Thread by @GalG____

🧵1/ Procedure 29: I’m writing this in English as well because it’s so important to understand the tragedy of the #IsraePfizerDeal - that made my people defined as “The lab of the world” - and then affected the rest of the world as an unprecedented medical experiment on humans >>

2/ Much of the wording in the additional redacted agreements in the Israel-Pfizer deal (just revealed) refers to approval under "Procedure 29" - as the Israeli equivalent of the EUA and emergency approvals of the EC. What is this procedure, and what did the MOH do with it? >>

3/ As a reminder, the Israeli MOH decided to independently approve, as a pioneering & bold regulator - Pfizer's product, before everyone else, already on 8.12.2020
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4/ This approval was a few days after the final deal between Israel & Pfizer was signed (the Manufacturing and Supply agreement) and a few days •before• Pfizer received the first EUA. You can read about here in the article with the important timeline:
rtmag.co.il/english/we-can…
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5/ The Israeli "Import Approval" was based on Regulation 29 of the Pharmacists' Regulations (preparations)- a procedure that allows the importation of medicines and their marketing/use in Israel without being registered in their country of origin by other means of importation.
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6/ Article 29(a)(9) in that regulation refers to the case of an epidemic or contagious disease, among others - as an exception that allows the importation of medical products in this way, which is not the standard procedure for registered medicines

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7/The procedural law under article 29a(9) includes guidelines for the head of MOH which states that the decision of the Head of the Ministry of Health in granting approval according to the aforementioned procedure 29 must be based on the detailed conditions (attached)

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8/ Among other things, it was determined as a condition that:

“The manager's opinion was satisfied that the benefit of using the product outweighs the risk involved"

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9/ In the vague and insulting approval that was presented by the director general of the ministry Dr. Hezi Levy (in approval of perhaps the largest and most unusual deal ever made by the Israeli Ministry of Health) - the “Import Approval” it states:

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10/ "This decision of mine is based on the information provided by Pfizer in the EUA file, scientific publications, information from other regulatory authorities and based on consultations with the relevant parties.”

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11/ Anyone who stumbled upon the wording of this poor approval and the vague, abstract and completely empty "reasoning" could easily conclude that Mr. Levy was answering a random and meaningless question on the street regarding his father's vegetable stand. But -

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12/ This reasoning is of great importance in the concepts of administrative law and the responsibility imposed on the Ministry of Health as a PUBLIC AUTHORITY in general and in this deal in particular >>

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13/ Among other things, in order to examine the possibility of exceeding authority (Ultra Vires) by reasonableness of administrative decisions, it is necessary to examine whether there was application of discretionary powers in irrational and wrong way etc.

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14/ How can we know what "consultations" include and who those "relevant parties" are?

But worse than that - the Israeli Director General of the Ministry of Health claimed that he relied on the information submitted at the EUA's request, on scientific publications, etc.

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15/ This particular reasoning is of great importance because it is supposed to establish the requirement under the Israeli law in the regulation and procedure above, according to which "The manager's opinion was satisfied that >>

16/ the benefit of using the product outweighs the risk involved" -

HOW was his opinion satisfied at this stage?!
How could it ?!

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17/ HOW- before phase 3 of the clinical trial, before the EUA, and whilst signing on a “Purchaser Acknowledgment” statement in the M&S agreements that the Ministry of Health knows that the long-term effects, efficacy and adverse effects of this product ARE NOT currently known

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18/ only a week later, this very same person, then head of the Ministry of Health, issues the FIRST APPROVAL IN THE WORLD for the use of this product, in a procedure in which he HAD TO BE CONVINCED That the benefits outweigh the risks?

19/ HOW, for God's sake, can the Israeli regulator announce that he has made up his mind regarding the weighing of the risks - when at the same time he declares that the risks are NOT YET KNOWN?!

Then, they went to the Israeli public with "safe and effective" propaganda.

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20/ Back to the references in the newly revealed agreements to the approval procedure 29 and its importance.

In the Binding Term Sheet (BTS) from Nov. 2020 it was established that without the approval of Regulation 29 - Pfizer is not obligated to -
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21/ provide the doses pre-ordered by Israel, and if the approval is not given because of the Ministry of Health then there will be no refund either.

Isn't this a mechanism to bind the regulator’s discretion?
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22/ The M&S agreement from Dec. 1, 2020 also explicitly emphasizes: without approval 29 there will be no distribution of the product in Israel. The agreement had already been signed and a very heavy advance was paid.

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23/ Can we really believe that a regulator that signs this agreement/deal will have any discretion a week later when signing an approval that enables this deal’s very existence?
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24/ The M&S agreement also stated that "conditional approvals" from the FDA and the EU- are needed to obtain an Israeli approval (procedure 29).

Despite this - they approved the Pfizer product in Israel BEFORE AND WITHOUT any regulatory approval from another countries
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25/ Returning to my basic question and with it I will conclude:

How can you weigh risk versus benefit when you state that you know the risks and the benefits- are not yet known?

👉🏻 Full story and important links to the documents:

https://twitter.com/GalG____/status/1627675704665014274

26/ If I remember correctly, there was a petition to the Israeli High Court on this issue of procedure 29 based on the Information agreement (which was published first and also refers to procedure 29) - and if I'm not mistaken, it was dismissed without deliberation 😒

27/ Final note:
There will be much more to say on these new documents revealed in the #IsraelPfizerDeal, I published them ASA I received them because they belong in the public domain and were kept from it for too long. Hopefully many will analyze them in the following days.