Konsultacje społeczne w sprawie przymusowym szczepieniom w UK.
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UK law changes for COVID-19 mass vaccination – time is running out
It has come to our attention that the government portal link previously sent out can throw an error which makes it look like you have completed the survey. If you get such an error, make sure you clear your computer cache and copy and paste the link again – please see below.
Have your say on changes to UK medicines law planned to herald the greatest vaccination programme in British history.
The deadline for responses is 11:59pm on Friday 18 September 2020 .
Responses should be made online at the following portal:
Please be aware that this government portal link can throw an error which makes it look like you have completed the survey. If you get such an error, make sure you clear your computer cache and then copy and paste the above link into your browser again.
Below are the answers that you can copy and paste in the relevant sections of the above government survey:
- Authorising temporary supply of an unlicensed product
- There are no trial data as yet that confirm the risk/benefit profile of candidate vaccines, therefore it is premature to change to change existing provisions under Regulation 174 of the Human Medicines Regulations (HMRs)
- The UK Govt has yet to adequately evaluate other options for therapeutic treatments and prevention approaches that could be delivered under the existing legislative framework. The terms ‘safety’ and ‘effectiveness’ need to be qualified
- Full transparency of raw data from phase 1 to 3 clinical trials to allow independent assessment
- Any revisions to Regulation 174 should include a new condition in which evidence of non-disclosure of relevant data or information by manufacturers or triallists relating to quality, safety or effectiveness would represent a breach of the temporary authorisation of the unregistered vaccine.
- Civil liability and immunity
- The existing provisions under Regulation 174(3) are too limited and should be clarified further
- The “reasonable person” should exclude persons “with an interest in placing products on the market”
- This is owing to inherent conflicts of interest which would reduce the likelihood of an ‘objective bystander’ view that is in the public interest
- Non-disclosure, omission or errors of relevant data or information relating to quality, safety or effectiveness, whether deliberate or the result of negligence would constitute a breach in the conditions of temporary authorisation.
- Expanding the workforce eligible to administer vaccinations
- Administrators of vaccines are typically key providers of information required to ensure informed consent
- Individuals who are not authorised health care professionals have no accountability, nor is there oversight in terms of their expertise in the complex and uncertain field of vaccine science
- The Sideaway 1985 case [AC871] set the precedent for doctors who operated without consent of patients being guilty of the civil wrong of trespass to the person and the criminal offence of assault
- Providing immunity from civil liability to non-health care professionals would create scenarios in which individuals were readily deprived of fundamental human rights through lack of informed consent (The Human Rights Act 1998, Articles 2, 3, 5, 9, 14)
- Accordingly, proposed amendments to Regulations 229, 230, 231, 233 and 234 that seek to expand the workforce of vaccinators beyond authorised health care professionals are rejected.
- Promoting vaccines
- Reversing the prohibition on direct-to-consumer (DTC) advertising of unlicensed medicines and vaccines would be a backwards step
- Mass vaccination with unlicensed vaccines during a pandemic is non-commercial activity and therefore should not include advertising
- Advertising involves communication of claims, yet given the experimental nature of vaccines there is great uncertainty over claims
- It would be wrong to provide immunity to civil liability to vaccine manufacturers allowing them to escape consumer protection laws that bind other advertisers
- Advertising could include deceptive messages, omission of important information and the use of aggressive sales technics which would otherwise constitute breaches of the Consumer Protection from Unfair Trading Regulations 2008
- It would be ethically wrong to use the pandemic to shoehorn in much wider changes that would in effect ‘Americanise’ advertising by pharmaceutical interests.
- Making provisions for wholesale dealing of vaccine
- It is acceptable to limit wholesale license exemption to NHS organisations, NHS contracted service providers, and the medical services of the armed forces.
The College of Naturopathic Medicine
Tel: 01342 410505 Fax: 01342 410909