Coronavirus Life Sciences sector update

1. How do we prioritise supply chain issues when it comes to medication and treatment?

Although the risk of disruption to supply chains generally is low at present, there are a number of steps that authorisation holders, manufacturers, distributors, etc. can consider in anticipation of any potential impacts:

Communication: Remain in regular contact with customers and suppliers in order to:

• reassure customers that supply will continue and that stockpiling is unnecessary; and,
• identify any potential supply disruptions as soon as possible in order to develop and/or implement contingencies. Any actual supply disruptions, and the stated reasons for same, should be carefully documented in anticipation of any future dispute.

 
Monitoring: Review inventories and audit supply chains in order to identify the products that are most at risk from supplier shutdowns or logistics interruptions. Prepare for these high risk outcomes by identifying alternative suppliers and channels.
 

Contracts: Carefully review agreements with the suppliers and customers that are most likely to be affected, with a specific focus on:

• consequences of a breach of contract;
• remedies available;
• obligations to mitigate risks; and,
• force majeure clauses.

 
Insurance and/or indemnification agreements should also be carefully reviewed to establish whether or not losses caused by an event such as Covid-19 are covered. Prompt notification and communication with insurers/indemnifiers in relation to any such losses should also be a priority.
 

2. I would like to access funds to enable Covid-19 research, how can I do this?

The Health Research Board in cooperation with the Irish Research Council have launched a rapid response mechanism to fund COVID-19 research that is aligned with the WHO R&D Blueprint and informed by the Global Infectious Disease Collaboration for International Disease Preparedness (GloPID-R). The scope of this funding call covers medical countermeasures, health service readiness, and social and policy countermeasures to COVID-19. Expedited timelines apply throughout the process. It is expected that contracting and start-up of successful projects is equally expedited, and that project staff will mostly be redeployed rather than specifically recruited. Host Institutions are required to treat awards arising from the call with utmost urgency. Guidelines in relation to the call can be found here.

Since the beginning of the crisis in January, the European Commission has also invested in several high priority research calls to further research into rapid diagnostic testing, treatment options, vaccines, and general pandemic and epidemic preparedness. In cooperation with the pharmaceutical industry, around €140m will be available to support research into COVID-19. A number of EU-funded projects that are already operating are also contributing to the response to the virus outbreak. Further detail in relation to these research initiatives are available here.
             

3. I run a manufacturing company and would like to start producing ventilators, what do I need to know? My business manufactures medical devices, how can I start manufacturing ventilators?

In response to the urgent need for high performing devices (such as ventilators) to be placed on the European market, the European Commission has now adopted decisions on harmonised standards for such devices being placed on the European market. The agreed standards (available here) allow device manufacturers to demonstrate conformity to the EU Medical Devices Directive (93/42/EEC) and provide companies with a more streamlined pathway to the internal market for their products, whilst also ensuring a high degree of safety for users and consumers.

In Ireland, the Health Products Regulatory Authority ("the HPRA") has developed a process for the urgent assessment of applications to use non-CE marked medical devices in this jurisdiction. This process is specifically addressed to regulatory derogations for the management of the COVID-19 pandemic. The HPRA has stated that it will conduct an initial review of such submission and will work with the consultant and manufacturer applicant to complete the review as quickly as possible.

The HPRA also has a compassionate use process for authorisations in accordance with article 11.13 of the Medical Devices Directive, which applies to an individual patient use of a single device.
 

4. I would like to trial a treatment for COVID-19. How do I get my product to patients quickly but safely?

The Health Products Regulatory Authority ("the HPRA") is continuing to update its guidance on the management of clinical trials. Priority is currently being given to review of regulatory submission relating to COVID-19. The most recent guidance is accessible here.

The EU Commission, the European Medicines Agency and the national Head of Medicines Agencies have also published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic.
 

5. My hospital is running low on Personal Protective Equipment (PPE), what are the legal implications?

In Ireland, as elsewhere, concerns around adequate supply of PPE to healthcare workers are growing as the virus continues to spread. The HSE's Health Protection Surveillance Centre has published guidance on the use of PPE in the management of suspected or confirmed COVID-19.

Although not specific to the healthcare setting, Section 8 of the Safety, Health and Welfare at Work Act, 2005 places a duty on employers to supply PPE where risks cannot be eliminated or adequately controlled. Further rules regarding use of PPE are also provided for by the Safety, Health and Welfare at Work (General Application) Regulations 2007, Part 2, Chapter 3. As hospital staff continue to work through what is an unprecedented challenge, managers should ensure that all available steps to ensure the health and safety of front line staff are taken. 

As the challenge of managing and treating the spread of the virus increases, steps are also being taken to safeguard the supply of PPE within the EU, and to streamline the assessment of PPE that qualify as medical devices such as surgical masks and other equipment intended to be used in a medical, surgical or dental setting. Further information in relation to these initiatives is available here.
 

6. I am a healthcare professional. What do I need to know about the impact of COVID-19 on my practice?

The various statutory bodies responsible for regulation of the healthcare professions in Ireland have published statements and further information and guidance to their members in response to the issues and challenges created by the COVID-19 pandemic.

The Medical Council has made a comprehensive suite of updates and information relating to COVID-19 available to its members here.

CORU, the statutory body with responsibility for regulating a number of health and social care professionals such as radiographers, speech and language therapists, social workers, occupational therapists and physiotherapists has also published a series of updates in relation to registration, recognition, education, continuing professional development, fitness to practice and appeals here.

Nursing and Midwifery Board of Ireland ("NMBI") statements relating to registration and Fitness to Practise Inquiries are available here and here and information for nurses and midwives on scope of practice in emergency situations is also available here.

The Pharmaceutical Society of Ireland has also published further information in relation to changes to operations and its regulatory activities (here) as well as a joint communication from the President, Joanne Kissane, and the Registrar, Niall Byrne, to pharmacists, pharmacy owners and staff (here).

1. As a pharmaceutical company, do we have any additional reporting or supply obligations due to the Coronavirus crisis?

 Yes. The Ministry of Health has recently adopted several measures in order to ensure the supply of certain medicinal products, medical devices and health products deemed essential to tackle the Coronavirus crisis.
 
Manufacturers and importers of medical devices and other health products have the obligation to report on the available units and daily units they manufacture or import, while manufacturers and marketing authorisation holders (MAHs) of medicinal products are obliged to report their stock, the number of supplied units and released batches regarding certain essential medicinal products on a daily basis.
 
In both cases, companies also have the obligation to keep supplying these products. These supply obligations are especially strict for manufacturers and MAHs of medicinal products, given that they are obliged to ensure that all needs that health services and facilities may have are properly covered, including on holiday periods and weekends.
 
 

2. We were supposed to attend a conference abroad but the organiser has cancelled the event. Can we cancel our flights to where the event had to take place and get a full refund?

According to the recently published Notice by the European Commission regarding Interpretative Guidelines on EU passenger rights regulations in the context of the developing situation with COVID-19, if flights are cancelled, passengers can choose between full reimbursement of the price of the flight or re-routing at a later state. However, if passengers cannot travel or want to cancel a trip on their own initiative, as it would be deemed in this case, whether or not said passengers are reimbursed depends on the type of ticket (reimbursable, possibility to rebook) as specified in the carrier's terms & conditions.
 
 

3. In the context of clinical trials, how do I get my product to patients quickly but safely?

 The Ministry of Health exceptionally allows, if it is established by the competent authorities of each autonomous community, that patients who participate in a clinical trial receive their medication at home. In such case, the sponsors of the clinical trial shall provide the necessary logistics, under the direction of the corresponding Hospital Pharmacy Service and the principal investigator of the clinical trial. Thus, clinical trial sponsors should contact both the competent authorities and hospitals in order to provide this kind of service.
 
 

4. What happens to the contentious matters before a Court in which we were a party? Can we currently file new claims?

Since 14 March 2020, when the State of Alarm was declared, all judicial and administrative deadlines have been suspended, with limited exceptions. Therefore, all proceedings haven been halted, and outside the scope of the foreseen exceptions, only measures to ensure that the rights and interests of the parties are not severely or irreparably harmed can be adopted. All deadlines shall resume once the State of Alarm ends, but the deadlines will not restart.
 
Furthermore, it is important to point out that, although the Spanish General Council of the Judiciary had initially stated that no new claims could be filed until the State of Alarm ended, the same Council and the Ministry of Justice have recently agreed to accept any new claims and writs submitted to the Courts, even though all non-urgent proceedings will still remain suspended.

 
 

5. Does our clinical trial insurance policy cover all damages that may be claimed if the subjects of the trial contract SARS-Cov-2 and suffer any consequences from it?

 Insurance policies for damages in the context of a clinical trial usually cover for all damages caused to participants of the clinical trials caused by the said clinical trial. Therefore, if the participants contract SARS-Cov-2 and a Court establishes that either it has been caused by the participation in the clinical trial or that the consequences of contracting SARS-Cov-2 have been worsened by the clinical trial, the insurance policy will usually cover such damages. However, this will not be the case if this circumstance has been expressly foreseen as an exclusion of coverage in the insurance policy. In any case, this should always be assessed on an individual basis.
 
 

6. Most of our products are purchased by the public administration. Are there any new measures regarding public procurement of which we should be aware?

 Public procurement is one of the most affected areas by the new measures adopted by the Spanish Government. On the one hand, any public contracts with the State Public Administration to deal with COVID-19 can be undertaken though the emergency procedure, which allows many exceptions to the ordinary procedure for public procurement.
 
On the other hand, several measures have been adopted for existing contracts, in regards to delays or to the subject of the contract being impossible, due to the COVID-19 crisis or the measures adopted by the Spanish Government, in which case the consequences are mitigated, by such measures as suspending and not terminating the contract, exemptions on fines and the damages compensations from the Public administration.

1. Coronavirus: Drug shortages and parallel exports – What do I need to know?

At the time of writing, more than 80 crucial medicines used to treat coronavirus patients have been banned from parallel export from the UK.

As the coronavirus (COVID-19) pandemic increases rapidly on a daily basis, the UK Department of Health and Social Care (DHSC) last week has banned 80 "crucial" medicines which are in high demand across Europe from parallel export, to ensure a consistent supply for UK patients who need them.

The "crucial" medications which include adrenaline, insulin, paracetamol and morphine are commonly used in intensive care units and are needed to treat patients who are seriously ill with Covid-19.

Parallel export of medicines is based on a principle of free circulation of goods and services. This means that medicines can be purchased and sold across national borders, while keeping the international rules of pharmaceutical trade. Parallel exports therefore are medicines that are sold to another European Member State (or even a European country outside the EU) and are then distributed by the parallel importer on its domestic market.

Companies that parallel export a medicine on the ban list from the UK may face tough enforcement action from the Medicines and Healthcare products Regulatory Agency (MHRA) and risk having their trading licence revoked for serious breaches.

The full list of medicines banned from parallel export can be found here.

 

2. What guidance is there to fast track the regulatory approval process for COVID-19 clinical trials in the UK and beyond?

In unprecedented medical situations such as the pandemic effects of the coronavirus, a clinical trial to help identify and provide medicinal treatment will typically focus on key priority questions in order to improve public health such as:

• Does the medicine reduce mortality rates?
• Does the medicine reduce the time a patient is in hospital?
• Do patients receiving the medicine need ventilation and intensive care unit treatments?

In an effort to fast track the clinical trials approval process yet ensure patient safety is maintained as best it can, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has stated that it currently has procedures in place for the provision of rapid scientific advice, study reviews and priority approvals for COVID-19 clinical trials which are submitted in efforts to support manufactures, researchers and other regulators.

The MHRA could potentially authorise the initiation of a Phase I clinical trial in as little as one week following the receipt of appropriate documentation. In the event that the Phase I trial results are positive in animal studies, researchers could move to conducting tests in humans within a matter of months.

The primary challenge for researchers and regulatory authorities will be to balance potential trial risks against the benefits for the speedy release of a medicine. Notwithstanding the ability to fast track trials researchers will still be required to adhere to the UK Medical Research Council (MRC) guidelines for good clinical practice (GCP) and undergo extensive testing to ensure its efficacy and safety prior to obtaining regulatory approval.
 
 The MHRA has published a guidance document for Clinical trials applications for Coronavirus (COVID-19) which can be read here.
 
Working alongside the MHRA in an attempt to fast track the COVID-19 regulatory approvals process for clinical studies, the UK's Health Research Authority (HRA) which protects and promotes the interests of patients and the public in health and social care research will also expediently process research applications.  This means that researchers receive trial approval to begin much more quickly than the usual timelines, sometimes in a matter of hours. Whilst emergency applications are still subject to a robust ethics review. The Director of the Approvals Service can either arrange for an existing Research Ethics Committee (REC) to hold an extraordinary meeting, or for a new REC to be formed to consider a particular application.

On a global scale, the World Health Organization (WHO) last week announced a large global trial, called SOLIDARITY, to find out whether any can treat infections with the new coronavirus for the dangerous respiratory disease. It’s an unprecedented effort—an all-out, coordinated push to collect robust scientific data rapidly during a pandemic. The study, which could include many thousands of patients in dozens of countries, has been designed to be as simple as possible so that even hospitals overwhelmed by an onslaught of COVID-19 patients can participate.

 

3. Running low on Personal Protective Equipment (PPE), what are the legal implications?

On Friday 20 March, Public Health England published a guidance document on the on supply and use of Personal Protective Equipment (PPE) for use by all NHS staff. The guidance reduces the level of the PPE that staff need to wear.

Previously for example in efforts to protect the respiratory airways, healthcare staff were advised to wear full PPE, comprising an FFP3 masks, visors, surgical gowns and two pairs of gloves each. However, the new advice recommends a standard surgical face mask, short gloves and a plastic apron. The content of the document can be read here.

Currently in the UK there is a shortage of PPE equipment. Based on World Health Organisation (WHO) modelling, an estimated 89 million medical masks are required for the COVID-19 response each month. For examination gloves, that figure goes up to 76 million, while international demand for goggles stands at 1.6 million per month. Recent WHO guidance calls for the rational and appropriate use of PPE in healthcare settings, and the effective management of supply chains. To meet rising global demand, WHO estimates that industry must increase manufacturing by 40%.

Employers have a duty of care under the Control of Substances Hazardous Health 2002 (COSHH) to assess and reduce the risks from exposure to biological hazards to employees. Under COSHH employers need to identify who may be harmed by a biological agent through risk assessment and how they may be exposed.

Guidance from Public Health England, Health Protection Scotland and the Health and Safety Executive outlines the procedures required in the COSHH assessment and what steps need to be taken including the identification of potential patients with COVID-19, isolation procedures and precautions such as negative pressure ventilation and the provision and safe use of appropriate personal protective equipment (PPE).