursuant to paragraph 5.
f) to submit regulatory dossiers concerning safety and efficacy, and manufacturing and quality control processes, when called for by the States Parties or WHO.
Article 13A (?B ) paragraph 5 - We will never know the safety and efficacy of WHO treatments because our own governments will not even be allowed to share the data with us.
This one is a doozy: the WHO will take control of the efficacy and safety data and it looks like the State Parties will not be allowed to share the data with third parties. In other words, the WHO will be able to disseminate the data about whether the vaccines are safe and effective, but the requesting country will not be able to share this data with their own citizens.
5. Upon request of a State Party, other States Parties or WHO shall rapidly cooperate and share relevant regulatory dossiers submitted by manufacturers concerning safety and efficacy, and manufacturing and quality control processes, within 30 days. The dossiers received by a requesting State Party shall be solely used by their regulatory authorities and manufacturers designated by the requesting State Party for the purposes of accelerating the manufacture and supply of product(s) or technology(ies) as well as expediting their regulatory approval. Requesting State Party shall take measures to prevent designated manufacturer(s) from disclosing such information to a third- party(ies) except for the purposes of producing and supplying any materials or components to the manufacturer(s) under a contract with non-disclosure provisions.
THE WHO COMPLIANCE COMMITTEE
The member nations shall set up a Compliance Committee, to report to the WHO and the other State Parties how well they are complying.
NEW Chapter IV (Article 53 bis-quater): The Compliance Committee 53 bis Terms of reference and composition
1. The State Parties shall establish a Compliance Committee that shall be responsible for:
(a) Considering information submitted to it by WHO and States Parties relating to compliance with obligations under these Regulations;
(b) Monitoring, advising on, and/or facilitating assistance on matters relating to compliance with a view to assisting States Parties to comply with obligations under these Regulations;
(c) Promoting compliance by addressing concerns raised by States Parties regarding implementation of, and compliance with, obligations under these Regulations; and
(d) Submitting an annual report to each Health Assembly describing:
(i) The work of the Compliance Committee during the reporting period;
(ii) The concerns regarding non-compliance during the reporting period; and (iii) Any conclusions and recommendations of the Committee.2. The Compliance Committee shall be authorized to:
(a) Request further information on matters under its consideration;(b) Undertake, with the consent of any State Party concerned, information gathering in the territory of that State Party;
(c) Consider any relevant information submitted to it;
(d) Seek the services of experts and advisers, including representatives of NGOs or members of the public, as appropriate; and
(e) Make recommendations to a State Party concerned and/or WHO regarding how the State Party may improve compliance and any recommended technical assistance and financial support.
3. The Members of the Compliance Committee shall be appointed by States Parties from each Region, comprising six government experts from each Region. The Compliance Committee shall be appointed for four-year terms and meet three times per year.
53 ter. Conduct of business
1. The Compliance Committee shall strive to make its recommendations on the basis of consensus.
2. The Compliance Committee may request the Director-General to invite representatives of the United Nations and its specialized agencies and other relevant intergovernmental organizations or nongovernmental organizations in official relations with WHO to designate representatives to attend the Committee sessions, where appropriate to address a specific issue under consideration. Such representatives, with the consent of the Chairperson, make statements on the subjects under discussion.
53 quarter Reports
1. For each session, the Compliance Committee shall prepare a report setting forth the Committee’s views and advice. This report shall be approved by the Compliance Committee before the end of the session. Its views and advice shall not commit WHO, States Parties, or other entities and shall be formulated as advice to the relevant State Party.
2. If the Compliance Committee is not unanimous in its findings, any member shall be entitled to express his or her dissenting professional views in an individual or group report, which shall state the reasons why a divergent opinion is held and shall form part of the Committee’s report.
3. The Compliance Committee’s report shall be submitted to all States Parties and to the Director- General, who shall submit reports and advice of the Compliance Committee, to the Health Assembly or the Executive Board, as well as any relevant committees, for consideration, as appropriate.
Director-General of the World Health Organization, Dr Tedros Tedros Adhanom Tedros Ghebreyesus Tedros. Almighty, all knowing, always right. Of course.