Covid vaccines consultation

growstuff I'm still not clear why new legislation is needed if unlicensed drugs can already be prescribed. Does anybody know what's new?

These extracts from the consultation document might clarify this a bit:

Regulation 174 of the HMRs allows the licensing authority to permit a temporary authorisation for the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat – the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation.
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A COVID-19 vaccine would only be authorised in this way if the licensing authority was satisfied that there was sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine, in the particular context in which the licensing authority was asked to take that decision.
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The proposed amendments build on and add to the existing text for regulation 174, which we are not proposing to alter. While it is implicit that under regulation 174, as currently drafted, a decision to authorise the supply an unlicensed medicinal product could carry certain conditions, this is not expressly articulated.

To provide transparency, we propose to amend the HMRs to make it explicit that the supply of products, including COVID-19 vaccines, which is temporarily authorised under regulation 174 may be subject to conditions. The imposition of conditions enables the licensing authority to define the safeguards that are a pre-requisite for the safe supply and use of the product and without which authorisation would not be valid. This can range from specifying whom the product is suitable for, setting batch testing and quality assurance standards, and ensuring that appropriate storage is in place throughout the supply chain. Given its importance, it is appropriate to articulate this element of the licensing authority’s decision-making more fully in the legislation.

There is a lot more there but I don't want to copy everything. What I note from the document is that it is still the licencing authority which would decide if a vaccine should be distributed. Having read part of the document, I actually feel better about the whole thing. I'll probably have a go at the rest of the document this afternoon. Of course I am not a specialist in this area.

You could be right. I have a feeling (but could be wrong) that doctors need authorisation to prescribe off-licence, so maybe it bypasses that.

I posted that I thought it might be about scale. I have a vague memory of off licence prescribing being very focused on individual patients and individual prescribing clinicians. I don’t know of an example in recent times where an off licence medicine has been prescribed to huge numbers of patients in a blanket fashion. Maybe that’s the issue

I share your concern. I've always accepted every vaccination going and I would probably accept a Covid-19 one, but I'll certainly want to check it out. It's sad that I really don't trust the government at all.

growstuff

Why unlicensed drugs are sometimes prescribed:

www.ouh.nhs.uk/patient-guide/leaflets/files/12048Punlicensed.pdf

I'm still not clear why new legislation is needed if unlicensed drugs can already be prescribed. Does anybody know what's new?

That is exactly why I’m worried

Why unlicensed drugs are sometimes prescribed:

www.ouh.nhs.uk/patient-guide/leaflets/files/12048Punlicensed.pdf

I'm still not clear why new legislation is needed if unlicensed drugs can already be prescribed. Does anybody know what's new?

I am concerned that playing fast and loose with medicines is part of Cummings’, ERG and like minded individuals plan for a “bonfire of regulations”

From my oracle ?

She isn’t remotely political, so may not be aware of the latest wheeze by the government.

“I assume this is related to COVID. All drugs cannot make market without trials. This is written in law (Thalidomide, and various other cases ) and after that all drugs must be tested to a standard. Each country has regulations determining what that testing must be. MHRA have what we all call the “Orange Guide”. These standards are in place and are the same whatever the drug.
Licensing involves a review of the trials work and a review of the facility where the drug is to be produced by trained auditors. I suppose bypassing licensing would mean not carrying out the audits and therefore there would be no ongoing assurance for the patient that their drug is manufactured to the conditions laid out in the Orange Guide (or equivalent In other countries). Licenses are maintained with regular (approx 3 year) audits.
Given the legal cases I can’t see that a government would be allowed to completely bypass licensing. They may be able to expediate certain parts of the licensing process but that would be all”

I’m no further forward really☹️

I think the issue of drugs being used off-licence is related to scale surely?

M0nica

It is not uncommon for dispensations to be sought and granted to use drugs in the licensing process but not yet licensed where there is a critical need or where it is being used in a situation it is not licensed. Many a critically ill child has been returned to health by doctors, in a last desperate effort giving the child a drug only licensed for adults.

I believe during the Ebola epidemic, some vaccines were used ahead of licensing, the need was so desperate.

Thanks for this information M0nica, its very relevant to the current situation.

M0nica

It is not uncommon for dispensations to be sought and granted to use drugs in the licensing process but not yet licensed where there is a critical need or where it is being used in a situation it is not licensed. Many a critically ill child has been returned to health by doctors, in a last desperate effort giving the child a drug only licensed for adults.

I believe during the Ebola epidemic, some vaccines were used ahead of licensing, the need was so desperate.

I know

It is not uncommon for dispensations to be sought and granted to use drugs in the licensing process but not yet licensed where there is a critical need or where it is being used in a situation it is not licensed. Many a critically ill child has been returned to health by doctors, in a last desperate effort giving the child a drug only licensed for adults.

I believe during the Ebola epidemic, some vaccines were used ahead of licensing, the need was so desperate.

Furret

I have put my name forward for trialling the Oxford vaccine.

That is so admirable!

I’m too frightened as DH is high risk and I feel too anxious about possibly passing it on. I know it doesn’t make sense, but there you are.

I have put my name forward for trialling the Oxford vaccine.

Interestingly I do know that the USA licensing standards are higher than the UKs.

So I’d be happier having a vaccine produced and licensed by the USA than a non-licensed U.K. one.

I shall consult my oracle?

Hmm! I am not convinced, must look further into this.

Because licencing isn't about the testing of the drug. It's about giving commercial companies the right to manufacture and market it. I would want to know something was tested and approved, but I would not personally lose any sleep over the licencing aspect.

We obviously have to have assurances about safety and efficacy, but licencing is not necessary for that.

Alegrias

And that of course is your prerogative WW2

"A drug is licensed only if strict quality and safety standards are met." True. But a drug which has met strict quality and safety standards is not necessarily licenced.

How would you know it had?

And that of course is your prerogative WW2

"A drug is licensed only if strict quality and safety standards are met." True. But a drug which has met strict quality and safety standards is not necessarily licenced.

A drug is licensed only if strict quality and safety standards are met.

Personally I would rather have a licensed vaccine than an unlicensed vaccine.

Alegrias

Whitewavemark2

The point about licensing drugs is that Johnson’s government is consulting with the idea of by-passing the licensing process. It is also intending to pass legislation that will prevent an individual suing the government if she gets sick from one of these unlicensed vaccinations.

On the first point WWM2, they are only proposing to allow the use of a vaccine before it receives its marketing licence. I'm no fan of this government but I agree with removing administrative blockers to getting any proven vaccine distributed as quickly as possible.

On the second point, do you have the source of this claim?

The BBC

Whitewavemark2

The point about licensing drugs is that Johnson’s government is consulting with the idea of by-passing the licensing process. It is also intending to pass legislation that will prevent an individual suing the government if she gets sick from one of these unlicensed vaccinations.

On the first point WWM2, they are only proposing to allow the use of a vaccine before it receives its marketing licence. I'm no fan of this government but I agree with removing administrative blockers to getting any proven vaccine distributed as quickly as possible.

On the second point, do you have the source of this claim?

Jane10

There you go again WWM2. It's perfectly possible to be unhappy with the elements of all political parties.

Of course it is, you speak as as if people don’t understand that.

But I am talking about the U.K. government.

If you can prove it’s competence and trustworthiness along with its incorruptibility then I will accept what you are saying.

The point about licensing drugs is that Johnson’s government is consulting with the idea of by-passing the licensing process. It is also intending to pass legislation that will prevent an individual suing the government if she gets sick from one of these unlicensed vaccinations.