Fieldfisher’s global life sciences and healthcare sector group is equipped to support organisations mobilising against the rapid spread of COVID-19. Whether you need regulatory, IP or commercial advice we are on hand to help you find out what hurdles need to be overcome. Or perhaps you need support with a range of corporate transactions to give you the financial backing to contribute towards the global effort. With hubs in all the key international jurisdictions, whatever support you’re looking for our expert lawyers can help.
Country by country update
- How do we prioritise supply chain issues when it comes to medication and treatment?
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.
- I would like to access funds to enable Covid-19 research, how can I do this?
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.
- 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 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.
- I would like to trial a treatment for Covid-19. How do I get my product to patients quickly but safely?
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.
- My hospital is running low on Personal Protective Equipment (PPE), what are the legal implications?
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.
- I am a healthcare professional. What do I need to know about the impact of Covid-19 on my practice?
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).
- As a pharmaceutical company, do we have any additional reporting or supply obligations due to 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.
- 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?
- In the context of clinical trials, how do I get my product to patients quickly but safely?
- What happens to the contentious matters before a Court in which we were a party? Can we currently file new claims?
- 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?
- Most of our products are purchased by the public administration. Are there any new measures regarding public procurement of which we should be aware?
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.