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Background

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Legislative changes to The Human Medicines Regulations 2012 (HMRs) that fast-track mass vaccination using unregistered vaccines, as well as permit their advertising by commercially interested parties and their administration by non-health care professionals, should not be supported until such time that:

  1. A full range of plausible therapeutic treatments and pharmaceutical and non-pharmaceutical prevention options have been thoroughly evaluated and found to be of no significant benefit to public health
  2. Definitive results from trials (Phase III) are placed in the public domain that demonstrate COVID-19 vaccines have an acceptable risk/benefit profile to justify mass vaccination
  3. Scientific testing of possible interactions between COVID-19 and influenza vaccines has been conducted and shown to not cause any disease enhancement or other negative interaction given the two vaccines may be administered jointly.

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.

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 outside the healthcare professions, provides 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. 

Following is the response (in both full and summary forms) by the Alliance for Natural Health International to the Department of Health and Social Care’s consultation on Changes to Human Medicines Regulations to support the rollout of COVID-19 vaccines.

The deadline for responses is 18 September 2020 and responses should be made online at the following portal: https://consultations.dhsc.gov.uk/5f43b8aca0980b6fc0198f9f

Your response should be given in each of the 5 sub-sections of the consultation, namely:

  1. authorising temporary supply of an unlicensed product
  2. civil liability and immunity
  3. expanding the workforce eligible to administer vaccinations
  4. promoting vaccines
  5. making provisions for wholesale dealing of vaccine

You are free to use as much or as little of either our summary or full draft responses as you wish in your own response. We are hopeful that a large number of people resident in the UK will see fit to respond in order that the UK Government is forced to reconsider making such sweeping changes to medicines law that currently, particularly in the absence of thorough evaluation of other options for reducing the impact of COVID-19, appear not to be in the public’s best interest.

It is these proposed legislative changes that will give the UK Government carte blanche to roll-out unlicensed COVID vaccines once approval has been granted by the licensing authority, the Medicines and Healthcare products Regulatory Agency (MHRA). That could put the public at significant and, as yet, unknown risk.

We invite comments or feedback that can be emailed to [email protected] with the subject ‘UK covid vaccine consultation’ and we will take these into account when making our final submission.

SUMMARY CONSULTATION RESPONSE BY ANH Intl

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 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.

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 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.

5. 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.

 

CONSULTATION RESPONSE BY ANH Intl

1. Authorising temporary supply of an unlicensed product

General Comments

The proposed legislative changes to UK medicines law, that has since 1965 been based on that of European Economic Community (EEC) and subsequently the European Union (EU), represents the greatest change to UK medicines law in over half a century. The proposal, among other things, seeks to: 1) fast-track regulatory approval of unlicensed COVID-19 vaccines, 2) permit individuals other than qualified health care professionals to administer the vaccines so reducing the potential for properly informed consent, 3) reinstate direct-to-consumer advertising and promotion of drugs, at least for COVID-19 vaccines, and, 4) to expand the conditions under which vaccine makers or those administering vaccines are given immunity from civil liability in the event of injury.

The proposal throws to the wind 55 years of development of regulatory processes, expanded patient informed consent procedures and the mandating of more transparency from drug manufacturers.[1] These changes were adopted by the European Economic Community in 1965 as part of its medicinal code that intended to avoid any reoccurrence of disasters such as that linked to the use of the drug thalidomide by pregnant women in the late 1950s and early 1960s.

The current proposal can only be justified if six criteria are met.

Firstly, it has been adequately demonstrated that the current status of COVID-19 warrants a mass vaccination programme based on the known progression of the epidemic, including plausible estimations of the infection fatality ratio (IFR) i.e., the proportion of all those who are infected who die, and excess mortality, taking into account mortality displacement. Infection fatality rates are much more meaningful than case fatality rates (CFRs) as the latter are confounded by the amount of testing being conducted as well as by changes in methods of case assessment over time. They also do not take into account the asymptomatic or those who have recurrent infection but remain relatively healthy despite infection. Attempts to accurately determine the IFR require population-based serological studies that have yet to be prioritised by the Government. Therefore estimates of the IFR should include: a) only fatalities for which COVID-19 has been recorded on the death certificate as the primary cause of death; or b) fatalities where infection was positively determined by RT-PCR tests within 28 days of death, and; c) the extent of community-wide infection has been determined following population-based serologic studies. Even with existing data from the Office for National Statistics (ONS) and the Medical Research Council (MRC) which do not meet these criteria, the IFR in the UK at the end of July/beginning of August 2020 was estimated to be between 0.3 and 0.6%.[2] Excess deaths, while having increased significantly beyond 5-year averages during the peak of the pandemic, are currently neutral or negative for both COVID-19 involved and non-COVID-19 involved deaths.[3] There was some evidence of mortality displacement in the 4 nations of the UK from week 24, this being a short-term forward shift in mortality whereby a certain proportion of deaths (both COVID-19 related and unrelated, although potentially caused by inadequate healthcare delivery owing to the redirection of effort towards COVID-19) occurred in patients that would have died of other conditions in the following weeks or months.[4]

Secondly, it has been adequately demonstrated that the UK government, its agencies and the universities and institutions that have been funded to help reduce the impact of the COVID-19 pandemic, have exhausted all other options for therapeutic treatments or prevention approaches that could be delivered under the existing legislative framework (or at least a post-Brexit version that does not also seek to expedite roll-out of unregistered vaccines).

Thirdly, sufficient data are made publicly accessible that unequivocally demonstrate that one or more of the COVID-19 vaccines are both “safe” and “effective”.

Fourthly, that the terms “safety” and “effectiveness” as used in the second criterion (above) are qualified, following public and Parliamentary consultations. “Safety” could, for example, be defined by the relative incidence of adverse events in Phase 1, 2 and 3 clinical trials as compared with other vaccines intended for adult populations, such as those targeting influenza A(H1N1). The definition of “effectiveness”, on the other hand, should reflect the proportion (say 60%) of the vaccinated population that had been found to be immune to symptoms of disease if infected over a given period (say 12 months).  

Fifth, there is full transparency of raw data from Phase 1 to 3 clinical trials to allow independent scrutiny and evaluation. These data should be able to be evaluated entirely independently by evidence-based medical research groups, such as the Centre for Evidence-Based Medicine at the University of Oxford and the Institute for Scientific Freedom in Copenhagen.  

The sixth and final criterion is that the legislative changes are deemed necessary because the existing provisions in The Human Medicines Regulations 2012 are deemed insufficient, inadequate or not fit for purpose. Our own assessment of the current provisions do not suggest that the provisions require change, this being considered in subsequent sections of our response.

We demand that the Department of Health and Social Care (DHSC) provides comprehensive answers with respect to each of these six criteria. Conforming with these criteria would help to ensure that independent evaluation of data that typically is seen only by regulatory authorities, in the UK’s case, the MHRA, is assured. Given the revolving door that has been shown to exist between pharmaceutical companies and regulators, it is entirely inappropriate that the MHRA is given sole access and sight of manufacturers’ and trial data. Broadening of the responsibility for evaluation of data would also seek to build public confidence in the authorisation process, which would still be executed, managed and policed by the MHRA. 

Incorrect assumptions

In putting forward its proposal for radical changes to The Human Medicines Regulation 2012, the DHSC has made two assumptions that are fundamentally flawed, largely invalidating the justification for the proposed legislative changes where these specifically ease the roll-out of COVID-19 vaccines.

The Introduction opens with the statement: “COVID-19 is the biggest threat this country has faced in peacetime history.” This statement is not supported by fact. Public Health England data[5] on premature mortality (death among the under-75s) in England alone accounted for about 330 deaths per 100,000. This compares with a current risk of death of around 62 per 100,000 for deaths at any age in which COVID-19 was involved, the majority of these deaths occurring among those over the age of 75.[6] Premature deaths from cancer alone (132 per 100,000) are over twice the Covid-related mortality figure. A study evaluating the effects of socioeconomic inequality published in the Lancet showed that 36% of all premature deaths between 2003 and 2018 were caused by social inequality.[7] The Government’s response to COVID-19, whether or not it was right or wrong, will have the effect of greatly increasing socioeconomic inequality and thereby will significantly increase premature deaths in the future. The stock market reaction to COVID-19, itself a marker for future social and economic impacts, has exceeded that for any previous pandemic, including the Spanish ‘flu’ of 1918-19 and the influenza pandemics of 1957-58 and 1968. This stronger reaction was considered to be primarily the result of government restrictions on commercial activity and social distancing exerting their effect on service-orientated economies.[8] Based on the factors above, it must therefore be asserted that COVID-19 does not actually pose the biggest threat to this country in peacetime history. More than that, given the massive impacts on society and business caused by government policy in response to COVID-19, that the biggest threat this country has faced is linked to the consequences of the human (and governmental) response to COVID-19, rather than to the effects of the disease itself. It is of course not possible to estimate or predict what the consequences of a business-as-usual approach might have been on Covid-related mortality in the UK had this option been considered, but the Swedish example does suggest that severe lockdown measures do not significantly reduce total mortality, and may extend the duration of the epidemic or the risk of further infection waves.

The second paragraph of the Introduction makes another bold assumption, one that is both unsupported and, currently, unsupportable, as follows: “Effective COVID-19 vaccines will be the best way to deal with the pandemic”. UK data show that based on “deaths involving COVID-19”, 63% occurred in hospitals and 30% in care homes.[9] This is evidence of significant shortcomings in critical care and care home treatment protocols, areas in which the DHSC has failed to sufficiently invest or evaluate. This failure is predicated on the unjustified assumption that vaccines would deliver the best outcomes. This assumption was made both without any meaningful or reliable data on the effectiveness (or safety) of COVID-19 vaccines, and without due consideration for alternate treatment or prevention options. Since the UK government has avoided evaluating options against which the safety and efficacy profile of vaccines could be compared, once data become available, the Government should not be given the remit to create a legislative regime that greatly increases the exposure of the public to unregistered vaccines that, at the time the legislative changes were made, are of unknown safety or effectiveness. The Government’s failure to evaluate or develop multi-lateral protocols for use on those who are seriously or critically ill with COVID-19, including the MATH+ protocol[10] being used by critical care doctors in the USA, combined with the absence of safety and effectiveness data on COVID-19 vaccines that, in the main, rely on novel platforms involving genetically engineered antigens, dictates that the Government’s assumption that vaccines are the “best” way of dealing with the pandemic is defective. 

Legislative comments

The existing Regulation 174 of The Human Medicines Regulations 2012 already makes provision for temporary authorisation of unregistered COVID-19 vaccines by the MHRA. While the proposed new Regulation 174A provides additional conditions for temporary authorisations that will be relevant to unregistered COVID-19 vaccines, they do not go far enough if the aim is, as stated in the guidance, “to ensure product safety, quality and efficacy” with the intention of offering a high level of public protection. To do this adequately, it is necessary to add an additional condition.

This condition, that would invalidate the temporary authorisation, would be discovery of non-disclosure of relevant data or information held by manufacturers or triallists at the time the temporary authorisation was granted when such data or information relates to quality, safety or effectiveness. Such non-disclosure has been common historically.[11],[12] Given the proposed fast-tracking of the approval process, and the perceived demand for COVID-vaccines, there is a greater than ever risk that manufacturers or triallists will avoid full disclosure of relevant data. Accordingly, inclusion of such an additional provision will likely increase public confidence in vaccination.   

References

[1] Rehman W, Arfons LM, Lazarus HM. The rise, fall and subsequent triumph of thalidomide: lessons learned in drug development. Ther Adv Hematol. 2011; 2(5): 291-308.

[2] Daniel Howdon, Jason Oke, Carl Heneghan. Estimating the infection fatality ratio in England. COVID-19 Evidence Blog, 21 August 2020: https://www.cebm.net/covid-19/estimating-the-infection-fatality-ratio-in-england/#:~:text=MRC%20figures%20imply%20an%20IFR,week%20series%20on%2023%20June.

[3] Hauck K, Ferguson N. Weekly estimates of expected deaths and excess non-COVID-19 deaths during the pandemic in England and Wales. J-IDEA COVID-19 excess deaths tracker for England and Wales. https://j-idea.github.io/ONSdeaths/.

[4] EuroMOMO data for England, Wales, Scotland and Northern Ireland, Z-scores: https://www.euromomo.eu/graphs-and-maps.

[5] Public Health England source data: https://fingertips.phe.org.uk/profile/health-profiles/data#page/3/gid/1938132696/pat/6/par/E12000004/ati/102/are/E06000015/iid/40501/age/163/sex/4/cid/4/page-options/car-ao-1_ovw-do-0_eng-vo-0_eng-do-0_car-do-0.

[6] Public Health England; Mortality Profile – premature mortality: https://fingertips.phe.org.uk/profile/mortality-profile/data#page/0/page-options/ovw-do-0.

[7] Lewer D, Jayatunga W, Aldridge RW, et al. Premature mortality attributable to socioeconomic inequality in England between 2003 and 2018: an observational study [published correction appears in Lancet Public Health. 2020 Jan;5(1):e18]. Lancet Public Health. 2020; 5(1): e33-e41. https://www.thelancet.com/action/showPdf?pii=S2468-2667%2819%2930219-1

[8] Baker SR, Bloom N, Davis SJ, et al. The unprecedented stock market reaction to COVID-19. The Review of Asset Pricing Studies, 2020: raaa008.

[9] Office of National Statistics, ‘Deaths registered weekly in England and Wales….week ending 28 August 2020’: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsregisteredweeklyinenglandandwalesprovisional/weekending28august2020#deaths-registered-by-age-group.

[10] MATH+ Protocol, Eastern Virginia Medical School, VA, USA: https://www.evms.edu/media/evms_public/departments/internal_medicine/EVMS_Critical_Care_COVID-19_Protocol.pdf.

2. Civil liability and immunity

General comments

Manufacturers of vaccines in national vaccination programmes have had immunity from civil liability for over 30 years where there is no evidence of negligence or defectiveness in the vaccine or its manufacture. Where there is evidence of negligence that results in a defective product that causes injury, the injured party has recourse under the Consumer Protection Act (1987) (CPA) to sue for damages. The proposed clarification of conditions under which immunity from civil liability would be lost under proposed Regulation 174(3) is too limited and should be expanded and clarified further. We propose the addition of another condition that relates to error, omission or non-disclosure, whether deliberate or the result of negligence, that would not only better protect the public interest, it would also be likely to bolster public confidence. This condition is set out below.

Legislative comments

In terms of the proposal for inclusion or exclusion of the bracketed section that would qualify, or not, the nature of the ‘objective bystander’, the “reasonable person” who would assess the breach in the eyes of the courts, it is our resounding view that this should explicitly exclude persons “with an interest in placing medicinal products on the market” (i.e. representatives of pharmaceutical companies or other companies in the pharmaceutical supply chain). This is because such persons will have an inherent vested or conflict of interest, implying he or she would typically place his or her interest in protecting his, her or the company’s financial interests over and above the interests of the public including the public’s health.

It has been shown repeatedly that pharmaceutical companies act consistently in ways that further their own interests, these being related typically to financial gain or market control.[13],[14],[15]

Such concerns apply not only to manufacturers of conventional drugs, but also to manufacturers of vaccines.[16]

An additional condition that should constitute a breach of the temporary authorisation is given below:

Non-disclosure, omission or errors of relevant data or information relating to quality, safety or effectiveness, whether deliberate or the result of negligence, that mean that, at the time of approval, effectiveness was over-estimated and safety under-estimated, would constitute a breach in the conditions of temporary authorisation.

Such data or information, as well as the extent of the over- or under-estimates would then be able to be judged by the courts in the eyes of an objective “reasonable person” without an interest in placing medicinal products on the market.

References

[11] Doshi P, Jefferson T. Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency. Trials. 2016;17:78..

[12] Doshi P, Bourgeois F, Hong K, et al. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology [published online ahead of print, 2020 Mar 17]. BMJ Evid Based Med. 2020; bmjebm-2019-111331.

[13] House of Commons: Health Committee. The Influence of the Pharmaceutical Industry: Fourth Report of Session 2004-05. Great Britain: Parliament.

[14] Angell, M. The Truth about the Drug Companies: How They Deceive Us and What to Do about It. Random House Trade Paperbacks. ISBN: 0375760946, 9780375760945.

[15] Gøtzsche, P. Deadly Medicines and organised crime: How Big Pharma has corrupted healthcare.  2013. Radcliffe Publishing. ISBN 978‐184619‐884‐7.

3. Expanding the workforce eligible to administer vaccinations

General comments

The entire basis of informed consent is based on the premise of granting permission for a given medical intervention (in this case COVID-19 vaccination) in the knowledge of possible consequences. Informed consent is a key component of ethical medical practice and requires compliance with The Human Rights Act 1998. Particularly relevant to informed consent are: Article 2 (protection of the right to life), Article 3 (prohibition of torture and inhuman or degrading treatment or punishment), Article 5 (the right to liberty and security), Article 9 (the right to freedom of thought, conscience and religion) and Article 14 (prohibition of discrimination in the enjoyment of Convention rights).[17]

Informed consent must include the provision of information by a health care professional on the risks, benefits, advantages and disadvantages of different treatment options including not receiving treatment (in this case vaccinating).[18],[19]

Given the complexity and uncertainty of science around vaccination, it is not possible for a person who is not a qualified health care professional to provide the information required to ensure informed consent. Therefore the expansion of the workforce allowed to administer vaccinations to persons who are not authorised health care professionals (i.e., registered doctors, nurses, pharmacists or allied health care professionals) cannot be supported. The lack of provision of sufficient information that would be required to ensure properly informed consent would likely constitute a breach of The Human Rights Act 1998.

In the case Sidaway v Board of Governors of the Bethlem Royal Hospital Governors [1985] AC 871, Lord Carman stated: “A doctor who operates without the consent of his patient, save in cases of emergency or mental disability, is guilty of the civil wrong of trespass to the person; he is also guilty of the criminal offence of assault."

It therefore follows if informed consent has not been granted, a situation that is more likely to arise in the absence of relevant information on risks and benefits being furnished by a suitably trained and qualified health care professional, vaccination could be construed as a civil wrong or trespass to the person. Additionally, the vaccinator could be found guilty of the criminal offence of assault. This is presumably why the proposed amendments to The Human Medicines Regulations 2012 seek to grant to such unregistered persons immunity to civil liability.

For the reasons given above, it would be entirely inappropriate to put such individuals, who lack the duty of care associated with authorised health care professionals, in the authoritative position of administering an invasive medical procedure about which they have limited knowledge. Their lack of background, qualifications, training and oversight by a registration authority are very unlikely to give them the required capacity to understand the complex and often uncertain scientific and medical information surrounding vaccines and vaccination. Yet the person administering the vaccine is often the key individual with which a vaccine recipient interacts when providing their consent for vaccination.

Additionally, there is a likelihood that non-authorised health care professionals could be trained by commercially interested parties in ways that seek to maximise vaccination uptake to the extent that the approach taken by the vaccine administrator could readily, particularly if not adequately supervised, constitute coercion. Given that consent must include sufficient information and be voluntary, even where the person administering the intervention is a health care professional, “consent where an individual has been coerced into making the decision will not be valid.”[20]

Legislative comments

Accordingly we reject all proposed amendments (Regulations 229, 230, 231, 233 and 234) that seek to expand the workforce of vaccinators beyond the scope of authorised health care professionals, who already maintain immunity from civil liability under the terms of existing article 345(3)(d) which would include COVID-19 vaccination.

References

[16] Gøtzsche, P. Vaccines: Truth, lies and controversy. 2020. People’s Press.

[17] See Point 5, page 6, Department of Health. Reference Guide to Consent for Examination or Treatment. 2009. Second Edition. Department of Health, UK. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/138296/dh_103653__1_.pdf.

[18] General Medical Council (GMC). Seeking patients’ consent: The ethical considerations. 1998. General Medical Council, London.

[19] Sellinger C. The right to consent: Is it absolute? BJMP 2009: 2(2): 50-54.

[20] British Medical Association. Getting consent adults with capacity as a medical student: Ethics for Medical Students. Updated 1 May 2020.  https://www.bma.org.uk/advice-and-support/ethics/medical-students/ethics-toolkit-for-medical-students/adults-with-capacity-and-consent.

4. Promoting vaccines

General comments

There has been a prohibition on direct-to-consumer advertising since the passage of The Medicines (Labelling and Advertising to the Public) Regulations 1978. There is also a prohibition on advertising unlicensed medicines (for which available data on safety and efficacy is often much more limited as compared with ones that are licensed) to health care professionals. There are three key reasons why the reversal of policy that would entail casting aside the existing prohibition on drug advertising is untenable:

  1. Mass vaccination with unlicensed vaccines during a pandemic is a non-commercial activity aimed at enhancing public health and therefore should not include direct-to-consumer advertising. Advertising is defined as “the activity or profession of producing advertisements for commercial products or services”.[21] Citizens who will receive COVID-19 vaccines under the terms of Regulation 174 will not themselves be engaging with a commercially interested party, despite the fact that, as taxpayers, they indirectly pay for the vaccine. During a national mass vaccination programme utilising unlicensed vaccines with temporary authorisation, the party with which the public will primarily engage is health services administered by the Government authorities (e.g. Department of Health and Social Care, NHS, Public Health England, etc.). There will be no direct commercial relationship between commercially interested parties and the public. Therefore the amendment that proposes removal of the current prohibition on promoting unlicensed medicines to the public and health professionals could more correctly be considered a form of propaganda than advertising. Government and commercial parties will both derive greater financial benefit the greater the level of vaccine uptake so have vested interests that extend beyond the purported public health goals of mass vaccination.  
  2. Advertising typically involves the communication of claims, yet there will be great uncertainty over the claims. The amendment provides no clarification on how claims would be agreed. Presently medicinal claims are established during the extensive and time-consuming marketing authorisation process following evaluation of large quantities of data on safety, efficacy and quality. In the case of fast-tracked, unlicensed vaccines, there will be neither sufficient data nor the necessary time to adequately substantiate the accuracy of any advertising claim that might be used to enhance vaccine uptake. The Advertising Standards Authority presently acts as the advertising watchdog on behalf of the media industry, Government and the public, and there would be insufficient data available for it to be able to adjudicate in a manner that is proportionate with other sectors over the truthfulness, ambiguity or non-misleading nature of any direct or implied claims made in advertising.
  3. Advertisers are typically bound by consumer protection law, yet vaccine manufacturers and distributors would be immune to civil liability. The Consumer Protection from Unfair Trading Regulations 2008 provide wide ranging safeguards for consumers. In order to maintain a high level of protection for consumers, companies cannot mislead or harass consumers, for example “by including false or deceptive messages… leaving out important information…using aggressive sales techniques.” [22]

    Moreover, The Consumer Protection Act 1987 protects the public from products that do not reach a reasonable level of safety. If commercially interested parties are given the opportunity to advertise unlicensed products that have not undergone the same level of evaluation as licensed products, the public (consumer) may be unwittingly exposed to unsafe products.

    In both these cases, it is deeply unethical to indemnify commercially interested parties (which act as advertisers) against any civil liability. The actions of advertisers engaged with COVID-19 vaccines could quite feasibly be construed as breaches of The Human Rights Act 1998.

    Legislative comments

    We wholeheartedly reject any attempt to ease advertising restrictions on unlicensed products for the reasons given above. More than that, it is extraordinary that the spectre of the current pandemic is being used as a means of shoehorning in much wider changes that in effect will go a long way towards the ‘Americanisation’ of advertising by pharmaceutical interests.

The history of the development of DTC advertising for drugs has been complex in the USA and the current rules governing marketing were cemented in 1999. They require advertisers to include information about the risks associated with using the drug under the "adequate provision requirement" [23]. The lack of information about the safety of an unlicensed vaccine (both from trials required for licensing and post-marketing surveillance) does not allow for the adequate provision of information to citizens.

Insufficient knowledge and research on safety of novel, unlicensed vaccines imply that their administration as part of a heavily promoted (and advertised) mass vaccination programme of the public will amount to a form of experimentation on the public. This could amount to an abuse that would be in breach of ethical standards that have been in existence since the Nuremberg trials, or even earlier [24].

References

[21] Oxford English Dictionary/Lexico, definition of advertising: https://www.lexico.com/definition/advertising.

[22] Gov.UK – Marketing and advertising: the law: https://www.gov.uk/marketing-advertising-law/regulations-that-affect-advertising.

[23] FDA website: https://www.fda.gov/media/75406/download.

[24] Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ 1996; 313 :1445.

5. Making provisions for wholesale dealing of vaccine

We are generally in agreement with the proposal, given the wholesale license exemption is limited to NHS organisations, NHS contracted service providers, and the medical services of the armed forces.

In the section of the consultation response in which the DHSC asks “What could we do better?”, ANH-Intl has responded as follows:

The guideline document and the draft amendments to the HMR could have been line numbered which would have made it easier to reference particular parts of either document. We obviously don't know how you are going to handle the consultation responses but we hope you will publicly identify all individuals and organisations who responded and put all responses in the public domain to ensure transparency. We also hope that you will engage with those who have responded, including with citizen-supported non-profits like ours which represent those who have concerns about the mass vaccination with unlicensed Covid-vaccines, including potential interactions with seasonal influenza vaccines. It is essential that transparency is maintained so that citizens can interact with their elected MPs prior to the passage of the legislation in Parliament. To not do this in a transparent manner would be to deny due democratic process.

 

PLEASE FORWARD WIDELY AND REMEMBER THE DEADLINE FOR CONSULTATION RESPONSES IS 11.59 pm (BST) 18 SEPTEMBER 2020.

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