We've been overwhelmed by the reach and response to our video from last week drawing attention to the UK government consultation on proposed changes to UK medicines law intended to help the rollout of Covid vaccines. 

This week, we want to remind you the deadline is this Friday, 11.59pm BST. 

We ask that you engage with the consultation, and that you share your views with your MP and your friends, family and social networks. 

Our draft comments in summary and long-form are on last week's article. You'll find guidance on writing to your MP following the video call to action from our founder and executive director below. 

The Department of Health & Social Care has added a new Welcome note for those planning to submit a consultation response. It's designed to put you off if you don't like the changes the UK Government proposes. It specifies 4 things the consultation doesn't relate to, including mandatory vaccination, fast-tracking regulatory assessment, administration of untested unlicensed medicines and powers for vaccine administration by untrained personnel.  

Fortunately, none of these are relevant to the issues we raised in our draft response that we know has already formed the basis of a large number of responses. So - please don't be put off - just follow our guidance if these issues resonate with you. Thank you for making a difference.  

Guidance for your letter to your MP

Please note that it is much better if you can personalise your letter or email as it has a significantly higher chance of being read and taken seriously than a form letter/email received in large numbers. MPs want to hear what’s affecting their constituents and what they can do to make a difference, especially if it’s going to increase their popularity in their constituency! They usually have an assistant who processes mail for them, so the time you spend personalising your letter can make all the difference in ensuring your MP actually sees it and takes action.

Find your MP and his/her contact details here.

                                                      >>Your address
                                                           and postcode>>

>>Date>>

>>Rt Hon XXXXXXX
Their address>>

Dear Mr/Mrs/Ms >>surname>>

Re: Proposed Legislative changes to The Human Medicines Regulations 2012

I’m writing to you today to express my deep concern about the changes that the Government is proposing to make to the Human Medicines Regulations (HMRs), as set out in the Department of Health and Social Care’s consultation on ‘Changes to Human Medicines Regulations to support the rollout of COVID-19 vaccines’ that closes this Friday, 18 September 2020.

I’m extremely perturbed that the proposed amendments to the HMRs undo over half a century of regulatory development in the fields of medicinal and consumer protection law that had the intent of protecting the interests of citizens. I feel so strongly about these changes that I have submitted my own comments to the consultation. However, as a Member of Parliament >>or the Cabinet if they hold a ministerial post>> I am asking you to please ensure time for adequate debate when this makes its passage through Parliament (expected October 2020) and to not just rubber-stamp the changes.

I have every faith that you and your staff will have already recognised the importance of this consultation and I hope that you will, on behalf of your constituents, make much in Parliament of the expansion of legal immunity to civil liability, coupled with a reversal of the prohibition of direct-to-consumer advertising and the expansion of the workforce of vaccine administrators to people who are not legally authorised health care professionals. One of my concerns – and I know there are many who feel similarly – is that this could provide a recipe for coercion and a disregard for informed consent. This would create an environment where the planned mass vaccination programme of the British public using novel, unlicensed COVID-19 vaccines could constitute serious breaches of The Human Rights Act 1998.

I summarise the main thrust of my consultation response below:

1. 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.

2. 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.

3. 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 Sidaway 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.

4. 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 techniques 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.

Please respond to my letter and outline the steps you intend to take to address my concerns.

I look forward to hearing your response in due course.

Yours sincerely,

<<Your name>>