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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
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
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
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This Cov-19 consult is a framework where the *government authority* @MHRAmedicines allows temporary vaccine supply to respond to public health threat
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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'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 'ANY responsible person' or wait for it...ANOTHER pharma company! 7/11
Another pharma company (not kidding) 'in the same position' 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
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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's it folks, hope that helps. Very interested in hearing your thoughts on any of the above
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That's it folks, hope that helps. Very interested in hearing your thoughts on any of the above
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