Effective date of EU Medical Device Regulation now officially delayed by 1 year

On 23 April 2020, the European Parliament and Council approved the European Commission’s proposal to delay the application date of the Medical Device Regulation 2017/745 (the “MDR”) by one year (from 26 May 2020 to 26 May 2021) by adopting New Regulation (EU) 2020/561 (the “New Regulation“).

Unusually, the New Regulation took effect on the date of its publication in the Official Journal of the European Union, i.e., on 24 April 2020.  Typically, regulations come into effect the day after publication.  However, an accelerated postponement of the MDR was deemed necessary in light of the current pressure on the medical device industry caused by the COVID-19 pandemic.  This is expressly recognized in the recitals of the New Regulation:

The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to Member States and constitutes an immense burden for national authorities, health institutions, Union citizens, and economic operators… Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give necessary medical treatment to patients who are urgently in need of such treatment.

 …Given the unprecedented magnitude of the current challenges, and taking into account the complexity of [the MDR], it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as laid down therein.” (Emphasis added.)

The New Regulation also amends Article 59 of the MDR, which allows (i) EU Member State authorities to grant national derogations for placing on the market or putting into service specific medical devices that are not yet CE-marked if “in the interest of public health or patient safety or health”; and (ii) in certain instances, the Commission to extend such derogations to the whole of the EU.  The original version of Article 59 was limited to national derogations obtained under the MDR.  However, the New Regulation extends the scope of the Article to include national derogations granted under the currently applicable Medical Devices Directives 93/42/EEC and 90/385/EEC.  This provides flexibility for the Commission to extend a national derogation granted by a Member State under the existing medical devices rules to the entire EU territory.  This essentially means that Article 59 of the MDR has immediate effect, which will be particularly useful as companies quickly try to bring products to the market to combat the COVID-19 pandemic.

As discussed in our previous InsideEULifeSciences blog post, the delay to the MDR will be welcome news to all manufacturers of medical devices intended for the EU market, as well as other economic operators in the supply chain.  The postponement of the implementation date will allow companies to deploy resources to address the current pandemic and will give them extra time to become MDR-compliant.

Finally, it is worth noting that the new application date (i.e., 26 May 2021) means that the full applicability of the MDR will fall now outside of the transition period agreed between the UK and the EU.  The UK Medicines and Healthcare products Regulatory Agency (the “MHRA”) has confirmed that it is “taking steps to plan for after the end of the transition period” and that “it will provide guidance on this in due course in light of Government decisions required on the future of UK regulation.”   The MHRA also confirmed that elements of the MDR have in any event applied directly in UK law since May 2017, meaning medical devices can now be legally placed on the UK market if they are in conformity with the MDR, invoking all relevant requirements.

Ireland’s HPRA to fast-track review of Covid-19 related Clinical Trials and Clinical Investigations

The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19.

The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19).

Applications for clinical trials of human medicines or clinical investigations of medical devices will be given priority and an expedited review by HPRA. The NREC-COVID-19 will review applications concurrently with the regulatory review processes and will endeavour to facilitate an expedited ethical review (see: COVID-19 Related Human Research – Expedited Regulatory and Ethical Review).

This fast-track process is likely to be of interest to the very many global pharma, biotech and device manufacturers already based in Ireland but it will also make Ireland a more favourable jurisdiction in the EU for COVID-19 related human health research.

Belgium replaces COVID-19 medicines export ban to non-EEA countries with system of export control

As previously reported on this blog, on 1 April 2020 Belgium adopted a complete ban on exports of certain medicines and raw materials to non-EEA countries to avoid shortages during the COVID-19 outbreak. On 8 April 2020, Belgium reversed this ban, and instead installed a system of export controls. Coincidentally or not, the same day the European Commission also issued guidelines to the member states on the rational supply of medicines.

Below I discuss the new approach to exports within and outside the EEA from Belgium.

1. Total export ban under the Decision of 1 April 2020

Article 3 of the Decision of the Federal Agency for Medicines and Health Products (“FAHMP”) of 1 April 2020 (“old Decision”) was drafted as a total export ban within and outside the EEA.  By way of exception, EEA exports were lawful subject to prior notification to the authority.  It did not provide for an exception for exports outside the EEA.  It was the news article on the FAHMP website of 2 April 2020 that stated that exceptions could be requested for exports outside the EEA.  This approach was highly questionable under EU law.

Article 3 of the FAHMP Decision of 8 April 2020 (“new Decision”) has essentially reversed the total export ban.

2. Non-EEA exports under the Decision of 8 April 2020

Pursuant to article 3(1), exports outside the EEA are now in principle permitted, subject to prior notification and insofar the Minister or the FAHMP have not opposed the export within three working days “after” the notification.  The opposition will be communicated by email to the notifying wholesaler.  The language of this provision suggests that if a company has not heard of the FAHMP within that period, the non-EEA export can go ahead.

The Decision states that the export outside the EEA can be refused if there is an “acute or imminent shortage of the relevant medicines or raw materials, insofar the available volumes are insufficient to fulfill the needs of patients in Belgium during the upcoming four weeks.  The availability of an alternative, therapeutic equivalent alternative is taken into account, as well as the needs for the treatment of COVID-19 patients, on the basis of current epidemiological models and taking into account standard dosages.”

This new approach is likely compliant with EU law.  Exports are in principle allowed, and the authority gives clear public health criteria that could be a ground for refusal.  In general terms, three working days also appears a reasonable time-period, unless the planned export is itself particularly urgent given the global health emergency.

3. Exports within the EEA under the Decision of 8 April 2020

Article 3(2) has been redrafted to reflect that exports to the EEA are in principle permitted.  Other than that, the requirements are identical as under the old Decision: prior notification is required, and the medicine or raw material must be destined for supply or administration in the EEA member state of destination.

European Commission Publishes Exceptional Antitrust Guidance for Undertakings Collaborating to Address the Shortage of Essential Products and Services during COVID-19

On 8 April 2020, the European Commission published its Communication on the “Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak” (the “Framework“).

The Commission recognizes that supply chains have been severely disrupted due to COVID-19, combined with “an asymmetric demand shock caused by either an abrupt decline in consumer demand for certain products and services or a steep rise in demand for other products and services”, notably in the health sector.  The duration and intensity of the shock is unknown.

These exceptional circumstances “may trigger the need for undertakings to cooperate with each other in order to overcome or at least mitigate the effects of the crisis to the ultimate benefit of citizens” (para 3).

The purpose of the Framework is to:

(i) explain the main criteria that the Commission will follow when assessing possible cooperation projects between undertakings aimed at addressing the shortage of essential products and services during the COVID-19 outbreak;

(ii) describe the exceptional procedure that the Commission has set up to provide, where appropriate, ad hoc ‘comfort letters’ to undertakings in relation to specific cooperation projects.

The Framework applies to forms of cooperation between undertakings aimed at ensuring the supply and adequate distribution of essential scarce medicinal products and medical equipment (presumably not only medical devices but also personal protective equipment), as well as related services, during the pandemic.  Undertakings currently active in the health sector can benefit from it, but so can those active in other sectors that are retooling to focus on scare products.  The Framework may be amended or supplemented to cover other forms of cooperation.

Main criteria for the competition assessment of cooperation projects

The Framework reiterates that certain practices do not raise competition concerns in any circumstances, provided that they are subject to sufficient safeguards.  For example, a trade association may share aggregated supply gap information with its members, and it may request its members, on an individual basis and without sharing that information with competitors, to indicate whether they can fill the supply gap to meet demand (either through existing stocks or increase of production).

However, the adaptation of production, stock management, and distribution may require exchanges of commercially sensitive information and certain coordination (e.g., who produces which medicines to help ensure an adequate supply of all necessary medicines).  Such coordination between undertakings is in normal circumstances problematic under the competition rules.  Nevertheless, in the current exceptional circumstances, such measures would “not be problematic” under the competition rules or – in view of the emergency situation and temporary nature – they would “not give rise to an enforcement priority” (para 15) for the Commission, to the extent that they are:

(i) designed and objectively necessary to actually increase output in the most efficient way to address or avoid a shortage of supply of essential products or services, such as those that are used to treat COVID-19 patients;

(ii) temporary in nature, meaning that they last only as long there is a risk of shortage or in any event are limited to the duration of the COVID-19 outbreak; and

(iii) not exceeding what is strictly necessary to achieve the objective of addressing or avoiding the shortage of supply.

The Framework also provides that “undertakings should document all exchanges, and agreements between them and make them available to the Commission on request” (para 15).  Further, the Framework indicates that the fact that a cooperation is encouraged and/or coordinated by a public authority (or carried out within a framework set up by the latter) is also a relevant factor to be taken into account when determining whether or not such cooperation would be problematic under the competition rules or would be an enforcement priority for the Commission.

Finally, the Framework provides that “in the context of an imperative request from public authorities” (para 16) undertakings are allowed to temporarily cooperate in response to urgency situations related to the COVID-19 outbreak.

Exceptional procedure to obtain ad hoc guidance on specific cooperation projects

The Commission has already been providing oral guidance to undertakings during the last weeks with respect to the legality of specific cooperation initiatives.  The Framework explains that the Commission is now also ready, exceptionally and at its own discretion, to provide undertakings with a comfort letter concerning specific cooperation projects that need to be swiftly implemented in order to effectively tackle the COVID-19 outbreak.  Undertakings should write to a dedicated mailbox COMP-COVID-ANTITRUST@ec.europa.eu to seek informal guidance on specific initiatives.

On 8 April 2020, the Commission already issued a first comfort letter to “Medicines for Europe”, a trade association representing the European generic, biosimilar and value added pharmaceutical industries.  The comfort letter addresses a specific voluntary cooperation project among pharmaceutical producers – both members and non-members of the association – aimed at avoiding shortages of critical hospital medicines for the treatment of COVID-19 patients.

The Framework will apply as of 8 April 2020 and remain applicable until withdrawn by the Commission once the underlying exceptional circumstances are no longer present.

European Commission issues Guidelines on the rational supply of medicines to avoid shortages during the COVID-19 crisis, calls for lifting export bans within the EU

As reported previously on this blog, several member states have imposed bans, requisitioned stock and applied various other control measures on medicines and protective equipment (e.g., Belgium, Bulgaria, the Czech Republic, France, the Netherlands, and Poland). On 8 April 2020, the European Commission (“Commission”) issued Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak (“Guidelines”). The Guidelines, which are not formally binding,  request the Member States to lift any export ban for medicines within the EU internal market during the COVID-19 crisis. The Commission suggests a number of alternative measures, such as requesting joint industry efforts to meet demand.

  1. Promotion of solidarity within the EU

The Commission calls on the EU Member States to cease or avoid protectionist measures that may harm the internal market and negatively impact public health. In particular, the Commission requests that Member States (i) lift export bans for medicines within the EU; (ii) avoid national stockpiling by wholesalers or pharmacies (including hospital pharmacies); and (iii) avoid misinformation that leads to consumer stockpiling and improper use of medicines.

In the Guidelines, the Commission refers solely to export bans “within the internal market”, which “are detrimental to the availability of medicines for European patients even when they are legally justifiable” (emphasis added). Interestingly, the Guidelines are entirely silent on Member States’ export bans to third countries. In principle, such export bans ordinarily  cannot be adopted by the Member States, and national export bans driven by shortage concerns are subject to a specific consultation procedures under Regulation 2015/479 to seek to ensure that an export ban is only adopted at EU-wide level. As we reported in a recent client alert, in mid-March, the Commission adopted such measures for protective equipment.

  1. Measures to ensure national supply

As an alternative to export bans, the Guidelines offer a set of recommended actions that Member States may implement to guarantee adequate supply of medicines (including raw materials, intermediates, APIs, substances of human origin such as plasma, and related materials) during the outbreak, namely:

  • Increasing and reorganising production;
  • Ensuring manufacturing continues at full capacity;
  • Implementing regulatory flexibility;
  • Monitoring available stocks at national level;
  • Ensuring necessary support to the wholesale sector;
  • Fully enforcing border “green lanes”;
  • Facilitating air freight and other forms of transport; and
  • Ensuring fair distribution of supply.

These measures have a direct impact on the pharmaceutical industry. For instance, to guarantee manufacturing is not interrupted, the Guidelines recommend that pharmaceutical manufacturing be designated an “essential activity”, allowing its employees (including cross-border workers) to continue traveling to their place of work. Member States should also grant “regulatory flexibility” to the industry. This “flexibility” should take the form of accelerated administrative procedures, such as those for variations to marketing authorisations, procedures for changes in suppliers of APIs, designation of new manufacturing sites, or the extension of expiry dates.

Further, the Guidelines recommend that the Member States, “with the support of the Commission and the European Medicines Agency”, continue to (i) request that actors in the supply chain monitor their stocks and production capacity and share information with authorities (e.g., shortages or disruptions); (ii) request, facilitate and coordinate joint industry efforts to reduce shortages and meet demand; and (iii) implement demand support and procurement initiatives to encourage appropriate supply to patients (e.g., through the EU joint procurement agreement).

Importantly, to allow joint industry cooperation that may otherwise be problematic under EU competition law, the Commission has issued guidance on antitrust issues relating to forms of cooperation aimed at ensuring the supply and adequate distribution of essential scarce products and services during the COVID-19   outbreak.

The Guidelines also recommend that Member States share stock information, such as epidemiological forecasts, with pharmaceutical companies. This is aimed to help them better plan for increased demand and respond to that Member State’s needs. At this moment, some countries require that pharmaceutical companies provide them with stock and manufacturing information (e.g., Spain), but it is unclear whether they share their information with them.

  1. Optimisation of medicines use in hospitals

The Guidelines suggest a number of measures to ensure the optimal use of medicines, most of them relying on alternative routes of supply. For instance, the Guidelines recommend inviting marketing authorisation holders to request the extension of the expiry dates of essential medicines where possible.

The Guidelines also recommend that hospitals adapt their protocols to identify alternative medicines that may be relied on in case of shortages of first-line treatments. In such cases, marketing authorisation holders and wholesalers of alternative products should be informed. Further, Member States should consider using magistral preparations or equivalent veterinary medicines to replace first-line treatments.

In the case of off label use to treat COVID-19 under national early access programmes or in clinical trials, the Guidelines recommend assessing first the needs of patients using these medicines on-label, so as to avoid shortages for that population. The Guidelines state that large, European clinical trials should be given priority over national trials.

  1. Optimisation of sales in community pharmacies

The Guidelines also provide some recommendations for Member States to ensure that patients do not hoard medicines. These include introducing restrictions on sales in community pharmacies and online sales for medicines at risk of shortages or subject to increase demand. For instance, Member States may restrict dispensing to a one-month supply of prescription medicines, or a maximum of one package per customer of non-prescription medicines.

Belgium adopts export ban on certain medicines to non-EEA countries and other measures to avoid COVID-19 shortages

1. Summary

On 1 April 2020, the Belgian Federal Authority for Health and Medicinal Products (“FAMPH”) adopted a Decision to avoid shortages of medicines and raw materials used in the treatment of COVID-19.  It applies for one month from 1 April, renewable.  On 2 April 2020, the authority provided further details in a news post on its website.  The decision implies:

  • An export ban to countries outside the European Economic Area (EEA).  Exceptions must be expressly requested from the FAMPH.
  • Exports to EEA countries are prohibited unless notified beforehand to the FAMPH.
  • Sales quota for wholesalers.
  • Notification and possible reallocation of large stocks.

We briefly explain these measures, and review their lawfulness under EU law.

2. Medicines and raw materials covered

The Decision applies to medicines and raw materials mentioned in the Annexes.  Here are some examples:

  • Annex I: medicines with a single active substance (e.g. intravenous diazepam and lorazepam, fentanyl, epinefrin…);
  • Annex II: medicines with more than one active substance (e.g. lidocainehydrochloride – methylprednisolon…);
  • Annex III: raw materials  (e.g. amoxicillin, chloroquine, morfinehydrochloride…);
  • Annex IV lists medicines with a single active substance for non-intravenous use that are excluded (e.g. diazepam…).

3. Export notification to EEA countries

Article 3 (1st and 2nd indent) of the FAMHP Decision states that it is prohibited to supply medicines to anyone other than wholesalers established in Belgium, entities established in Belgium authorized to distribute medicines, or hospitals established in Belgium.  Similarly, raw materials may only be supplied to wholesalers established in Belgium and entities established in Belgium authorized to distribute medicines.

As an exception to this general principle, supplies to another EEA member state are permitted if (1) the medicine or raw material are intended to be supplied in that member state, and (2) if a notification is sent beforehand to the FAHMP at coronashortages@fagg-afmps.be .  The subject line should read: “Notification export EEA – Name of MA holder – Name of the medicine.”  Under article 126 of the EU-UK withdrawal agreement, for the purposes of the FAMHP Decision, “EEA” should include the UK until 31 December 2020.

Under the current circumstances, the Belgian notification requirement likely complies with EU law given that it allows the FAHMP to monitor product flows.  In this regard, Commission Guidelines of 16 March 2020 on COVID-19 and border management measures state at point 6 that: “Member States should preserve the free circulation of all goods. In particular, they should guarantee the supply chain of essential products such as medicines, medical equipment, essential and perishable food products and livestock. No restriction should be imposed on the circulation of goods in the Single Market, especially (but not limited to) essential, health-related and perishable goods, notably foodstuffs, unless duly justified….”

Close follow-up is required so that the Belgian notification requirement should not – in practice – amount to an intra-EEA export ban.

4. Export ban to non-EEA countries

As mentioned above, the FAMHP contains a general export ban.  For non-EEA countries, the Decision did not provide for a specific procedure to request an exception.  The news post on the FAMHP website of 2 April clarifies this.  It states that an exception can be requested via email to coronashortages@fagg.be. The subject line should read: “Request Export outside the EEA – Name of MA holder – Name of the medicine.”  The country of destination and the quantities should be mentioned.

The export ban is in a tense relationship with EU law.  Article 1 of Regulation 2015/479 states that “[t]he exportation of products from the Union to third countries shall be free, that is to say, they shall not be subject to any quantitative restriction, with the exception of those restrictions which are applied in conformity with this Regulation.”   Therefore, in principle, a Member State should request the European Commission to impose an export authorization at EU-level in order to prevent a shortage of essential products.  In March, the Commission adopted such measures for protective equipment (see our alert here).  When a member state makes such a request, the Commission should decide within 5 working days.  It is unclear whether Belgium has consulted with the European Commission.  Regulation 2015/479 and Belgium’s duty of loyalty to the EU interest (article 4(3) TEU) seem to require this kind of (prior?) consultation.

Article 10 of Regulation 2015/479 does permit Belgium to adopt quantitative restrictions on exports if these are justified on grounds of public health.  Presumably this requires that due to urgency, it is not possible for member state to consult with the European Commission.  Moreover, the export ban requires compliance with the principle of proportionality.  Thus, when a company’s request for non-EEA export is refused, EU law no doubt requires that this is specifically motivated in light of shortages for exactly that product.  A general reference to public health risk is not likely sufficient.

5. Supply quota

Pursuant to article 2 of the FAMHP Decision, manufacturers, wholesalers, wholesalers-distributors must limit sales of medicines and raw materials to an amount equal to the sales of the previous year for that period, increased with a coefficient of maximum 50%. Larger quantities may be supplied on prior notification to the FAHMP.  Wholesalers may receive specific instructions for deliveries from the FAHMP.  These measures too, must be checked for compliance with EU free movement principles on a case-by-case basis.

6. Re-allocation of large quantities of stock

Hospitals and entities authorized to distribute medicines that hold stocks of more than one month of sales volume (or raw materials for the preparation of sales volume of officinal or magistral preparations) must notify this stock to the FAHMP with the goal of possible reallocation.  The sales volume is calculated based on sales of last year for the same period, increased with a coefficient of 50%.

European Commission publishes proposal to postpone the application date of the Medical Device Regulations in response to COVID-19

The European Commission published today its proposal for the European Parliament and the Council to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year.  This publication comes only 9 days after the Commission announced its plans to postpone the MDR (see the InsideEULifeSciences blog post here).  The European Parliament and the Council will have to approve the proposal before the MDR’s current implementation date of 26 May 2020.

The Commission’s legal basis for the postponement are Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (“TFEU”).  This gives the European Parliament and Council the authority to adopt measures that ensure the establishment and functioning of the internal market, and, in particular, set high standards of quality and safety for medicinal products and medical devices.  The Commission also cites the principles of subsidiarity and proportionality, arguing that the measure will ensure a high level of protection of health for patients and users, the smooth functioning of the internal market and avoid potential market disruption:

This Union action is necessary to achieve the objective of the proper implementation and application of [the MDR] by all involved parties, taking into account the magnitude of the current COVID-19 outbreak and the associated public health crisis. The proposed amendment aims to ensure that the intended purpose of [the MDR], that is, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be attained.”

The Commission confirmed that its proposal does not alter the MDR substantively and does not impose any new obligations on manufacturers or other concerned parties.  InsideEULifeSciences will continue to monitor developments and publish updates as they come in.

European Commission publishes Guidance relating to COVID-19 and Public Procurement

The European Commission has recently issued Guidance on using the public procurement framework in the emergency situation related to the COVID-19 crisis.  The Guidance is intended to highlight to Member State authorities the flexibilities available to them under the EU public procurement framework and in particular the Public Procurement Directive 2014/24/EU.  The Guidance highlights the following flexibilities, which authorities may wish to rely on in procuring urgently needed equipment and medicines in response to COVID-19:

  • Authorities may choose to rely on digital tools to facilitate a more effective procurement process;
  • In case of urgency and extreme urgency, the timelines for the open and restricted procedures may be significantly shortened; and
  • Authorities may rely on the negotiated procedure without publication allowing them to negotiate directly with one or more potential suppliers.

The last point is particularly relevant.  The negotiated procedure without publication can ordinarily only be relied upon in certain very narrow circumstances.  One of these circumstances includes “reasons of extreme urgency brought about by events unforeseeable by the contracting authority”, which makes compliance with the deadlines for other procedures impossible.  In the Guidance, the Commission acknowledges:

“The specific needs for hospitals, and other health institutions to provide treatment, personal protection equipment, ventilators, additional beds, and additional intensive care and hospital infrastructure, including all the technical equipment could, certainly, not be foreseen and planned in advance, and thus constitute an unforeseeable event for the contracting authorities.”

Similarly, the Commission also accepts that the need has to be met as soon as possible, so that even the shorter timelines for the open or restricted procedures may be unsuitable.  However, the Commission also notes that this would need to be assessed on a case-by-case basis and that urgency could not be invoked in the procurement ultimately takes longer than if any of the other procedures were followed.  Finally, the Guidance also makes clear that this procedure should only be used to meet immediate needs and to “cover the gaps until more stable solutions can be found.

The Guidance addressed to Member State authorities follows after 25 Member States had participated in a joint procurement for personal protective equipment by the European Commission and for which bids were received by the end of March (see here).

The Italian Medicines Agency publishes Guidance on the management of clinical trials in Italy during the COVID-19 emergency

On March 12, 2020, the Italian Medicines Agency (“AIFA”) has provided guidance on the management of clinical trials due to the COVID-19 emergency.  The Guidance, which is addressed to CROs, Sponsors and non-profit organizations involved in clinical trials, allows for some derogations to support them face the criticalities.  The Guidance is intended to ensure that activities related to clinical trials may still continue, despite the current situation.

The Guidance covers all the phases of clinical trials, i.e., submission of authorization requests of clinical trials; Ethics Committees’ evaluation; management of clinical trials outside investigational sites.  The Guidance also provides some exemptions from the current EU and Italian legislation, i.e., management of the Investigational Medicinal Product; closure of a clinical trial site; clinical tests; clinical trial monitoring; reimbursement of exceptional expenses; possibility for Sponsors to enter into agreements directly with specialized agencies to carry out activities related to the management of patients.  We provide further details below.

Submission of authorization requests of clinical trials

The Guidance provides for the postponement of submission of paper documentation and CD-ROM concerning authorization requests of clinical trials and substantial amendments.  It also allows the submission of authorization requests by e-mail if the trials concern the treatment of Covid-19.

Ethics Committees’ evaluations of clinical trials/substantial amendments

Ethics Committees may arrange their meetings via web-conferences and other telematics ways.

Management of clinical trials outside investigational sites

The Guidance allows conducting clinical trial activities outside of investigational sites when this is necessary to limit the risk of coronavirus infection.  In this case, Sponsors must notify a substantial amendment for immediate implementation to the competent Ethics Committee, outlining the urgency of the situation.  Furthermore, Sponsors and CROs must prepare a risk evaluation plan and implement an action plan with the purpose to minimize contacts between patients and the staff, and to avoid to overload healthcare facilities.

As we mentioned above, the Guidance also provides some exemptions from the current EU and Italian legislation.

  1. Investigational Medicinal Product. Where possible, it may be useful to supply an amount of the Investigational Medicinal Product for a period of time longer than is normally estimated.  Under these circumstances, deliveries of the medicinal product may be arranged directly to patients, upon indications of the director of the hospital pharmacy and the principal investigator.
  1. Closure of a clinical trial site. If a site is closed to the public for COVID-19 containment measures, it should be first assessed whether the clinical trial staff is able to guarantee the continuity of the trial.  If it is not the case, the trial should be temporarily suspended or patients should be transferred to the nearest active clinical trial site.
  1. Clinical tests. Hematological tests should be carried out in public health facilities.  However, private sites should be chosen only when it is the only possibility for patients’ protection.
  1. Clinical trial monitoring. Telephone contacts or videoconferences with the trial site staff are allowed provided that these are described in specific Standard Operating Procedures (“POS”) by the Sponsor/CRO and approved by the Data Protection Officer of the trial site.
  1. Exceptional expenses reimbursement. Sponsors are allowed to directly reimburse patients, in case they incur additional expenses for the implementation of urgent measures.
  1. Possibility for Sponsors to sign directly with specialized agencies to carry out activities related to the management of patients. Interestingly, in derogation from FAQ 11 of EMA’s “Q&A: Good clinical practice (GCP)”, Sponsors may enter into service agreements directly with specialized agencies or companies, g., home nursing services, to carry out activities related to the management of patients.  Such activities must be carried out under the responsibility of the principal investigator.

AIFA makes clear that the Guidance remains valid until further notice.

Finally, it should be noted that on March 20, 2020, the European Medicines Agency published guidance on the management of clinical trials due to the current healthcare emergency.  The EMA invites all the sponsors and investigators to consult the specific national legislation and guidance in place and to use them to complete the EMA’s guidance or, for specific matters, they make take priority over the EMA’s guidance.

European Commission plans to postpone the application date of the Medical Device Regulations in response to COVID-19

The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year.  This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding to the COVID-19 outbreak.  According to the Commission spokesman, the goal is:

“to submit this proposal early April and we call on Parliament and on Council to adopt it quickly, as the deadline for entry into force is at the end of May.”

This will be welcome news to all manufacturers of medical devices intended for the EU market, as well as other economic operators in the supply chain.  The postponement of the implementation date will allow companies to deploy resources to address the current pandemic and will give them extra time to become MDR-compliant.

InsideEULifeSciences will continue to monitor developments and publish updates as they come in.