REGULATORY FRAMEWORKS


This then means that products identical to those already on the market, that could be sold more cheaply, are being kept out of the EU markets. In fact, the UK is one of the cheapest countries in the world to manufacture chemicals, therefore, the higher prices being paid by organisations such as the NHS, must include significant profit margins for the larger companies. This is a massive win for large chemical companies, basic commodity type products remain at a higher price than if free market forces were allowed to dominate.


This, in some ways, is similar to the


OPEC cartel that ensures production and demand for oil, keeps the oil prices high - making more profit than if the markets were to be free. To be clear, this has nothing to do with quality, safety or efficacy, and in the end, of course, it is the customer who always pays. I am sure that the EU and the individual country governments are not in the least bit concerned about that, given the revenues they receive from this system.


Regulating the regulators


Who then regulates the regulators, and is there potentially criminal negligence involved in the formation and implementation of the current regulations? Are regulators complicit with private companies in producing staggeringly incomprehensible regulations and certifications?


It is clear that regulations are required in


every country in the world (although there are no regulations in Hong Kong at present). In China and the USA the regulatory framework’s primary function is to protect the population and, although the regulations can be confusing, there is a clear distinction of what product type comes under which regulatory framework. If a product type is already registered, then the process of registration is simplified, and costs reduced massively. It is also clear what is required in regard to proof of product safety and efficacy, and although it can be time consuming, the fees for the process of registration are not


prohibitive. It can take several months to get a product that is already known through, and more than a year for a new technology. However, it is clear that this approach is simple, not simplistic, and has a safety-first orientation which is not seen in the European regulations. Perhaps it is disingenuous to suggest that there has been legalised foul play involved in Europe. If the true motivations for regulatory change are financial - and not safety - first, we may never get an answer to that question. Will we ever see an investigative journalist, or a law firm that specialises in forensic legal analysis, test a claim of criminal negligence against a regulatory body in a court of law? Perhaps we will, but only after an event that causes a significant number of people to be harmed, through the non-introduction of a technology, due to regulatory frameworks - and then only if it could be proven that the new technology would have prevented the harm from occurring. The complexity and difficulty of proving that anything would have been prevented from occurring by an action or inaction, especially in a court of law, is almost impossible to imagine.


The EU and EC own rules and contracts ensure that no individual while working for the EU can be held criminally negligent for the work they have done, regardless of the outcome. It would have to be the EU and EC as institutions that are held to account through the European court of justice, which as this is also controlled by the EU and the EC, will, of course, mean that it never happens.


Conclusion


If you remain unconvinced about how we are being let down by regulatory frameworks, it is easily seen with the recent growth in the use of cannabinoids in medicine. The base chemical THC, combined with CBD, are now used and prescribed in several countries by doctors for alleviation of a number of medical conditions from pain, to anxiety. In the UK and Europe CBD is still


regulated as a “food supplement” which means it is not even regulated to the same extent as a drug such as paracetamol. Recent testing of CBD products on sale to UK customers showed not only did some also contain THC in varying amounts, but in some cases no CBD at all.14


There is,


therefore, a question over whether some of the CBD oils would cause people to fail drug tests. How can this be allowed to happen on the one hand, when perfectly safe chemical disinfectants are not being allowed into the market on the other? As a world community, we rely on regulations, regulators and notified bodies, to ensure that the products are efficacious and safe in use. When there is potential for corruption of the regulations based on financial gain for either large companies or the government/EU coffers, we can no longer rely on the regulators, to produce regulations that notified bodies can enforce keep us safe. How can we be sure that they ensure we have the best technologies available for the needs of our healthcare facilities? In some countries and country groups, including the EU and therefore in the UK, they are clearly no longer fit for purpose, and could in fact be unintentionally harming the very populations they are supposed to protect and serve. CSJ


References


1 Biocides Product Directive – BPD 98/8/EC 2 Biocides Product Regulations – BPR EU 528/2012 3 Medical Devices Directive – MDD 93/42/EEC 4 Yoshino N et al – Synthesis of Antimicrobial Activity of Quaternary Ammonium Silane Coupling Agents. Journal of Oleo Science 60, (8) 429-438 2011.


5 Ioannou CJ et al – Action of Disinfectant Quaternary Ammonium Compounds against SA


6 www.ncbi.nlm.nih.gov 7 Denyer SP, Stewart GSAB – Mechanisms of action of Disinfectants. International Biodeterioration & Biodegradation 41, 261-268 1998


8 Bowers S, Cohen D – How lobbying blocked European safety checks for dangerous implants. British Medical Journal (8178) 348-352 1st Dec 2018


9 Godlee F (Editor in Chief BMJ) - Why aren’t devices regulated like drugs? (8178) 335 1st Dec 2018.


10 Wright GD – Bacterial resistance to antibiotics: enzymatic degradation and modification. Adv Drug Deliv Rev 57, (10) 1451-70 2005


11 Russel AD – Bacterial Resistance to disinfectants: present knowledge and future problems. J Hosp Infect 43, Suppl S 57-68 1999


12 Goodchild L – Disinfectants can make bacteria resistant to treatment. Science news, Microbiology Society. Public release 5th Oct 2008


13 Kemp A – Prevention, is it now the only cure? Clinical Services Journal, Infection Prevention issue Dec 2018.


14 Kemp A, Diggle M – How do we clean up this mess? – A review of the testing methodologies used for detection of live bacteria in healthcare environments. American Journal of Biomedical Science and Research. ISSN 2642-1747 P244-248 August 2019.


15 S Christiansen - Will CBD oil result in a positive drug test? Holistic Health, July 2019


20 I WWW.CLINICALSERVICESJOURNAL.COM OCTOBER 2019


©Robert Przybysz - Fotolia


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