This week, we look at new initiatives in the EU for fast tracking COVID-19 treatments and new guidance in the UK on PPE and CPAP systems. In the US, we consider new FDA guidance on COVID-19 exemptions and exclusions to requirements under the Drug Supply Chain Security Act.
Medicines – New EMA initiatives to fast-track development support for COVID-19 treatments
The European Medicines Agency ("EMA") has published a series of rapid review procedures for fast-track assessment so that market authorisations ("MAs") for COVID-19 related medicines can be granted quickly. These procedures apply to new medicines as well as approved medicines that are being repurposed for COVID-19 and include:
- scientific advice from the EMA, provided free, with a maximum total review time of 20 days;
- reducing review time for paediatric investigation plans ("PIP") from 120 days to 20 days, as well as implementing four day compliance checks of MA applications against relevant PIPs;
- rolling assessments of data supporting highly promising MA applications, which can precede formal submission of a new MA application;
- accelerated assessment of medicines in less than 150 days, a reduction from the usual 210.
Developers are encouraged to start discussions with the EMA as early as possible to accommodate the accelerated procedures.
The EMA has also announced that it's working on an update to the Q&A for holders of MAs for human medicines. We expect this to address the current challenges posed by the COVID-19 pandemic, and clarify some points contained in its current guidance (which we previously reported on here). We will keep you updated on this topic as it develops.
PPE – New Guidance and Zero VAT
The UK's Office for Product Safety and Standards ("OPSS") has released a new version of its Guidance for high-volume manufacturers of PPE designed to assist in the COVID-19 pandemic. The new version of this Guidance clarifies that:
- The UK will interpret the EU regulatory easements on PPE afforded by EU Recommendation 2020/403 as applicable to PPE intended to protect UK workers in any COVID-19 context, not solely in the context of the use of PPE by healthcare workers.
- PPE manufacturers seeking to rely on the relaxation of requirements to carry out a conformity assessment before placing PPE on the market must submit a formal application to their relevant Notified Body, an email notification will not suffice.
The government has introduced a measure granting temporary VAT zero rate to all supplies of PPE that are recommended by Public Health England in its guidance and made between 1 May 2020 and 31 July 2020. Under the standard regime, a VAT rate of 20% applied to the sale of PPE.
Products subject to the VAT zero rate include:
- Disposable gloves
- Disposable plastic aprons
- Disposable fluid-resistant coveralls or gowns
- Surgical masks
- Filtering face piece respirators
- Eye and face protection
Medical Devices – New MHRA Guidance on Rapidly Manufactured CPAP System Specifications
The Medicines and Healthcare products Regulatory Agency ("MHRA") has published guidance on clinically-acceptable Continuous Positive Airway Pressure ("CPAP") ventilation systems to be used in UK hospitals during the COVID-19 pandemic.
The guidance outlines mandatory requirements, desirable features and lower priority features, based on a consensus in the opinion of anaesthesia and intensive care medicine professionals and medical device regulators. It states that CPAP systems that fall below the outlined specifications are unlikely to provide any clinical benefit, and might lead to increased harm. As a result, the MHRA suggests that in the midst of this crisis it's imperative that manufacturers adhere to the minimum standard it outlines.
Medicines – Reporting Side Effects and Equipment Incidents
The MHRA has launched a new and tailored website Coronavirus Yellow Card to enable healthcare professionals carers and patients to report medicine side effects or incidents in connection with medicines and/or equipment used in the fight against COVID-19.
The site is intended to increase the speed by which reports can be made and new risks identified and tackled by the regulator.
On April 30, 2020, the U.S. Food and Drug Administration ("FDA") published guidance clarifying the nature and scope of exemptions and exclusions to certain requirements under the Drug Supply Chain Security Act ("DSCSA") triggered by the COVID-19 public health emergency. By waiving certain requirements under the DSCSA for the duration of the COVID-19 public health emergency, the FDA seeks to ensure that prescription drug products are distributed effectively throughout the supply chain to combat COVID-19.
Enacted in 2013, the DSCSA amended the Federal Food, Drug and Cosmetic Act ("FDCA") and established product tracing, product identification, authorized trading partner and verification requirements for pharmaceutical manufacturers, wholesale distributors, repackagers, dispensers and third party logistics providers in order to facilitate the tracing of certain drug products through the pharmaceutical distribution supply chain. The DSCSA seeks to build an interoperable electronic system that identifies and traces prescription drug products at the individual unit level through all stages of the pharmaceutical supply distribution chain by November 2023.
Notably, the DSCSA automatically excludes from certain of its requirements specific activities pursuant to the declaration of a public health emergency by the Secretary of the U.S. Department of Health and Human Services ("HHS"). Specifically, the distribution of a pharmaceutical product for emergency medical reasons, including a public health emergency declaration, is exempted from the definition of a "transaction" and excluded from the definition of "wholesale distribution" under the DSCSA.
The newly issued guidance clarifies that the statutory exemption and exclusion apply to the distribution of covered COVID-19 products, including prescription drug products issued an emergency use authorization ("EUA") by the FDA, or products approved by the FDA to diagnose, cure, mitigate, treat or prevent COVID-19. The FDA states that the exemption and exclusion will also apply to other affected products directly impacted by the COVID-19 public health emergency, including but not limited to those used to treat symptoms of COVID-19 or to provide supportive care to patients with severe cases of COVID-19.
As such, trading partners are not required to comply with certain product tracing and product identification requirements triggered by a "transaction" pursuant to the distribution of covered COVID-19 products. However, the FDA emphasizes that trading partners distributing products for purposes unrelated to the COVID-19 public health emergency are still required to comply with all applicable DSCSA requirements in connection with the distribution of the product. Moreover, the exemption does not apply to other DSCSA requirements that are not triggered by a "transaction" including having a valid registration with the FDA; licensure for authorized trading partners; or verification processes in connection with the quarantine and investigation of suspect product, and the quarantine and disposition of illegitimate product.
The guidance further states that wholesale distributors are not required to comply with the licensure provisions, reporting requirements or wholesale distributor requirements under the DSCSA for activities related to the distribution of covered COVID-19 products. However, an entity engaged in activities meeting the definition of "wholesale distribution" but unrelated to the COVID-19 public health emergency is still required to comply with applicable DSCSA requirements. The FDA also emphasizes that states may still require licensure of wholesale distributors pursuant to applicable state law.
The guidance notes that while the DSCSA's requirement to trade only with authorized trading partners remains in effect for the duration of the COVID-19 public health emergency, the FDA does not intend to take enforcement action against trading partners engaging in COVID-19-related product distribution involving entities that would otherwise meet the definition of "wholesale distributor" under the DSCSA save for the exclusion described herein, or trading partners that are not authorized solely due to circumstances directly related to the COVID-19 public health emergency, and that are otherwise working with, or authorized by state authorities to operate during the COVID-19 pandemic.
Please note that the exemption and exclusion from certain DSCSA requirements outlined in the guidance apply only for the duration of the COVID-19 public health emergency. For further information regarding how the waiver of certain DSCSA requirements may affect your company's operations, please reach out to your local Cooley attorney.
Regulators in the EU, UK and US continue to take measures in response to COVID-19 – rolling them out at a speed, and with a scope, previously unseen. PPE remains a focus area, and we anticipate that this will remain the case as the global community starts to lift initial lockdown measures and adjust to the "new normal". Regulators' attention has also turned to medical devices that have proven effective in the treatment of COVID-19 symptoms (like CPAP), and to how they can support manufacturers to develop treatments – including, where appropriate, by relaxing or waiving usual requirements.
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