Thread by @Averixus

The UK Government is holding a consultation about changing some regulations for the purpose of getting potential future COVID-19 vaccines and treatments out to people more quickly. The consultation is only open until the end of 18th September (Friday). /1

You can read the full explanatory text here, and respond by clicking "respond online" at the very bottom of the page. The online form asks for some personal and demographic information and then gives free text boxes to talk about the proposals. /2 gov.uk/government/con…

There are five proposed changes in the consultation.

1. Temporary authorisation of the supply of unlicensed products.

In spite of the name, this proposal would not create a new ability to authorise unlicensed medical supplies. In fact that power already exists in law. /3

The people in charge of licensing medicines are already able to temporarily authorise an unlicensed medicine in response to urgent public health situations (like infectious illnesses, chemical toxins, or radiation).

The proposed change to this law is to add more detail. /4

The change would be to explicitly say that, when unlicensed medicines are temporarily allowed, they can still be subject to conditions. This makes it clear that the licensing authorities will still be able to ensure medicines are safe before allowing them to be used. /5

2.Civil liability and immunity.

Again, this change would not create a new immunity for unlicensed medicines. The existing law already says that the people involved in making and administering unlicensed medicines will have some protection from being sued if there are problems./6

This existing protection does not provide complete immunity. If an unlicensed medicine turns out to be unsafe or sufficiently breaches the conditions that were set when it was allowed, the immunity no longer applies.

The proposed change is to add a few clarifications. /7

2a) The first clarification is to specify that pharmaceutical companies who bring out the unlicensed medicines have the same level of protection as the manufacturers and people who administer it. /8

2b) The second clarification is to define exactly what counts as a sufficient breach of conditions to forfeit the existing immunity.

The proposal is to specify that the breach would have to be considered sufficient by "a reasonable person". /9

That kind of imaginary person is common in laws like this. The proposal is considering two main options. One is to just say "a reasonable person", and one is to say "a reasonable person with an interest in placing medicinal products on the market". /10

So the question to consider is whether a 'serious breach' of conditions should be defined based on what an average person on the street knows, or based on what a person in the medical/pharmaceutical industry knows. /11

2c) The third clarification is to specify that only people who are responsible for a breach would lose their immunity. This clarification would make it clear that for example, if a manufacturer makes an unsafe product, the people distributing it are still protected. /12

2d) The fourth clarification is to specify that anyone who administers the medicine will have the same immunity. This would make it clear that if non-medical professionals are asked to administer a medicine they would be protected like any doctors and nurses administering it./13

2c) The last clarification is to specify what the potential punishment is for breaching the conditions. The proposal would make the punishment the same as it currently is for breaching the conditions of a licensed medicine (an unlimited fine and 2 years in jail). /14

3. Proposed expansion to the workforce eligible to administer vaccinations.

This part has three proposed changes, which are all different ways of making it possible for more people to administer vaccines. /15

3a) There is already a way to allow medicines to be administered by healthcare professionals other than doctors. The proposal is to allow temporarily-authorised unlicensed medicines to go through the same process. /16

3b) The proposal would add a new protocol which is similar to the existing one above, that's specifically intended to allow non-healthcare professionals to administer temporarily-authorised vaccines. /17

3c) The proposal would expand the definition of who is normally entitled to administer vaccines, so that it would include occupational health workers, midwives, pharmacists, paramedics, and various others in medical and related fields. /18

4. Vaccine promotion.

It's currently not possible to promote an unlicensed medicine to the public. This proposal would allow temporarily-authorised medicines and vaccines to be promoted in the same way as licensed medicines. /19

5. Make provisions for wholesale dealing of vaccines.

Currently a special license is required to distribute vaccines in bulk. This means that if one hospital has spares and another hospital doesn't have enough, it's complicated and slow to redistribute them. /20

This proposal would make medical organisations exempt from needing this special license to redistribute medicines, so they would be able to move them around to where they're needed more quickly. /21

That's the end of the proposed changes in the consultation. I noticed some people seemed scared about what the proposed changes involve, so I wanted to write them out in a slightly shorter and simpler way. I hope this helps people to understand and respond to the consultation./22

Here is the link again for convenience. 23/23 gov.uk/government/con…

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