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REGULATORY FRAMEWORKS
Regulatory frameworks: A balancing act?
Dr Andrew Kemp JP PhD, reader in biology, head of Scientific Advisory Group BICSc, asks if current medical device and biocides regulatory frameworks are fit for purpose, or are they impeding progress?
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 do you 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 article is written with a focus on medical devices and chemicals that are defined as biocides, that are intended for use in the medical industry. This is a very complex subject, and this article is intended to demonstrate how complex, 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. 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 technologies, they find it difficult and, in some cases, impossible to cope.
Experience shows that the EU and Australian framework models answer this problem in the first instance by trying to ‘crowbar’ it into the closest current framework, or, if they can’t do that, to simply ignore it until they can introduce another framework, which obviously takes more time and effort. The second option is to ignore it until it becomes a problem. No framework, no barriers to sale, no problem. We have seen this in other industries too with vaping and in medicines - more recently, with medicinal forms of cannabis. This one size fits all attitude raises another problem, specifically within the EU as the individual country notified bodies used by the EU to police the regulations would receive no money from registration that is coming from EU central regulators. Unfortunately, if the “simply ignore it” strategy is used, this also means that there is no way to ensure the safety or efficacy of the new technology. Regulators such as the EPA, FDA and notified bodies like the CDC in countries such as the US, China and Singapore amongst others, prefer to ask simple questions of the inventors/manufacturers: l What are the products intended use/uses? l Can they prove it is efficacious in its intended use?
l Can they prove it is safe in its intended uses? l Can they prove it is environmentally friendly in use, and when disposed of?
Ambiguity and complexity work in the favour of EU regulators. Many hours are spent in company QA/RA departments, trying to work out if they are up to date with an ever-changing myriad of regulations and bureaucracy.
OCTOBER 2019
Dr Andrew Kemp JP PhD, reader in biology, head of Scientific Advisory Group BICSc
There are varying levels of proof required for each product type, and for each intended use. These are based on risk, and the evidence 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 they are easily overcome through non- disclosure agreements.
There are obviously some pros for the EU and Australia in using the systems they have developed. This is one of the most lucrative ways for them to ‘tax’ companies without calling it a tax. The regulators charge significant fees for the process or product registration, and/or annual tariffs for licenses to continue to sell products. Fees are absolutely necessary to ensure that the regulators’ costs are covered. However, in recent years the tariffs/fees have started to get out of control as they see this as an easy target for revenue. With no way of complaining or challenging these tariffs (taxes by any other name), companies simply pay and then charge extra to the customers to recoup the costs.
Medical device, medicine, cosmetic or biocide?
Ambiguity and complexity work in the favour of EU regulators. Many hours are spent in company QA/RA departments, trying to work out if they are up to date with an ever- changing myriad of regulations and bureaucracy.
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