The coronavirus (COVID-19) crisis has a significant impact on companies operating within the fields of medicinal products and medical devices. Many regulatory authorities have introduced extraordinary measures to manage and mitigate the negative impact of the COVID-19 pandemic. In this update, we highlight some of the current measures put in place by the main regulatory authori-ties with respect to clinical trials, medicinal products and medical devices.
The COVID-19 pandemic has a significant impact on the conduct of clinical trials as the trial participants may be quarantined or otherwise hindered from following the protocol. Further, access to trial sites may be restricted, which may impact trial visits and the supply of investigational medicinal products and medical devices. Lastly, the work force at trial sites may be under significant pressure to handle other critical tasks.
Acknowledging the impact of COVID-19 on the pharmaceutical and medical device companies – and the broader society – many regulatory authorities responsible for monitoring clinical trials have put in place extraordinary measures and provide special guidance to manage and mitigate the negative impact of the COVID-19 pandemic on the conduct of clinical trials.
In light of the COVID-19 pandemic, the European Commission – in collaboration with several other parties, e.g. the European Medicines Agency, the Good Clinical Practice Inspectors Working Group and the Clinical Trials Facilitation and Coordination Group – have published a guidance for all parties involved in clinical trials.
The guidance addresses the matter of initiating new trials. According to the guidance, the feasibility of starting new clinical trials or including new trial participants in ongoing trials should be critically assessed by the sponsors.
The guidance specifically provides that sponsors are expected to conduct risk assessments of each individual ongoing trial and that sponsors should consider whether to adjust their clinical trials on the basis of such risk assessments. Naturally, the safety of the participants are of primary importance, and the anticipated benefit for the participants and society should be weighed against the added challenges and risks due to COVID-19. If the risk assessment leads to actions affecting the clinical trial, the relevant competent authorities and ethics committees must be informed in accordance with the European and national framework.
The guidance maintains that sponsors are expected to continue safety reporting and that the involved investigators must maintain ways of collecting adverse events even if trial visits are postponed or cancelled.
The guidance also provides that in case a sponsor plans to initiate a trial aiming to test new treatments for COVID-19, advice should be sought on alternative procedures to obtain informed consents as it may not be possible to obtain written consents from COVID-19 patients.
The guidance also addresses the matter of changes in distribution of investigational medicinal products and medical devices, and the matter of monitoring and auditing.
Please find the European Commission’s guidance on the management of clinical trials during the COVID-19 pandemic here.
On national level, the Danish Medicines Agency has issued guidance on extraordinary measures for clinical trials due to COVID-19, stressing, i.a., the importance of sponsors conducting risk assessments and escalating and managing any protocol deviations. The Danish Medicines Agency recommends handling COVID-19-related changes as “Urgent Safety Measures” which can be implemented without the approval from the Danish Medicines Agency.
The guidance also provides that the Danish Medicines Agency has reduced the time of first response for clinical trials investigating treatment or prevention of COVID-19. The Danish Medicines Agency has also stated that it will prioritize all requests regarding regulatory aspects in clinical trials with medicinal products in regards to COVID-19. Any communications to the Danish Medicines Agency in this regard should be directed to firstname.lastname@example.org and should be clearly marked with “COVID-19” and the EudraCT number in the subject field.
Further, the guidance states that it should be considered whether it may be appropriate to postpone initiating and recruitment for other clinical trials, and whether to postpone on-site visits or transferring such visits to telephone consultations.
The guidance from the Danish Medicines Agency contains detailed guidance as to the procedures for and format of notifications, as well as recommendations for handling changes to distribution of investigational medicinal products.
Please find the Danish Medicines Agency’s guidance (in English) here.
The Danish Health Data Authority has stated that research projects concerning COVID-19 are prioritized, as applications for access to data (e.g. data in the National Patient Register) in connection with COVID-19 related research projects are being fast-tracked and jump the queue. Please find a link to the Danish Health Data Authority’s information on the fast-track here.
The two new medical device regulations (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices) are currently set to enter into force and become applicable by 26 May 2020.
However, during a press conference held on 23 March 2020, the European Commission stated that it is working on a proposal to delay the entry into force of the new medical device regulations for one year considering the COVID-19 situation.
According to the Commission, this will release the national authorities and the industry from the pressure of implementing the regulations and allow them to focus fully on urgent priorities related to coronavirus crisis.
The Danish industry association for companies developing, manufacturing or selling medical devices (Medicoindustrien) agrees with the European Commission’s proposal to postpone the implementation of the medical device regulations as member states, notified bodies and the industry are currently under significant pressure.
Please find an audio visual excerpt from the press conference of the European Commission here.
The Danish Medicines Agency has the responsibility of inspecting the development, manufacture, distribution, dispensing and monitoring of medicines and medical devices. However, due to the COVID-19 pandemic – to contain the spread of the virus – the Danish Medicines Agency has stated that it will be putting all on-site inspections and laboratory controls on hold until further notice. Thus, the Danish Medicines Agency will only be conducting on-site inspections if there is a potential risk to patient safety.
However, office-based assessments will still be carried out, and the Danish Medicines Agency is working with the European Medicines Agency to find common control methods to be used during the pandemic.
In a recent update we have provided information on two recently issued Danish executive orders relating to the supply of medical devices, personal protective equipment and disinfectants in connection with the management of COVID-19.
The purpose of the issuance of the executive orders is to ensure sufficient supply of medical devices, personal protective equipment and disinfectants to regions, municipalities and hospitals. In order to reach this purpose, the executive orders introduce wide powers for the Danish Medicines Agency to impose extensive obligations on Danish companies.
Please find the update on the two executive orders here.
Gorrissen Federspiel is closely following the developments to keep its clients well-aware of the current situation within the pharmaceutical and medico fields.