Is it time for a change in attitudes towards regulatory bodies?
23 June 2020
Dr Andrew Kemp analyses the links between cleaning and cross infection, focusing on medical devices and chemicals defined as biocides.
What influences do large chemical manufacturers have over our regulatory bodies? Or What have the Romans ever done for us?
The first question we must answer is: "Are our regulatory frameworks fit for purpose?" Do they protect us from unscrupulous manufacturers or do they simply stop innovation and small companies from entering the markets, driving down prices?
It is clear that the part of the chemical industry that is responsible for disinfection enjoys the inertia from the healthcare industry that is the cause of the current status quo. It is therefore not capable of self-regulation.
It is also clear that the multiple regulatory bodies around the world are now seen as more of a “cash cow” by the governments that control them. They have become a way of raising funds through stealth taxes, rather than their original remit as the police of the chemical industry.
If the industry can’t be trusted, and the regulators are now more interested in a stealth tax on industry, who is ensuring that the public are protected?
The primary purpose of any regulatory framework, must surely be to ensure that products placed on sale in any market are fit for purpose and safe in their intended use. The problem is, how to do this effectively. How do regulators ensure that new products and new technologies can become available to the markets, without letting dangerous/harmful products through the net?
This is a very complex subject, and this article is intended to demonstrate how complex it is, and how difficult it is for companies and the regulatory bodies to achieve a balance between too much, and too little regulation.
Each country, or in the case of the EU, group of countries, has their own approach to this most difficult balancing act. Some, like the EU and Australia, prefer to use systems that are the equivalent of the children’s game, where shapes and colours have to fit into the same shaped holes.
A new product that comes from an existing product type, simply slips straight through the already used holes that previous products of a similar type used (after paying a hefty stealth tax of course). Problems begin to occur when the available frameworks are not able to adapt to new technologies. If a new product or technology is invented, the regulators in Europe try to fit it into a current framework pathway. As the pathway may not necessarily have been designed to accept any significantly different technology, they find it difficult and, in some cases, impossible to do.
Experience shows that the EU and Australian framework models answer this problem in the first instance by trying to “crowbar” the new technology into the closest current framework, or if they can’t do that, to simply temporarily ignore it. This is a successful way to deal with the problem until they can introduce a new framework that it can fit into, which obviously takes more time and effort.
The last option is to ignore it completely until it becomes a problem. No framework, no barriers to sale, no problem. We have seen this in other industries too, with vaping, medicines, and more recently with medicinal forms of cannabis. This one-size-fits all attitude raises another problem, specifically within the EU. The EU had to find a way to pay the individual country notified bodies used to police the regulations. These notified bodies receive no money from centralised registration coming from the EU central regulators (more about that later). They therefore farmed out some of the responsibilities to private companies who can charge whatever they like, and who are ultimately not responsible to anyone for any real quality at all (think VW emissions certificates).
Unfortunately, none of these strategies mean that we, the public, can be confident of the safety or efficacy of any technology currently in use - or that new technology with increased safety and efficacy will ever make it into our healthcare facilities, food manufacturing plants, or our homes.
Looking at the bigger picture
Elsewhere in the world, regulators such as the US EPA, FDA are responsible for product safety and efficacy, and notified bodies like the CDC in the US, China and Singapore (amongst others), are responsible for ensuring claims are genuine.
They prefer to ask simple questions of the inventors/ manufacturers:
- What are the products intended use/uses?
- Prove it is efficacious in its intended use
- Prove it is safe in its intended uses
- Prove it is environmentally friendly in use, and when disposed of.
There are varying levels of proof required for each product type, and for each intended use based on risk. The evidence supplied by manufacturers is given by the regulators to groups of people thought to be expert in the particular field that the product or technology comes from. This approach can cause issues over Intellectual Property and patents, but these are easily overcome through non-disclosure agreements.
Regulations from the EU can be so obscure, poorly devised, and poorly written, they become too difficult to interpret. This issue of interpretation, with a mountain of paperwork, is now becoming so profound that an entire new business model has emerged. Many people who previously worked as regulators, now work in companies that charge manufacturers to advise them which regulations apply to their products, and how to ensure they pass through the relevant regulatory frameworks.
There are even cases where a regulator has been asked for a view or advice on a particular product type, the regulator then advised the manufacturer that they should contact a private company (by name) to help them through the process! In addition, government regulators suggest that companies gain accreditation through quality systems provided by private companies. Companies such as VW have a number of ISO accreditations relevant to their industry including ISO 14001, unfortunately, it did not stop them from falsifying the exhaust emissions and fuel consumption figures. Little wonder then that many companies feel aggrieved at being herded towards using them.
We have to ask, what value do their quality systems have? Unfortunately, the answer in most cases has to be none.
In addition, by taking massive fees (tax by any other name) the regulators ensure large chemical companies are not undercut by newer, smaller companies, selling the same chemicals. By doing so it could be argued that the regulators are interfering with market competition, which naturally benefits only the very large companies who can easily afford the charges.
Clearly, acting as a protectionist office for large companies isn’t, and should never be the job of a regulator. This has nothing to do with product safety, or efficacy, and a lot to do with large companies lobbying to keep out competition. That type of protection is surely the jurisdiction of the patent office, with all individual country courts able to ensure chemicals are protected under the current patent laws.
If a chemical isn’t patented, or is out of patent, then it is not protected, and is then free to be sold on the open market by whoever can manufacture it safely.
The thankless task of policing and implementing these incomplete regulations is left to the regulators in each country. In the UK the regulatory bodies are, the MHRA for medical devices and medicines, and the HSE for both Biocides and cosmetics. Regulations pushed out by the EU, that the in-country regulatory bodies have not been consulted on before they were legislated on by the European court, are simply expected to be implemented. As you would expect the regulatory bodies are understaffed to deal with the enormity of this task, leaving them with the ability to react to complaints, and very little by way of the active seeking out of noncompliance.
You might reasonably ask: “Who benefits from this new form of “regulatory tax”, and how did it come into force?”. Clearly the EU and European Commission have benefited significantly from the “windfall taxes.” In the case of the Biocides Product Directive (BPD) changing into the Biocides Product Regulations, with more than 7000 products previously registered with the BPD, and with potentially multiple uses and fees with each chemical required to be registered, the financial benefits are easy to see.
It is also highly likely that regulators have been significantly influenced by large chemical companies lobbying the EU regulators via EU commissioners and politicians, rather than focusing on the safety and efficacy of the products they meant to be regulating. This type of lobbying was proven to change regulatory policy and regulations in the medical implants sector with disastrous results, and there have been numerous calls to regulate devices in the same way as medicines.
As the EU/ EC are not held accountable to any democratic body, and as they do not have to account for any budget, there is little that can be done to stop this in Brussels. However, lobbying behind closed doors to any UK government department, must surely be seen as a potential for coercion or corrupt persuasion, and should be banned. Pitching of ideas to government is a good idea, but this should only take place in the open, with minutes taken and then made public for proper scrutiny.
If lobbying is changing the regulations to benefit large companies, then clearly the level of the fees required to register products, is also intended to keep small to medium enterprises from registering new products stifling innovation.
Who regulates the regulators?
Is there potentially criminal negligence involved in the formation and implementation of the current regulations? Are regulators complicit with private companies as notified bodies in staggeringly incomprehensible regulations and certifications?
It is clear that regulations are required in every country in the world. In China and the USA, the regulatory frameworks primary function is to protect the population (I cannot say the same for the EU regulations), and although their regulations can be confusing, there is flexibility while maintaining 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 to small companies.
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 the approach taken by China and the USA is simple, not simplistic, and has a safety-first orientation which is not seen in the European regulations.
If this is as clear as mud to you, then you are not alone. The QA RA departments of most medical companies are having to expand at a colossal rate to keep up with the changes. Are they needed, do the regulators change the regulations to improve, or to make more money? You can be your own judge in that.
Is the situation going to improve in the short to medium term? I’m sorry to say I doubt it. There is a rumour that the UK government is investigating the potential to align the regulations more with the US and China than Europe now, time will tell. Doubtless, unless they do choose that route, the UK and the EU are likely to lag behind other countries in their chemical disinfectant options for many years to come. Protection for us all? I doubt it. Protection for large corporate chemical manufacturers? Absolutely.
How do we change this? Honestly, I don’t think we can. It will take the recognition of the coming global crisis - a crisis on a similar scale to that of global warming. Bacteria that are resistant to both disinfectants and antibiotics are on the rise, and will kill more people than cancer, heart attacks and diabetes combined if we don’t start doing something now.
At the time of completing this article, the new novel Coronavirus from Wuhan China is coming close to being declared a pandemic. This virus was not envisaged as the “coming crisis” referred to in the last paragraph. By the time it goes to print, we will have experienced the effects of this highly disinfectant resistant virus for more than six months.