The following is my submission to the UK gov consultation detailed here.  I submitted comments for the three sections whose headings are underlined/bolded below. The full title of the consultation is 'Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines.

Temporary authorisation of the supply of unlicensed products

 

The unsupported/undisclosed premise which these proposed changes are based upon is that a COVID-19 vaccination is urgently and desperately required. However, such is certainly not the case as the 102 collected studies (60 of which are peer reviewed) listed at https://c19study.com/ on the use of hydroxychloroquine/chloroquine for treating COVID-19 conclusively evidence. Statistically combined, the studies show an efficacy rate for successful treatment of between 63-100% (average 75%).

 

Further a deeper analysis of the studies provided at: https://hcqtrial.com/ concludes:

 

"Many countries either adopted or declined early treatment with HCQ, effectively forming a large trial with 1.8 billion people in the treatment group and 663 million in the control group. As of September 17, 2020, an average of 67.0 per million in the treatment group have died, and 474.1 per million in the control group, relative risk 0.141. After adjustments, treatment and control deaths become 140.2 per million and 709.2 per million, relative risk 0.20. The probability of an equal or lower relative risk occurring from random group assignments is 0.014. Accounting for predicted changes in spread, we estimate a relative risk of 0.26. The treatment group has a 74.5% lower death rate. Confounding factors affect this estimate. We examined diabetes, obesity, hypertension, life expectancy, population density, urbanization, testing level, and intervention level, which do not account for the effect observed."

 

Therefore, there is no rationale or basis for a temporary authorisation of the supply of unlicensed products. Such a temporary authorisation should only be considered when there is actually no viable alternative -- and not when the perfectly reasonable, proven and safe viable alternative is being purposefully sidelined/negated by vested interests.

 

As above, hydroxychloroquine/chloroquine is a study proven treatment for COVID-19 and also a medication deemed safe after wide-scale use over many decades. In contrast, a temporary authorisation of the supply of unlicensed products will open millions of UK individuals to the risk of serious injury caused by what necessarily will be (time wise) an inadequately extended time-tested vaccine.

 

Civil liability and immunity

 

As regards the sections:

 

"The challenge is whether, in this particular context, it would be better if the ‘objective bystander’ was someone with specialist knowledge of the subject matter in hand – ideally both technical understanding and experience of what may be very difficult issues."

 

"If we do go with the additional words in square brackets, the specialist bystander would however need to be a ‘reasonable’ pharmaceutical company. That again is an objective test. However, the advantage of a ‘reasonable’ pharmaceutical company in this context is that they can indeed be expected to have detailed knowledge about every aspect of the supply chain from manufacture to final supply."

 

"Alternatively, it would be possible to have as the ‘objective bystander’ any reasonable person – the man or woman in the street."

 

Unless the underlying aim really is to deliver pharmaceutical companies and vaccine proponents 'everything on a silver platter', then it is only reasonable that the objective bystander (perspective) be considered as the man or woman in the street. COVID-19 is a highly propagandized ongoing current event with potentially trillions of pounds of business at stake. It is therefore not reasonable to suppose any person’s perspective in the pay of a so-called ‘reasonable’ pharmaceutical company would hold a viewpoint which is unbiased and just. And just so it is covered, I include industry experts in the same category as a ‘reasonable’ pharmaceutical company, given they are ultimately usually 'rewarded' by the same vested interests.

 

I consider my perspective representative of 'the man or woman in the street' in the sense that I am not beholden to any industry lobby and am most interested and guided by what correctly run studies show about various relevant factors to do with COVID-19. Therefore it is only right that the perspective of 'the man or woman in the street' is also provided for in the legislation, so as to ensure counterbalance to the other extremely powerful and moneyed interests.

 

Expansion to the workforce eligible to administer vaccinations

 

The changes proposed will mean that individuals of far lesser competency and experience (when it comes to medical dealings) will be permitted to inject/vaccinate members of the public.

 

In general existing medical practitioners are of an extremely professional mindset, and they have much to lose by not conducting themselves in such a manner (given what they have invested in training and their career, etc). In no way can it be expected that 'an army' of pseudo-medical practitioners will conduct themselves to such a high standard after a short training course.

 

My main concerns with such pseudo-medical practitioners are related to potential coercion and a lack of respect for an individual's rights. Namely that in the current societal climate:

 

• a) Such pseudo-medical practitioners might coerce and force individuals to be vaccinated.
• b) Such pseudo-medical practitioners might not respect an individual's right to read and familiarise themselves with the vaccine paperwork/insert (which in effect is part of a contract) so as to then enable them to make an informed decision based on their reading of it [the insert].
• c) Such pseudo-medical practitioners may represent the vaccination as compulsory/mandatory and thus mislead individuals.

It would be naive not to take into account the current highly charged cultural feelings and beliefs about COVID-19 much of which is not justified as regards what science demonstrates about the actual risk it poses (at least in the under 75s without comorbidities).