I’m sure many of you recently had the same experience I had. I went to the pharmacy in the early days of the pandemic and, before I opened my mouth, the pharmacist said “we’re out of masks and hydro-alcoholic gel”. I had a prescription for allergy medicine, which I was fortunately able to get filled.
Indeed, pharmacies and stores across the world have been raided and it has been quite difficult to buy hand sanitisers for some time now. So what causes this shortage? It should be relatively easy to produce these hydro-alcoholic gels and flood the market.
Of course there is the physical production process and the difficulties to secure enough raw material. But alcohol is a rather common product. Many of you may have seen the news of vodka producers donating distilled alcohol to producers of disinfectants.
A necessary long authorisation process
Hand sanitisers and surface disinfectants are regulated products in many OECD countries. Companies that want to sell disinfectants are required to obtain an authorisation for each product. For example, in the EU, all disinfectants are regulated under the Biocidal Products Regulation and in the US, surface disinfectants are regulated under the Federal Insecticide, Fungicide and Rodenticide Act, whereas hand sanitisers are regulated as non-prescription drugs. The objective of all these regulations is that these products are not only safe for the consumer to use, but also actually work and do what they claim on the label.
But applying for an authorisation involves extensive testing and can become very costly, especially with respect to safety issues. The average testing cost to generate the data package required for a new biocidal [1] active substance is around EUR 5 million. This may sound high, but without these types of regulations and their subsequent enforcement, things can easily go wrong.
For example, between 1994 and 2011, disinfectants for air humidifiers were sold in Korea. These products were meant to reduce microbial growth in the water used by the air humidifiers and hence reduce the microbial load of the water vapor produced, thereby protecting the consumers’ health. But it turned out that the active ingredient in the disinfectants was insufficiently tested for safety and ended up killing more than 100 people and injured many hundreds more. Korea has since significantly improved its legislation regulating such products.
While disinfectants can be harmful to health or the environment when they are toxic, they must be effective at killing pathogens that pose a risk to human health. Their use can also have dramatic consequences if they lack efficacy. Imagine what could happen if a disinfectant used in hospitals had not been tested correctly for its efficacy!
Of course, once the active ingredients in disinfectants are approved, getting authorisation for products containing them is much cheaper. Luckily, many of the active ingredients needed to produce disinfectants and hand sanitisers that are effective against viruses are already approved. For example, the active ingredients of the hand sanitiser formulations recommended by the World Health Organisation, ethanol and isopropanol, are authorised for those purposes in most countries.
Emergency procedures in a time of crisis
To cope with the increased number of requests for authorisations of additional disinfectant products during the COVID-19 crisis, several countries have triggered emergency procedures to speed up the process. For example the EU has launched an emergency procedure for producers who need to get approval to use alternative providers of active substances, or producers who wish to put products with new active substances on the market.
The US Environment Protection Agency (EPA) has put similar measures in place for surface disinfectants, and the US Food and Drug Agency has done so for hand sanitisers.
These emergency procedures have been effective and the list of approved products is growing daily.
What’s next and what is the role of international collaboration?
Lessons learned: Countries with legislation in place for the emergency authorisation of disinfectants and other types of biocides will take stock after the COVID-19 crisis and evaluate how well the legal framework coped with the crisis. They may adjust their legislation accordingly. Exchanging these “lessons learned” between countries will be crucial to elaborating best practices and giving advice to countries that are in the process of setting up similar legal frameworks.
Further harmonisation between countries: Global chemical companies seek to market their chemicals in multiple countries at the same time. Hence, the more similar the process and requirements are in all countries, the quicker new compounds can be assessed for their efficacy and safety and brought to the international market. A lot has been achieved regarding the harmonisation of safety testing through the OECD Test Guidelines for the safety testing of chemicals. But more could be done.
- For example, while there are OECD guidelines on testing the efficacy of disinfectants used on hard surfaces, more collaborative efforts are needed to extend this to other types of uses. Furthermore, consumers want to know whether a product is effective for a particular type of bacteria or virus like the one responsible for COVID-19, making it necessary to further develop existing methods to improve efficacy for specific types of contaminants.
- In a second example, there is an OECD-wide system in place for countries to accept each other’s safety test results. However, there is no similar system where countries accept each other’s authorisations for disinfectants or other biocides. Nevertheless, work has started to facilitate the exchange between countries of parts of their review of the authorisation dossiers. This practice of exchanging the results of their review should be expanded to all parts of the dossiers (including both safety and efficacy aspects) in order to increase trust in each other’s authorisation decisions.
In summary, the current COVID-19 crisis shows that increased international collaboration to globally ensure the safety and efficacy of disinfectants and and other biocides is more urgent than ever. The OECD Biocides Programme provides the forum and opportunity for such cooperation.
Browse the latest OECD contributions to the global effort to tackle coronavirus (COVID-19): www.oecd.org/coronavirus
[1] Biocidal products represent a wide range of products e.g. disinfectants, wood preservatives, rodenticides, anti-fouling agents (on boats), in-can preservatives, used in homes, public places such as hospitals, and industries, to destroy and control viruses, bacteria, algae, molds, insects, mice or rats. They help inter alias prevent the spread of diseases and food poisoning.
