CONSULTATION ON VACCINE ROLL-OUT: CALL TO ACTION
This consultation has just been launched, and we only have until 18th September to respond, via this survey consultations.dhsc.gov.uk/5f43b8aca0980b6fc0198f9f?fbclid=IwAR2l0heUZE7j0wknFftX1ckIe1RurcoZVvk0OFs1GduOHl60qSgtBerdxi0
Very important that as many people as possible respond.
I've read through quickly and have listed some of the main points of the consultation, with a few suggestions for arguments to make in response, to kick off a discussion. Please comment with further suggestions.
To summarise:
1) The Human Medicine Regulations already give the government the legal right to authorise an unlicensed COVID-19 vaccine. If a vaccine was available before the end of the transition period, but hadn't been licensed by the European Medicines Agency, it could be rolled out unlicensed BEFORE THE END OF 2020.
2) There is already reduced liability for manufacturers of unlicensed medicines:
"The current legal framework already recognises that if manufacturers or healthcare professionals are asked to supply an unlicensed medicine in response to a public health threat, it is unfair also to ask them to take responsibility for the consequences of the use of that medicine in the way that they normally would."
3) The government is proposing to "clarify" the legislation by extending this exemption from liability to pharmaceutical companies placing unlicensed products (ie vaccines) on the market, to give them the "assurance that they will not be exposed inappropriately to civil liability."
4) There is provision within the regulations to remove immunity for civil liability for "serious breaches" of conditions. The government is suggesting that there should be an "objective test" of whether the breach is serious enough for immunity to be removed. They are considering whether the "objective bystander" should be another pharmaceutical company (I kid you not ?) or "the man or woman in the street".
5) There will be an enormous expansion in the workforce legally allowed to administer vaccines, to include "midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists."
6) The government is proposing a relaxation of rules to allow advertising of unlicensed products, including the Covid-19 vaccine, and to allow promotion through national campaigns.
Ideas for inclusion in response:
1) Authorising an unlicensed vaccine could be detrimental to safety, and could potentially cause injury and death. This is a very dangerous proposal, and should be rejected.
2) The suggestion that the vaccine could possibly be rolled out before the end of the transition period has very worrying implications for safety. Vaccines normally take 8-10 years to develop.
3) Given the reduced time frame for safety testing, there should be no exemptions for liability. If pharmaceutical companies are encouraged to prioritise speed of development over safety, and are exempted from any liability if things go wrong, there could be disastrous consequences. The fast-tracked H1N1 vaccine caused serious lifelong side effects, including narcolepsy, to a significant number of people.
4) Given the history of bribery and corruption within the industry, pharmaceutical companies should not be designated "objective bystanders", in considering whether there has been a breach serious enough to remove immunity for civil liability. This should be the role of the "man or woman in the street", in keeping with the legal traditions of the UK.
5) Any advertising of the vaccine should carry a clear health warning that it has been fast-tracked and therefore not all the usual safety tests have been carried out. It should also state that it is unlicensed (if this proposal is adopted).
6) There will clearly be risks to taking this vaccine, so it should not be made mandatory, nor should access to the workplace or any other aspect of society be made conditional on taking it. Where there is risk, there must be choice. Forced medical procedures may be routine in totalitarian dictatorships, banana republics and police states, but they have no place in a democracy or any civilised society.
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?fbclid=IwAR1xQRP53_SMIfKMrUenLYDbgwJvoE2PYY8laU6BDvfXIbqScyPdP8PAqSQ#responding-to-this-consultation
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