Response to Consultation document: Human Medicine Regulations

Introduction

Evidence has shown that Covid-19 is far from being “the biggest threat this country has faced in peacetime history”, although the statement may well be true of the government’s draconian, disproportionate and often illogical responses to it. Many highly-qualified experts in medical and scientific fields would dispute the assertion that the government “is working to a scientifically led, step-by-step action plan for tackling the pandemic”, particularly as the government’s handling of the disease remains based upon comprehensively discredited modelled outcomes produced by Prof. Neil Ferguson et al. Indeed, actual data shows that the pandemic has in fact ended as far as the UK and many other countries are concerned and that the “second wave” being threatened by the Minster for Health is extremely unlikely to happen^¹. The SARS-CoV2 virus has behaved similarly to other virus outbreaks and the patterns of spread and decline have been perfectly normal, with the overall outcome being on a par with a bad influenza season. One key difference though is that unlike influenza, SARS-CoV2 rarely causes serious illness to younger people without pre-existing health issues and should actually be easier to manage since vulnerable groups are more easily identified.

Given the above, it is evident that there is no current public health emergency due to SARS-CoV2, nor is there likely to be one in the near future. Any proposed changes to the Human Medicine Regulations should be viewed in this light.

Comments on specific proposals are set out below.

1. Temporary authorisation of the supply of unlicensed products

It is recognised that any vaccine (or other medicine) authorised for use should be both safe and effective; I would add a further requirement, which is that administration of any such medicine should also be necessary.

The high level of focus upon development of a vaccine for SARS-CoV2 and its perceived urgency creates a situation in which safety is likely to be compromised. Time and commercial pressures may lead to shortcuts in development, noting that typically a new vaccine would take 15 – 20 years to develop and license. In the drive to produce a marketable product, testing is likely to be compromised; there is a high probability of confirmation bias when reviewing results which may lead to the introduction of a product which is not as safe as it should be. Similar risks arise in determining the effectiveness of a proposed vaccine.

A further threat arises due to the government having made development and deployment of a vaccine the key to removal of constraints upon life and a return to some form of “normal”. This may lead to the standards of safety and effectiveness required to be demonstrated by the supplier of any potential vaccine against SARS-CoV2 being set lower than would normally be the case, simply in order to make quick procurement and use of a vaccine possible.

The risks are exacerbated by the fact that some of the potential vaccines under development make use of novel technologies which are unlike anything that has been used before, and therefore the longer term effects cannot be estimated or predicted in any meaningful or rational way. This potentially poses a major threat to the health of the public which could far exceed the impact of the SARS-CoV2 virus. Nobody can say that such a vaccine would be safe since there are no data on such products; any assessment of safety would thus be pure guesswork.

As noted, there is no current public health emergency due to the presence of SARS-CoV2 in the general population and treatments are available for such cases as may occur. There is therefore no necessity for the urgent deployment of a vaccine for the virus and in view of this and the risks to safety highlighted above there is no justification for authorising the use of an unlicensed vaccine.

2. Civil liability and immunity

Protection of vaccine developers, manufacturers and suppliers from civil liability exacerbates the risk of unsafe products being supplied and administered to the public, since there is no financial or other impact (except perhaps loss of sales in the longer term) to those organisations. Such liability must therefore fall to the government, creating an unquantifiable but potentially huge contingent liability. Given the lack of need for urgent vaccination of the public and the massive financial liabilities already incurred by the government through its response to SARS-CoV2, it is difficult to see any justification for creating this further liability.

In relation to Regulation 345(4) there is another risk, in that the definition of “defective” in the application of Part 1 of the Consumer Protection Act may be decided by the government in such a way as to protect the supplier from a liability which should properly fall to it.

For circumstances in which protection from liability may be lost, the consultation document seeks views upon who should perform the role of “objective bystander”. This ought not to be a person or organisation with vested interest in the subject, such as another pharmaceutical company (as suggested), but an independent organisation with relevant expertise, perhaps such as the Defence Science and Technology Laboratory.

3. Proposed expansion to the workforce eligible to administer vaccinations

No comments.

4. Vaccine promotion

The concept of advertising or otherwise promoting an unlicensed vaccine (or other medicine) raises questions of ethics since it is likely to give rise to a mistaken perception that the product is fully approved for use (i.e. licensed) and therefore safe. If advertisement or promotion were to be permitted then every such instance ought to carry a warning to the effect that the product has not been licensed and may therefore carry risks, and explain why it is being offered for use. That should at least cause potential recipients to consider carefully whether or not to accept the product and its associated risks.

5. Make provisions for wholesale dealing of vaccines

No comments.

Conclusion

Available scientific evidence shows that there is no current health emergency due to SARS-CoV2 and that there is thus no need to rush to deliver a vaccine, if indeed it proves possible to develop one since no-one has previously produced a successful vaccine against a coronavirus. Rushed development creates safety risks which in the case of novel vaccine technologies are incalculable. The primary objective must be to protect the health of the public, consistent with enabling normal life; this would best be achieved through the concept of “herd immunity”, which has been successfully demonstrated by Sweden.

1 “How likely is a second wave?” Paul Kirkham, Professor of cell Biology and Head of Respiratory Disease Research Group at Wolverhampton University; Dr Mike Yeadon, former CSO and VP, Allergy and Respiratory Research Head with Pfizer Global R&D and co-Founder of Ziarco Pharma Ltd; Barry Thomas, Epidemiologist