To assist those producing vital equipment such as ventilators, personal protective equipment (PPE) and hand sanitiser, the government has relaxed the regulatory regime governing specific products. Nevertheless, it is important that businesses seeking to diversify still ensure they are taking account of the regulatory framework for any new products.
We consider below some of the key medical products that are required to combat the spread of coronavirus and the important regulatory considerations for each.
Hand sanitiser can fall within one of three broad regulatory regimes:
- Cosmetic: where the product has the primary function of cleaning or protecting the skin.
- Biocidal: where the product's primary claimed purpose is to kill germs, disinfect or sanitise.
- Medical: where the specific purpose of the product is for use in a clinical setting or where the product's claimed purpose is to treat or prevent disease in human beings.
It is likely that hand sanitiser manufactured for use in the Covid-19 pandemic will be either biocidal or medical. Manufacturers should think carefully about the intended primary function and how the products are marketed because the regulatory framework for medical products is more onerous than for biocides or cosmetics.
There are also different composition requirements depending on the categorisation of your product. Public Health England has advised that, in general, hand sanitisers should have 60% or higher alcohol content to be effective against the Covid-19 virus. However, sanitiser manufactured for use in a clinical setting may require a higher alcohol content.
Relaxation of the regulatory regime for hand sanitising products
The government has produced guidance on the temporary changes to the use and supply of denatured alcohol and duty-free spirits.
If you're already producing hand sanitiser:
- If you are authorised to use duty-free spirit to produce hand sanitiser for hospitals, you will be automatically authorised to produce sanitiser for care homes.
- If you are authorised to use trade specific denatured alcohol 1 (TSDA1) or duty-free spirits used to produce hand sanitiser for retail or hospital use, you do not need to apply to increase your annual usage limit.
- If you are authorised to use trade specific denatured alcohol 6 or 7 (TSDA6 or TSDA 7), you can begin to produce hand sanitiser.
If you want to produce hand sanitiser:You are authorised to use industrial denatured alcohol (IDA), TSDA1, TSDA6 or TSDA7, or duty-free spirit (though the latter is permitted only where hand sanitiser is for supply to hospitals and care homes).
- You must, however, apply to HMRC in the normal way before producing hand sanitiser, unless you are a licensed distiller or gin manufacturer in which case other requirements apply – see this link for further information.
HMRC is prioritising applications to use denatured alcohol in hand sanitising products, meaning that any such applications made during the Covid-19 pandemic will be fast-tracked, with HMRC aiming to process requests within five working days.
Only applications for IDA and TSDA1 used in the manufacture of sanitiser will be fast-tracked.
The Health & Safety Executive (HSE) has also issued guidance on the manufacture and supply of biocidal hand sanitiser products during the Covid-19 pandemic. This sets out the position in respect of sanitisers containing Propan-2-ol and Propan-1-ol or Ethanol.
For hand sanitisers containing Propan-2-ol:
- Article 55(1) Biocidal Products Regulation provides for short term derogations from the requirements for product authorisation, meaning that such products will not be required to obtain a product authorisation if they meet the relevant World Health Organisation (WHO)-specified formulation II.
- Manufacturers wishing to market products that meet this formulation are required to contact HSE in order to obtain a derogation certificate. Importantly, products should not be placed on the market until HSE has confirmed that the derogation applies to your product and you have been issued with the requisite certificate.
For hand sanitisers containing Propan-1-ol or Ethanol:
- Sanitisers containing Propan-1-ol: the Article 55(1) derogation set out above may in theory apply to sanitisers containing Propan-1-ol. However, as WHO does not specify a formulation for hand sanitiser containing this ingredient, more information will be required from applicants in order for HSE to properly assess the products. You should therefore be prepared for any such applications to take longer to process.
- Sanitisers containing Ethanol: the WHO-specified formulation I applies to this type of sanitiser. Products containing ethanol do not require product authorisation in order to be marketed in the UK.
The government has also provided assistance to local authorities, ports and border enforcement officers on the import and safety testing of hand sanitiser.
The regulatory framework surrounding medical devices was due to move from the Medical Devices Directive 93/42/EEC to the EU Medical Devices Regulations 2017/745.
The European Commission has adopted a proposal to postpone the application of the new Regulations which were due to come into force on 26 May 2020 for one year in light of the challenges posed by Covid-19. There have also been exemptions from standard device regulation in order to ensure availability of ventilators as the Covid-19 crisis continues.
Relaxation of the regulatory regime for ventilators
The Medicines and Healthcare products Regulatory Agency (MRHA) has confirmed flexibilities in the regulatory regime and has issued specifications for Continuous Positive Airway Pressure and Rapidly Manufactured Ventilator System equipment.
Exceptional use applications are being processed to ensure a continued supply of non-CE marked medical devices where there is a demonstrated clinical need and a lack of availability of CE marked devices. In the case of ventilators, manufacturers should check the required specification and then contact the Department of Health and Social Care by email .
Personal Protective Equipment
The regulatory framework for PPE, such as non-surgical face masks and gloves, is EU Regulation 2016/425 which covers the design, manufacture and marketing of PPE. All PPE equipment should undergo a conformance assessment and be affixed with a CE mark which provides evidence of the product's compliance with the regulatory requirements. However, this process is time-consuming and is proving unworkable for PPE manufacturers to quickly get urgently required products to market in the current Covid-19 context.
Relaxation of the regulatory regime for PPE products
The government has introduced the following temporary measures in an effort to boost availability of essential products:
- asking the HSE and Local Authorities to fast-track PPE through the product safety assessment process as a priority; and
- allowing PPE products that provide protection against Covid-19 infection onto the market without a CE mark (provided that the products meet the essential safety requirements as set out in the EU Regulation).
The government has also issued guidance on the specific regulatory status of individual items of PPE.
There are currently a number of exceptions and exemptions from the regulatory framework governing certain products, with the possibility of more coming down the track as the Covid-19 pandemic persists. If you are seeking to diversify your current product offering, although the relaxed regulatory regime is helpful, it is important to continue to ensure that all products comply with any safety requirements which are still required to be met. Failure to meet the requirements can result in a criminal offence being committed and penalties include unlimited fines, imprisonment for a term of up to three or six months (for individuals convicted of an offence), or both.
As the Covid-19 pandemic evolves, we may see calls from manufacturers for the government to go further in its relaxation of requirements to enable them to keep up with demand. It remains to be seen whether any of these relaxed requirements remain in place once the pandemic is over or whether there will be a review of the efficacy of the more stringent measures that existed beforehand once the government is afforded the benefit of hindsight.