- With hand sanitiser gel stocks under pressure worldwide, increasing numbers of businesses are considering how they could begin direct production of their own to ensure that they have sufficient stock for their own use.
- The World Health Organisation has recently published a guide to local hand sanitiser production.
- Sanitisers are not considered medicines or medical devices from an EU regulatory perspective, but are subject to regulation within the EU as biocidal products. However, in response to COVID-19, authorities in the UK, France and Germany have recently relaxed key aspects of their local regulations in a bid to ensure that supply meets the unprecedented level of demand.
- If your business plans to manufacture its own sanitisers following the WHO Guide, using ethanol or isopropyl as the active ingredient, and gets its active ingredient from approved sources, approval may now not be needed to do so, or, where approval is still needed, the path to approval could be significantly quicker and easier than before the COVID-19 crisis.
- Given the many permutations of individual positions, advice should be sought as to your own particular situation before commencing manufacture.
- This position is as at 1 April 2020 and is subject to change as the regulatory position in relation to the COVID-19 pandemic develops.
COVID-19 and the regulation of local hand sanitiser production
With hydro-alcoholic gel (“Sanitiser”) shortages affecting businesses and individuals during the COVID-19 pandemic, authorities are prepared to relax legal controls on the production of Sanitiser and their ingredients to allow businesses to, as frictionlessly as possible, take steps to address the lack of supply. The guide to local production published by the World Health Organisation (the “WHO Guide”) has further eased this transition, providing a reference point for businesses seeking to produce their own sanitiser and suggesting two proposed formulations, based on either ethanol or isopropyl as an active ingredient.
Nevertheless, the broader pharmaceutical regulatory framework should remain a key consideration for businesses seeking to commence local production. In this OnPoint, our European life sciences practice considers the position under UK, French and German regulation in relation to the manufacture of Sanitisers, within the broader context of the response to the COVID-19 pandemic.
Requirement for authorisation
- Notwithstanding their relevance to the healthcare industry, Sanitisers are not generally considered to be medicines, or medical devices, and are instead regulated in the EU as biocidal products. As such, they fall within the regime established by Regulation (EU) 528/2012 on biocidal products ("BPR"). Under the BPR, in order to “make a product available on the market”, the active ingredient (e.g. ethanol or isopropyl) needs to be approved and the final sanitiser product itself needs to be authorised.
- The concept of “making available on the market” active substance is defined in the BPR as “any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge”.
- In Germany and the UK, BPR authorisations are not required for active ingredients which are not yet “approved” under the BPR (and were instead approved under an earlier regime) (Regulation 92 of the BPR). This includes ethanol, but does not appear to include isopropyl.
- Other requirements, such as the need to use an Article 95 BPR active substance supplier (discussed below) and labelling likely still apply (although the authorities have signalled a willingness to be flexible on this point on a case by case basis).
Requirement for an authorised supplier
- Article 95 of the BPR requires that active substances can only be obtained from an authorised supplier. However, in certain cases, relaxations on the use of an Article 95 supplier have been temporarily put in place to accelerate delivery of active ingredients.
- For example, in Germany active ingredients can be sourced from any source available due to a General Decree issued by BAuA. This is limited until the beginning of September 2020 and to the two formulations for sanitisers in the WHO Guide.
- Article 55 of the BPR provides that competent authorities (e.g. HSE in the UK and BAuA in Germany) can permit derogations from the BPR requirements if there is a danger to public health. In the exceptional circumstances surrounding the COVID-19 pandemic, we expect that derogations will be tolerated to an extent, whether formally through the Article 55 process or otherwise.
- For example, in Germany, the BAuA has issued the General Decree above based on the Article 55 process. Indeed, the ECHA (which administers the BPR) stated on 20 March 2020 that: the ECHA is “working, together with the Commission, on special arrangements to help Member States and companies get more disinfectants on the market as soon as possible.”
- In the UK, the HSE has announced special measures to speed up derogations to support increased hand sanitiser supplies.
- In France, pharmacists in towns and at hospital have been authorised by a ministerial order of 6 March 2020 to produce Sanitiser without prior authorisation, and to sell them at a maximum fixed price.
Medical devices or products
- Sanitiser will not be relevant as a medical device or medicinal product, provided that no medical claims are made about it. Businesses should therefore avoid making any claims about the sanitiser, including to their own staff, particularly related to COVID-19 and/or the effectiveness of the sanitiser in protecting against it. Any such claims may trigger the medicinal products regime established by Directive 2001/83.
- Businesses should give appropriate consideration to employee and product liability and potential tax aspects (e.g. local taxes on ethanol) that may be relevant here.
Read 'In the COVID-19 crisis, our operations in the UK, France and Germany can’t buy hand sanitiser. Can we make our own?'