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What powers does this consult on Covid-19 vaccine propose that are new to existing legislation such as Early Acess to Medicines (EAMs) program?
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@MissChisomo #pharmacovigilance https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines">https://www.gov.uk/governmen...
Thread 1/11
@MissChisomo #pharmacovigilance https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines">https://www.gov.uk/governmen...
Firstly, this Cov-19 consultation does not cover which groups should receive or be prioritised for a Covid-19 vaccine
Cont 2/11
Cont 2/11
The big difference to existing legislation: EAMs scheme is a framework for *companies* to seek scientific opinion.
This Cov-19 consult is a framework where the *government authority* @MHRAmedicines allows temporary vaccine supply to respond to public health threat
3/11
This Cov-19 consult is a framework where the *government authority* @MHRAmedicines allows temporary vaccine supply to respond to public health threat
3/11
What is proposed in gov. led scheme?
1. Gives MHRA temporary auth powers for unlicensed Covid treatments
2. Provides immunity from civil liability to MHRA*
3. Proposes non-HCP vaccine givers
4. Allows promotion of unlicensed vaccine
5. Wholesaler dealer licences exemptions 4/11
1. Gives MHRA temporary auth powers for unlicensed Covid treatments
2. Provides immunity from civil liability to MHRA*
3. Proposes non-HCP vaccine givers
4. Allows promotion of unlicensed vaccine
5. Wholesaler dealer licences exemptions 4/11
Let& #39;s go directly to 2. Liability
Currently companies & manufacturers are protected from being sued for treatments to prevent the spread of a pathogen. This consult proposes the gov authority MHRA is also protected. And then the interesting bit...! 5/11
Currently companies & manufacturers are protected from being sued for treatments to prevent the spread of a pathogen. This consult proposes the gov authority MHRA is also protected. And then the interesting bit...! 5/11
Liability protection only covers when made to specifications. The consult states that technical deviations can occur "with inconsequential effects". And so someone needs to decide if there has been a serious breach. You might think that would be the **regulator** then... 6/11
No, the regulator is not mentioned even though they uphold Good Mamufacturing Practice & have GMP inspectors. Instead a *3rd party objective bystander* is proposed. Either & #39;ANY responsible person& #39; or wait for it...ANOTHER pharma company! 7/11
Another pharma company (not kidding) & #39;in the same position& #39; as the comp with the treatment can be the objective bystander. Wow. What could possibly go wrong? One company deciding the fate of a competitor or worse. And what is role of regulator here? Makes no sense 8/11
3. Proposal to allow non-healthcare professionals to give vaccines eg in Occupational Health schemes. Also midwives, nursing associates, physiotherapists, operating theatre practitioners
9/11
9/11
4. Allows promotion of unlicensed vaccine which is currently prohibited, in minister approved campaigns. Also allows companies to participate in public / HCP campaign
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5. And finally exemptions on wholesaler dealer licences for NHS orgs, contracted service providers & armed forces.
That& #39;s it folks, hope that helps. Very interested in hearing your thoughts on any of the above
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That& #39;s it folks, hope that helps. Very interested in hearing your thoughts on any of the above
11/11
