The VBB Alert covers Covid-19 related aspects of competition law at both the European Union and Member State levels, with a special focus on state aid measures in Belgium, Germany, Italy, Luxembourg, the Netherlands and the UK.COVID-19 Special Alerts │ 21 August 2020
The VBB Alert covers Covid-19 related aspects of competition law at both the European Union and Member State levels, with a special focus on state aid measures in Belgium, France, Germany, Italy, Luxembourg, the Netherlands and the UK.Covid-19 Special Alert │ 04 June 2020
The VBB Alert covers Covid-19 related aspects of competition law at both the European Union and Member State levels, with a special focus on state aid measures in Belgium, France, Germany, the Netherlands, Spain as well as the UK.Covid-19 Special Alert │ 04 May 2020
The VBB Alert covers Covid-19 related aspects of competition law at both the European Union and Member State levels, with a special focus on state aid measures in Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Spain and the United Kingdom.Covid-19 Special Alerts │ 21 April 2020
On 6 April 2020, the Italian Government adopted a Law Decree (so-called “ Decreto Liquidità ”) laying down additional measures to support companies negatively affected by the economic consequences of the Covid-19 outbreak. These measures aim at alleviating the devastating effects of the outbreak on the Italian economy. However, it would appear that some of the measures may raise issues in light of EU and WTO law.
Since the final text of the Law Decree has not yet been published in the Italian Official Journal, this flash alert is based on the measures as described in the press release issued by the Italian Government on 6 April 2020.Special Alert
In the wake of the global Covid-19 outbreak and its devastating repercussions for the business community, Member States have announced that they will adopt all necessary measures to help those in difficulty. In this context, for instance, the Italian government has adopted incentives and other economic support measures amounting to 25 billion EUR. Other Member States are expected to take similar measures in the near future.
Please click below to read the memorandum.Download Memorandum
On 19 March 2020, the Commission adopted a Temporary Framework for State aid measures to support the economy in the current COVID-19 outbreak (the “Covid-19 Temporary Framework”). This Temporary Framework complements the Communication on a Coordinated economic response to the COVID-19 outbreak adopted on 13 March 2020.
The Covid-19 Temporary Framework outlines the conditions that the Commission will apply when analysing aid granted by Member States under Article 107(3)(b) Treaty on the Functioning of the European Union (“TFEU”).
As a general rule, Member States must notify the planned State aid to the Commission and demonstrate that it is necessary, appropriate and proportionate to remedy a serious disturbance in the economy of the Member State concerned, and that it complies with all the conditions set out in the Covid-19 Temporary Framework.
Please click below to read the Covid-19 Temporary Framework.Download Memorandum
Belgian Business Law
Covid-19, also known as the coronavirus, continues to spread across the globe, including in Belgium. The Belgian authorities have imposed a lock down on all private individuals and enterprises as from 18 March 2020 until 4 April 2020 (the Lock Down Period), but this Lock Down Period will in all likelihood be extended.
Measures taken by the authorities for the duration of the Lock Down Period include the closure of non-food shops, restaurants, bars and other retail outlets, employees being instructed to work from home to the extent possible, travel restrictions and the partial closing of borders for persons except in case of essential travel (the Measures).
As a result of the Measures, certain agreements cannot be performed anymore, such as commercial lease agreements and contracts for the supply of goods or services.
What is the effect of the Measures on a contracting party’s legal obligation to perform the agreement? For example, does it have to pay the rent for its closed shop/restaurant? Does it need to pay the supplier for the food delivered which will perish because of a restaurant closure? Does the supplier need to continue performing its suppy agreement?.
For any question regarding employment law, we refer to our FAQ available here.
This FAQ document answers a series of business questions that our clients have raised in this respectView FAQs
Corporate M&A and Restructuring
On 20 December 2020, Belgian Parliament adopted a new law setting out various temporary measures and structural provisions to mitigate the impact of the Covid-19 crisis (the Law). The Law includes a statutory moratorium applicable from 24 December 2020 until 31 January 2021 (included) for enterprises that are or were forced to close in application of the Ministerial Decree of 1 November 2020 setting out emergency measures to limit the spread of the Covid-19 (the Moratorium).
In summary, the Moratorium provides that enterprises are protected against (i) bankruptcy and judicial dissolution, (ii) attachment and enforcement measures and (iii) termination of existing contracts due to non-payment. In addition, payment periods included in a homologated judicial reorganisation plan approved before or after 24 December 2020 are extended by the duration of the suspension with a corresponding extension of a maximum period of five years for the implementation of the reorganisation plan.
Unlike the previous moratorium decided upon in March 2020 and which applied until mid-June 2020, the Moratorium only applies to enterprises that are or were forced to close due to the governmental restrictions and whose continuity is threatened by these measures. The Moratorium will automatically end on 31 January 2021 unless extended by the Belgian Government.
On 17 June 2020, the temporal scope of the Royal Decree concerning the temporary suspension, for the benefit of enterprises, of enforcement measures and other measures during the Covid-19 crisis (the Decree) has ended. The Belgian Federal Government had already extended the original temporal scope of the Decree from 17 May 2020 until 17 June 2020, but has not repeated this.
The Decree was adopted on 24 April 2020 and granted an automatic moratorium during which enterprises were protected against (i) bankruptcy, judicial dissolution and transfers under judicial authority, (ii) attachments and enforcement measures, and (iii) termination of existing contracts due to non-payment. In addition, new credit lines provided during the moratorium and the security interests or acts that were implemented in execution of such new credit lines, were protected against subsequent bankruptcy.
On 13 May 2020, the Belgian Federal Government extended the temporal scope of the Royal Decree on temporary protection measures for enterprises (the Decree) from 17 May 2020 until 17 June 2020.
The Decree was adopted on 24 April 2020 and grants an automatic moratorium during which enterprises are protected against (i) bankruptcy, judicial dissolution and transfers under judicial authority, (ii) attachments and enforcement measures, and (iii) termination of existing contracts due to non-payment. In addition, new credit lines provided during the moratorium and the security interests or acts that are implemented in execution of such new credit lines, will be protected against subsequent bankruptcy.
The automatic moratorium period initially applied until 17 May 2020, but has now been extended until (and including) 17 June 2020.
More information on the temporary protection measures can be found in our memorandum of 27 April 2020.Memorandum of 27 April 2020
On 28 April 2020, the Belgian Federal Government extended the applicability of the special regime allowing legal entities to organise general meetings and board of directors’ meetings in more flexible ways until 30 June 2020 (instead of 3 May 2020).
Earlier this month, on 9 April 2020, the Belgian Federal Government had adopted a royal decree granting more flexibility to (i) all legal entities governed by the Belgian Companies and Associations’ Code (companies and associations), (ii) all legal entities that acquired legal personality through a specific law and (iii) contractual Institutions for Collective Investment to organise general meetings and board of directors’ meetings (the Decree) in compliance with the confinement measures.
The Decree allows legal entities to organise the general meeting behind closed doors with a remote voting procedure and/or voting procedure by proxy or to postpone the meeting. In addition, the board of directors’ meetings may also be held by telephone or video conference or decisions may be adopted by unanimous written resolutions. The Decree was initially applicable to meetings that should have been held or are to be held between 1 March 2020 and 3 May 2020, or in relation to which the convocation notice was or is to be sent or published between those dates.
The temporal scope of this flexible regime has now been extended and applies to general meetings and board of directors’ meetings that should have been held or are to be held, or have been or should be convened, between 1 March 2020 and 30 June 2020.
The extension will, however, not affect the already extended deadlines in relation to the adoption of the annual board report and the approval and filing of the annual accounts. Pursuant to the Decree, the annual general meeting may be postponed for up to ten weeks as from the statutory deadline. This means that legal entities whose financial year ended on 31 December 2019 may postpone the approval of the annual accounts until 8 September 2020 and must file the approved annual accounts with the National Bank of Belgium by 8 October 2020 at the latest.
More information on the flexible regime for general meetings and board meetings can be found in our memorandum of 10 April 2020.
On 24 April 2020, the Belgian Federal Government has adopted a Royal Decree concerning the temporary suspension, for the benefit of enterprises, of enforcement measures and other measures during the Covid-19 crisis (the Decree).
In summary, the Decree grants an automatic moratorium from 24 April 2020 until 17 May 2020 (subject to prolongation), during which enterprises are protected against (i) bankruptcy and judicial dissolution, (ii) attachments and enforcement measures; and (iii) termination of existing contracts due to non-payment. In addition, new credit lines provided during the moratorium and the security interests or acts that are implemented in execution of such new credit lines, will be protected against subsequent bankruptcy.
With decades of expertise in strategic negotiations for companies facing financial difficulties and in judicial reorganisations, our M&A and restructuring team will be happy to assist you in identifying solutions.
For more detailed information, please see our memo attached.
The current confinement measures make it, in principle, impossible for shareholders and directors to convene physically. Therefore, the Belgian Federal Government adopted, on 9 April 2020, a royal decree allowing (i) all legal entities governed by the Belgian Companies and Associations’ Code (companies and associations), (ii) all legal entities that acquired legal personality through a specific law and (iii) contractual Institutions for Collective Investment to organise general meetings and board of directors’ meetings in more flexible ways (the Decree).
The Decree applies regardless of the rules contained in the articles of association. It applies to meetings that should have been held or are to be held between 1 March 2020 and 3 May 2020, or in relation to which the convocation notice was or is to be sent or published between those dates.
In addition, the deadlines for approving and filing the annual accounts have also been prolonged.
For more detailed information, please see our memo attached.Memorandum
As is the case in many other European countries, the Belgian Federal Government is trying to further mitigate the negative effects of the Covid-19 crisis on Belgian companies and associations in light of the current confinement measures.
Amongst other initiatives, it is preparing a draft act providing that shareholders’ meetings which must be convened before 19 April 2020, may be held either electronically or in writing (even if this is not provided for by the articles of association). The draft act also provides that the deadline to hold the upcoming annual shareholders’ meeting will be extended with ten weeks. Since the annual shareholders’ meetings of Belgian companies and associations with a financial year ending on 31 December must be held by 30 June at the latest, the deadline will be extended to 8 September 2020.
Further, until 19 April 2020, the (board of) directors may adopt decisions through unanimous written resolutions “under all circumstances”, i.e. even if the articles of association do not provide for the possibility to have written resolutions. Until that date, the (board of) directors may also deliberate and decide through electronic communications.
These dates may still change in the weeks to come, depending on further confinement measures taken by the Belgian Federal Government.
Over the last few weeks, virtually all M&A transactions have come to a halt. In some instances, the parties opted to await the impact of the crisis. In other instances, the financing banks withdrew from the deal, or were only willing to finance at significantly more onerous conditions.
It is beyond doubt that M&A activity will be down significantly during the coming few months. However, it is also the expectation that the current crisis will create a host of possibilities as from the second half of the year, if not earlier. Whatever the outcome, the M&A market will likely be very different at the other end of this crisis, be it in terms of acquisition structures, multiples (how to calculate, for instance, normalised working capital or EBITDAs in the current circumstances), financing terms and leveraging, and transaction dynamics in general.
With decades of expertise in strategic negotiations for companies in difficulties and in judicial reorganisations, our corporate M&A team will be happy to assist you in identifying solutions. In attachment, we provide an overview of legal and strategic concerns that may be useful from a corporate and finance perspective.
On 21 April 2020, the European Data Protection Board (the EDPB) published guidelines on the use of location data and contact tracing tools in the context of the Covid-19 outbreak (the Guidelines). The Guidelines discuss how to use location data and build contact tracing apps in compliance with EU data protection and ePrivacy rules. In addition, the EDPB provides a guide setting out an itemised list for developing contact tracing tools in the fight against Covid-19.Memorandum
On 21 April 2020, the European Data Protection Board (EDPB) adopted guidelines for the processing of personal data concerning health for the purposes of scientific research in the fight against Covid-19. One of a myriad of guidance documents published by the EDPB in relation to the ongoing Covid-19 crisis, these guidelines provide guidance to public and private organisations on how to reconcile scientific research with data protection requirements. In particular, the guidelines discuss the legal basis for such activity, the implementation of adequate safeguards, and the exercise of data subjects’ rights.Memorandum
The eHealth Network, a voluntary network of Member States’ authorities responsible for eHealth, published a common EU Toolbox for Member States on Mobile applications to support contact tracing in the EU’s fight against COVID-19. It did so with the help of the European Commission. The toolbox provides guidance for the Member States and explains how mobile applications can support contact tracing in the EU’s fight against COVID-19. The EU Toolbox was complemented by the Commission’s Guidance on apps supporting the fight against COVID-19 pandemic in relation to data protection.
The attached note which our office prepared explains why and how.
On 6 April 2020, the European Data Protection Supervisor (EDPS), the European regulator overseeing data protection compliance at the EU institutions, urgently asked Member States to adopt a harmonised approach for the protection of personal data when tackling the COVID-19 crisis. The EDPS also called for a pan-European model “COVID-19 mobile application”.
The EDPS emphasises that EU data protection rules, including the General Data Protection Regulation, do not stand in the way of any necessary action to face the challenges posed by Covid-19. Instead, the EDPS maintains that these rules provide the framework for tackling the problems while mitigating any risks of eroding the fundamental rights of individuals. According to the EDPS, Member States should not turn to national tools only: “[i]f we are so connected with each other, we will not be able to solve it with national tools only. The more European will our answer be the better results we will gain”.
The EDPS confirms that, given the urgency and nature of the crisis, exceptional measures can be justified, but these should observe safeguards designed to prevent a lasting impact on fundamental rights and freedoms. As a result, exceptional measures should (i) be temporary; (ii) be limited to the specific purpose of fighting the COVID-19 crisis; (iii) restrict access to the data; and (iv) contain rules governing the fate of the data after the crisis.
Various Member States have relied on mobile applications or telecommunications data to combat the spreading of the virus with varying degrees of impact on the protection of the individual’s fundamental rights. An example in point is whether the telecommunications and location data used are truly anonymous. The EDPS notes that the use of “temporary broadcast identifiers and Bluetooth technology” is a useful means for contact tracing while respecting privacy. According to the EDPS, a pan-European model “COVID-19 mobile application” would ensure data protection by design from the start.
The EDPS’ statement can be found here.
Please do not hesitate to contact us should you have any questions on this matter.COVID-19 | European Data Protection Supervisor (EDPS) urgently asks Member States to adopt harmonised approach for protection of personal data
The outbreak of the new Corona virus COVID-19 has caused various emergencies with novel challenges for many organisations collecting and processing personal data, such as:
• Employers monitor employees working from home; request employees and visitors to report risk factors such as travelling or exposure to people with flu-like symptoms; may need to report that an employee is infected with COVID-19 to other employees;
• physicians and pharmaceutical companies may wish to use data to investigate new treatments;
• authorities enforce lockdown measures by video cameras and tracking phones; and
• health authorities need detailed test results and other health data to map virus spreads and keep detailed statistics.
European and Belgian data protection authorities have provided guidance on the application of data protection rules to these novel challenges. “Data protection rules (such as the GDPR) do not hinder measures taken in the fight against the coronavirus pandemic”, writes the European Data Protection Board (EDPB).
While the urgency of the situation may justify measures that go further than would be normally allowed, the EDPB warns that these measures should be proportionate and limited to what is necessary: an “[e]mergency is a legal condition which may legitimise restrictions of freedoms provided these restrictions are proportionate and limited to the emergency period”.
In addition, the Belgian data protection authority (Gegevensbeschermingsautoriteit / autorité de protection des données – the DPA) has published a Q&A on COVID-19 and the processing of personal data in the workplace. The DPA is of the opinion that employers should only process health data if required by public authorities. In other cases, health data of employees should always be processed by the occupational physician.
The DPA sets out a short Q&A in which it explains, among other matters, that measuring body temperature does not constitute a processing of personal data as long as it is not recorded. Nevertheless, the DPA reiterates that such measures should be implemented in accordance with applicable employment rules.
The full statement of the EDPB can be consulted here.
The Q&A of the Belgian DPA is available in Dutch and in French.
On 17 July 2020, a Royal Decree was published in the Belgian Official Journal (Koninklijk besluit tot verlenging van de maatregelen genomen op vlak van werkloosheid in het kader van de strijd tegen de verspreiding van het coronavirus Covid-19 / Arrêté royal prolongeant les mesures prises en matière de chômage dans le cadre de la lutte contre la propagation du coronavirus Covid-19) in order to extend the possibility to apply temporary unemployment due to Covid-19 force majeure (i) until 31 August 2020 included for all companies and (ii) until 31 December 2020 included for “companies and sectors particularly affected by the corona crisis”, namely:
§ companies which during the second quarter of 2020 experienced a number of days of temporary unemployment due to economic reasons and to Covid-19 force majeure of at least 20% of the total number of days reported to the National Social Security Office (Rijksdienst voor Sociale Zekerheid / Office National de Sécurité Sociale). The days reported for unpaid leave, sick leave, maternity leave and paternity leave are not taken into account; and
§ the sectors whose “economic activity and employment have decreased significantly as a result of emergency measures adopted by the Minister of the Interior to limit the spread of the Covid-19 coronavirus”. The adoption of a decree by the Minister of Employment is expected in order to clarify the sectors concerned.
More information on the Extension of the possibility to apply temporary unemployment due to Covid-19 force majeure can be found in the attached note.Extension of the possibility to apply temporary unemployment due to Covid-19 force majeure
On 22 June 2020, the law aiming to suspend notice periods notified by the employer before or during temporary unemployment due to Covid-19 force majeure (Wet tot opschorting van de opzeggingstermijn voor ontslagen gegeven voor of tijdens de periode van tijdelijke schorsing van de uitvoering van de arbeidsovereenkomst omwille van overmacht ingevolge de COVID-19-crisis / Loi visant à suspendre les délais de préavis des congés donnés avant ou durant la période de suspension temporaire de l’exécution du contrat de travail pour cause de force majeure en raison de la crise du COVID-19) was published in the Belgian Official Journal (the Law).
Pursuant to the current applicable legal framework, notice periods – when served by the employer – are suspended (extended) by periods of absence such as sick leave, temporary unemployment for economical reasons, etc. Notice periods are, however, not suspended in case of temporary unemployment due to force majeure.
More information on the suspension of the notice period during temporary unemployment due to Covid-19 force majeure can be found in the attached note.
On 28 April 2020, an Emergency Powers Decree No. 14 (the Decree) was published in the Belgian Official Journal in order to guarantee an adequate work organisation during the Covid-19 crisis. In particular, the Decree adopts several employment-law related measures in order to address staff shortages in certain essential and vital sectors.
This newsflash provides an overview of the most important measures which may be relevant for certain employers.Newsflash
The Government recently decided that all employers facing economic difficulties due to the Covid-19 crisis may rely on the regime of temporary unemployment due to force majeure for their employees (See, our previous newsflashes of 10 March and 19 March 2020.
In addition, the regime has been simplified so that the employer only needs to submit an electronic declaration to the authorities and the employees subsequently must fill out their personal details via an online form in order to receive payment of the unemployment benefits.
Under this regime the employees are entitled to (i) unemployment benefits capped at 70% of their normal gross monthly salary (which in turn is capped at EUR 2,754.76 gross), and (ii) a supplement of EUR 5.63 paid by the Belgian authorities per unemployment day.
Many employers have availed themselves of his regime but many practical questions remain, such as:
• Can the employer supplement the unemployment benefits of the employees and are such supplements subject to social security contributions?
• Is the employer legally required to pay the bank holidays which fall within the period of temporary unemployment?
• What if an employee becomes ill during a period of temporary unemployment? Is he entitled to a guaranteed salary during such period of illness?
• Will the simplified regime of temporary unemployment due to force majeure be extended automatically if the lockdown measures of the Government are extended as well?
• Can an employer oblige his employees to take up all their vacation days prior to the application of the regime of temporary unemployment?
VBB would be pleased to assist you with any questions related to the regime of temporary unemployment due to force majeure or any other questions you may have related to the employment law measures that the Government has adopted in the framework of the Covid-19 crisis.
Feel free to reach out to us by clicking on the following link: Covid19HelplineUnemployment due to force majeure | Practical questions
Referring to our newsflash dated 10 March 2020, you will find below an overview of the complementary employment-related measures which have been put in place following the lockdown measures within the framework of Covid-19 as announced by the Belgian government on 12 and 17 March 2020.
These measures are subject to continuous changes. The current newsflash provides an overview of the situation to date and we will keep you informed about any important developments in this respect.
Click below to read the complementary employment-related measuresComplementary employment-related measures
The covid-19 virus, also known as the coronavirus, continues to spread across the globe. Recently the virus arrived in Belgium as well, with the number of confirmed cases expected to rise exponentially. Employers should be prepared to take measures to ensure a healthy and safe workplace for their employees.
This FAQ document answers a series of questions that have been raised by our clients - employers in Belgium.View FAQs
In what is the result of both human ingenuity and extremely hard work by many in academe, industry and regulatory bodies, the European Medicines Agency (EMA) issued today the recommendation that Covid-19 Vaccine AstraZeneca® should be given a conditional marketing authorisation to prevent coronavirus disease 2019 in people 18 years of age and older. The authorisation by the European Commission is expected to follow shortly (see, attached press release).
Covid-19 Vaccine AstraZeneca® will be the third vaccine to be approved in the European Union to tackle Covid-19 following Comirnaty® (see, Van Bael & Bellis Life Sciences News Alert of 21 December 2020) and Covid-19 Vaccine Moderna® (see, Van Bael & Bellis Life Sciences News Alert of 6 January 2021).
The safety of the vaccine was demonstrated by the outcome of four clinical trials conducted around the world. Its efficacy relies on the results of two studies carried out in Brazil and the United Kingdom. They showed a 59.5% reduction in the number of symptomatic Covid-19 cases in persons given the vaccine when compared with a control group. The vaccine thus almost reached the critical 60% efficacy threshold.
Importantly, EMA allowed the vaccine to be used for persons over 55 years old, thus countering doubts over the vaccine’s efficacy in older persons. While there are at present not enough results in the group of study participants over 55 years to yield a reliable figure for how well the vaccine will function in that age bracket, protection is still expected. To reach that conclusion, EMA considered the immune response observed in this group as well as experience gathered with other vaccines. Over time, the ongoing studies are expected to give further information in that regard.
The marketing authorisation awarded to Covid-19 Vaccine AstraZeneca® will be conditional in that the marketing authorisation holder will be required to continue providing results from ongoing studies and thus offer confirmation that the benefits outweigh the risks. Such risks are inherent in the fact that not all data are available at this time. AstraZeneca will also carry out studies that focus on the pharmaceutical quality of the vaccine following the expansion of the manufacturing operations.
This distinctly positive development stands in sharp contrast with a bitter, very public and seemingly unnecessary fight between AstraZeneca and the European Commission over alleged supply obligations.
The European Medicines Agency (EMA) issued today its recommendation that the European Commission (the Commission) should grant a conditional marketing authorisation for the vaccine Covid-19 Vaccine Moderna®, a medicine developed by Moderna which will be indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older (see, attached press release). The Commission is expected to give its approval shortly, possibly still today, paving the way for an expansion of existing vaccination programmes in the European Union.
The recommendation follows a similar recommendation given on 21 December 2020 for Comirnaty®, a vaccine developed by BioNTech and Pfizer (see, Van Bael & Bellis Life Sciences News Alert of 21 December 2020). As is the case for Comirnaty®, Covid-19 Vaccine Moderna® contains a molecule called messenger ribonucleic acid (mRNA) which harbours instructions for making the spike protein which is characteristic of the SARS-CoV-2 virus and allows the virus to enter the human body’s cells. The vaccine thus causes the recipient’s body to recognise and produce the spike protein temporarily which, in turn, will activate the person’s immune system and cause it to produce antibodies and activate white blood cells to attack it. The person’s immune system is thus readied for an attack with the genuine SARS-CoV-2 virus and defend the body against it.
The EMA made its recommendation on the basis of placebo-controlled clinical trial data involving 30,000 people. Efficacy was calculated in around 28,000 persons and showed a significant 94.1% reduction in the number of symptomatic Covid-19 cases in persons who were given the vaccine compared with persons from the control group who received a dummy injection. These strong results applied irrespective of pre-existing risk-enhancing conditions such as chronic lung disease, heart disease or diabetes and regardless of age (18 and up), gender, race or ethnicity.
The marketing authorisation awarded to Covid-19 Vaccine Moderna® will be conditional in that the marketing authorisation holder will be required to continue providing results from the ongoing main trial which is scheduled to last two years. Additional trials will seek to gain fresh information regarding the length of protection afforded, the level of protection created against severe Covid-19 infections and the degree of protection established for the benefit of specific groups, including immunocompromised patients, children, and pregnant women. Further research will also focus on the vaccine’s ability to prevent asymptomatic cases. Other checks will result from the application of the EU’s safety monitoring plan for Covid-19 vaccines and from the risk management plan for Covid-19 Vaccine Moderna®.
The European Medicines Agency (EMA) issued today its recommendation that the European Commission (the Commission) should grant a conditional marketing authorisation for the vaccine Comirnaty®, a medicine developed jointly by BioNTech and Pfizer which will be indicated for the prevention of the Coronavirus disease 2019 in persons 16 years of age or older (see, attached press release). The Commission is expected to give its approval within days, paving the way for the first vaccinations in some Member States as soon as 27 December 2020.
Comirnaty® contains a molecule called messenger ribonucleic acid (mRNA) which harbours instructions for making the spike protein which is characteristic of the SARS-CoV-2 virus and allows the virus to enter the human body’s cells. The vaccine thus causes the recipient’s body to recognise and produce the spike protein temporarily which, in turn, will activate the person’s immune system and cause it to produce antibodies and activate white blood cells to attack it. The person’s immune system is thus readied for an attack with the genuine SARS-CoV-2 virus and defend the body against it.
The EMA made its recommendation on the back of strong placebo-controlled clinical trial data involving 44,000 people. Efficacy was calculated in over 36,000 persons and showed an impressive 95% reduction in the number of symptomatic Covid-19 cases in persons who were given the vaccine compared with persons from the control group who received a dummy injection. These strong results applied across the board, irrespective of preexisting risk-enhancing conditions such as asthma or diabetes and regardless of age (16 and up), gender, race or ethnicity.
The marketing authorisation awarded to Comirnaty® will be conditional in that the marketing authorisation holder will be required to continue providing results from the ongoing main trial which is scheduled to last two years. Additional trials will complement the principal trial. Further checks will result from the application of the EU’s safety monitoring plan for Covid-19 vaccines and from the risk management plan for Comirnaty® which contains information about the vaccine’s safety, the collection of further information and ways to minimise potential risks.
On 24 November 2020, European Commission President von der Leyen released a statement announcing that she would approve a sixth agreement with a supplier of a potential Covid-19 vaccine (see, attachment). The Commission’s new contract partner is Moderna. Under the agreement, the Commission will have the right to buy up to 160 million doses of the vaccine, if and when that product obtains a marketing authorisation from the European Medicines Agency.
In recent days, the Commission announced similar deals with CureVac (see, Van Bael & Bellis Life Sciences News Alert of 17 November 2020) and with BioNTech and Pfizer (see, Van Bael & Bellis Life Sciences News Alert of 12 November 2020). The Commission President suggested that a seventh agreement is being negotiated which paves the way for the creation in Europe of “one of the most comprehensive COVID-19 vaccine portfolios in the world”.
On 16 November 2020, European Commission President von der Leyen released a statement announcing that she would sanction yet another agreement with a supplier of a potential Covid-19 vaccine (see, attachment). This time around, vaccine supplier CureVac will be the Commission’s contract partner and the impending transaction is the fifth of its kind. Under the agreement, the Commission will have the right to procure up to 405 million doses of the vaccine, if and when that product obtains a marketing authorisation from the European Medicines Agency.
Only a few days ago, the Commission announced a similar deal with BioNTech and Pfizer (see, Van Bael & Bellis Life Sciences News Alert of 12 November 2020) and a sixth agreement with Moderna is in the works. Moderna just published, like BioNTech and Pfizer earlier, very encouraging interim test results.
For its part, CureVac had already secured funding from the Commission and the European Investment Bank in order to, among other objectives, develop its Covid-19 vaccine which relies on optimised messenger RNA, the technology also at the basis of the Covid-19 vaccines of the BioNTech - Pfizer alliance and of Moderna.
As part of its European Vaccines Strategy adopted in June 2020 (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020), the European Commission (the Commission) announced on 11 November 2020 that it approved a fourth agreement providing for access to a potential vaccine against Covid-19 (see, attached press release).
The Commission’s partner for this agreement is an alliance between BioNTech and Pfizer. The parties agreed on an initial purchase of 200 million doses and on an option for the Commission to request a further 100 million doses that will be supplied once the vaccine is demonstrably safe and effective against Covid-19. If it secures a European marketing authorisation, the vaccine will ultimately end up in the hands of interested EU Member States which will have the possibility to donate the vaccine to lower and middle-income countries or redirect it to other European countries.
The vaccine has elicited significant enthusiasm following the publication on 9 November 2020 of initial trial results involving 94 cases. These indicated a vaccine efficacy rate of more than 90% at 7 days after administration of the second dose (the vaccination consists of a 2-dose schedule).
The agreement follows similar deals with AstraZeneca, Sanofi-GSK and Janssen Pharmaceutica (see, Van Bael & Bellis Life Sciences News Alert of 31 August 2020; Van Bael & Bellis Life Sciences News Alert of 21 September 2020; and Van Bael & Bellis Life Sciences News Alert of 12 October 2020). The Commission also concluded exploratory talks with CureVac and Moderna.
On 15 October 2020 the European Commission (the Commission) published a Communication entitled “Preparedness for COVID-19 vaccination strategies and vaccine deployment” (the Communication - see, attachment). The Commission thus seeks to harmonise Member States’ vaccination plans for tackling Covid-19. The plan logically follows from the Commission’s efforts to advance purchase possible Covid-19 vaccines. The Commission has already entered into agreements with three suppliers and three or four more such agreements are in the pipeline (see, Van Bael & Bellis Life Sciences News Alerts of 12 October 2020, 21 September 2020, and 31 August 2020). They all form part of the European Vaccines Strategy which the Commission unveiled at the beginning of the Summer (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020).
In publishing the Communication, the Commission is now making further inroads into sensitive Member State terrain. As the Commission acknowledges, “the responsibility for health policy lies with Member States, and national strategies may differ due to several contributing factors such as different healthcare system capacities, population structure or epidemiological situation” (Communication, p. 9). At the same time, the Commission considers it important “to ensure the coordination of national responses to the pandemic” (Id.).
On that basis, the Communication first identifies key elements “for effective Covid-19 vaccination strategies” and lists associated actions. These involve developing vaccination services, storage and transportation facilities and vaccination registries. Additionally, the Commission stresses the need for clear communication and for tackling head-on misinformation. Significantly, the Commission also contemplates studies of vaccine effectiveness and safety.
The Communication’s second step is to have the Member States identify priority groups for the initial phases of vaccine deployment. The Communication cites such categories and again lists a series of associated preparatory actions.
The Communication concludes with a number of bridging steps towards widespread vaccine availability.Communication
As part of its European Vaccines Strategy adopted in June 2020 (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020), the European Commission (the Commission) announced on 8 October 2020 that it approved a third agreement providing for access to a potential vaccine against Covid-19 (see, attached press release). The Commission’s partner for this new agreement is Janssen Pharmaceutica (Janssen) which has promised to sell vaccines to EU Member States for up to 400 million people. Member States may decide to donate the vaccine to lower and middle income countries or redirect it elsewhere in Europe. The agreement follows similar deals with AstraZeneca and Sanofi-GSK (see, Van Bael & Bellis Life Sciences News Alert of 31 August 2020 and Van Bael & Bellis Life Sciences News Alert of 21 September 2020).
Janssen is developing its Covid-19 vaccine on its AdVac® technology platform which also formed the basis for other existing and potential vaccines against such conditions as Ebola.
As part of its European Vaccines Strategy adopted in June 2020 (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020), the European Commission (the Commission) announced on 18 September 2020 the entry into force of a second agreement providing for access to a potential vaccine against Covid-19 (see, attached press release). The Commission’s partner for the new agreement is Sanofi-GSK which has promised to sell up to 300 million doses of the new vaccine if the product materialises. The agreement would seem to emulate a similar deal with AstraZeneca in that the Commission secures the supply of vaccines for EU Member States and for a range of lower and middle income countries while financing part of the vaccine’s upfront development costs (see, Van Bael & Bellis Life Sciences News Alert of 31 August 2020). The vaccine now forms the subject of clinical trials and may become available in the second half of 2021 if it completes successfully its regulatory trajectory.
Sanofi and GlaxoSmithKline are developing a recombinant vaccine against Covid-19 that builds on Sanofi’s S-protein Covid-19 antigen, based on recombinant DNA technology, and GSK’s adjuvant technology. The combined approach is hoped to enhance the immune response and facilitate the production of vaccines on a large scale.
On 26 June 2020, the Belgian Official Journal published a Royal Decree of 23 June 2020 (the RD) which introduces an exemption from the marketing authorisation requirement to account for shortages in authorised medicinal products to treat COVID-19 patients.
The RD confers on the Minister of Social Affairs and Public Health, or her representative, the Administrator General of the Federal Agency of Medicines and Health Products (FAMHP), the requisite powers to authorise the supply to COVID-19 patients of unauthorised medicinal products from Belgium’s strategic national stockpile if (i) the FAMHP determines that the medicinal products which are authorised in Belgium for the treatment or the adjunct treatment of COVID-19 are unavailable; and (ii) there is no authorised alternative available either. While the unauthorised medicines are in principle intended for use by hospitals, the RD provides that, upon the request of community pharmacies and subject to the production of a medical prescription, the Minister or her representative can also deliver an unauthorised alternative to community pharmacies. Strict safety reporting obligations apply.
Interestingly, it follows from the Council of State’s opinion on the draft RD that the authorities entertain some doubt as to whether the exemption from the marketing authorisation requirement is compatible with EU law. In particular, the question arises whether the exemption falls within the scope of Article 5(1) and/or Article 5(2) of Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use (Directive 2001/83/EC). Article 5(1) of Directive 2001/83/EC exempts from the need for a marketing authorisation medicinal products which are supplied to satisfy special needs “in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility”. Article 5(2) of Directive 2001/83/EC, in turn, allows EU Member States to “temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm”.
In view of these doubts, the Council of State strongly recommended that clarifications be sought from the European Commission (the Commission) on the occasion of the RD’s notification to the Commission pursuant to Directive 2015/1535. This Directive requires Member States to advise the Commission and other Member States of the technical regulations which they intend to introduce for products and for Information Society services before their adoption. While such regulations are in principle subject to a mandatory standstill period of at least 3 months, Directive 2015/1535 provides for an exception to this standstill requirement in the case of, amongst others, “urgent reasons occasioned by serious and unforeseeable circumstances relating to the protection of public health”.
In view of the urgent need to protect public health, the main provisions of the RD apply retroactively from 13 March 2020. They will expire once the coronavirus COVID-19 pandemic is over in Belgium and at the latest on 31 March 2021.Royal Decree of 23 June 2020
The European Medicines Agency (EMA) announced on 8 June 2020 the results of a meeting held by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events (the Steering Group)(see, attached press release). The Steering Group is a body composed of EMA, the European Commission and national competent authorities in the Member States that was established to tackle the impact of the outbreak of Covid-19 on the supply of medicines in the EU (see, Van Bael & Bellis Life Sciences News Alert of 23 April 2020).
In order to prepare for a possible second spike of coronavirus infections in the fall, the Steering Group decided to task an ad hoc working group within EMA with developing a framework for collecting and sharing demand data in the European Union and the European Economic Area. The working group will also determine the medicines that will fall under its remit and this may extend beyond the intensive care unit medicines for which an immediate need has proven to exist during the first Covid-19 induced emergency. The new group will assemble experts designated by the national competent authorities and was expressly designed to operate during a limited period of time. The working group is expected to prepare a reflection paper summarising best practices derived from national forecasting models and will offer practical recommendations for a harmonised approach to collecting and processing relevant data.
In a letter to Parliament and a press release (see, attachments), the Dutch Minister for Public Health, Wellbeing and Sports, Hugo de Jonge, revealed on 3 June 2020 an initiative of Italy, France, Germany and The Netherlands to work together to secure a Covid-19 vaccine for “the European Union and other countries”.
According to the Minister, the “Inclusive Vaccine Alliance” (IVA) is in talks with several pharmaceutical companies regarding promising ventures and in the process hopes to establish a European manufacturing base for the vaccine. The IVA’s ultimate goal is to create a medicine that is “accessible, available and affordable”.
Other countries will be given the opportunity to join the IVA which is also in contact with the European Commission.
On 1 June 2020, the Italian competition authority (“L’Autorità Garante della Concorrenza e del Mercato”) authorised a scheme that would allow disposable surgical masks to be distributed and sold in pharmacies and health product retail outlets (see, attached press release). It did so at the request of the two principal Italian associations of pharmaceutical wholesalers.
Under the scheme, the wholesalers and associations of pharmacists and health product retailers acquire the masks in a joint procurement procedure. The masks are then allocated among the wholesalers at a uniform price per unit that was agreed upon with the suppliers. The scheme will last until 30 June 2020.
The competition authority approved the scheme because it solves an urgent and wide-ranging health problem and is limited in time. It thus applied for the first time the principles of its guidance of 22 April 2020 regarding cooperation agreements designed to ensure the distribution of scarce essential goods and services, including health products and food.
The competition authority’s approach is in line with the views expressed by the European Commission and competition authorities around Europe to address the problems resulting from the Covid-19 pandemic (see e.g., Van Bael & Bellis Life Sciences News Alert of 9 April 2020 and of 26 May 2020). Not coincidentally, the competition authority indicates that it obtained counsel from the European Commission.
The “Autoridade da Concorrência” (the AC), the Portuguese competition authority, published on 21 May 2020 a warning for professional associations, including the national association of pharmacies (Associação Nacional das Farmácias or ANF), that they should observe the competition rules, even during the Covid-19 crisis (see, attached press release in Portuguese and English versions). The warning also targeted associations in the financial sector.
The message of the AC echoes that conveyed lately by many other competition authorities and indeed the European Competition Network of competition authorities (see, Van Bael & Bellis Life Sciences News Alert of 24 March 2020). These authorities all wish to countenance limited and temporary forms of cooperation by firms that face exceptional circumstances, but will remain tough on egregious forms of collusive or abusive behaviour. In striking a similar balance, the AC would nonetheless seem to be more intent on making sure that Covid-19 is not turned into a pretext for anticompetitive conduct. For example, AC stresses that professional associations should not impinge on the commercial freedom of their members and should not allow members to exchange sensitive commercial information.
The AC says it stands ready to offer informal guidance and specifies that it counseled ANF regarding the maximum margin to be applied to sales of personal protective equipment which was later made subject to regulation.
On 4 May 2020, the European Medicines Agency (EMA) presented the tools which it has started using in order to expedite the development and authorisation of Covid-19 related medicines and vaccines (see, attached press-release and outline of EMA’s rapid formal review procedures related to COVID-19). EMA wants to facilitate the rapid marketing of such products but insists, through its Executive Director Guido Rasi, that this “will only be possible if applications are supported by robust and sound scientific evidence that allows EMA to conclude on a positive benefit-risk balance for these products.”
EMA’s action plan rests on two pillars: (i) accelerated support during research and development; and (ii) faster evaluation in authorisation and post-authorisation procedures.
Research and development - At this stage, EMA will focus on giving rapid scientific advice and authorising speedily pediatric investigation plans.
Authorisation and post-authorisation - Here EMA will rely, as appropriate, on rolling reviews (which allow EMA to assess data as they become available) and accelerated assessments. These procedures will also be open to applications for extensions of indications for medicines that are already on the market and are being repurposed for treatment or prevention of Covid-19.
While not squarely falling within its remit, compassionate use programmes also benefit from EMA’s attention. They are set up and administered by the Member States, but EMA promises to give recommendations for a group of patients and thus contribute to an EU-wide approach.
The EMA had already occasion to put parts of its action plan in practice when starting a rolling review of remdesivir and, earlier, offering recommendations for compassionate use programmes involving remdesivir.
On 29 April 2020, the European Commission (the Commission) published its first comfort letter assessing a cooperation project under its “Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak” (see, our Life Sciences News Alert of 9 April 2020).
This comfort letter dated 8 April 2020 is addressed to “Medicines for Europe” (MfE), a trade association formerly known as the European Generic and Biosimilar Medicines Association. Members of MfE plan to offer a collective response to the “acute risk of medicines shortages in the EU” caused by “the sudden, pan-European surge in demand for certain COVID-19 hospital medicines”. This risk of shortages notably concerns deep sedatives, neuromuscular blockers, strong analgesics, vasopressors, antibiotics and adjuvants.
The proposed cooperation is fairly extensive: participating pharmaceutical companies will cooperate to model demand, to identify production capacity and stocks, and to adapt or reallocate such production and stocks based on projected or actual demand. This will entail a coordination of available production capacity, which may involve cross-supplying active pharmaceutical ingredients and identifying jointly where to best switch production from certain medicines to others and/or increase capacity. Participants would “potentially also address the distribution of COVID-19 medicines”.
The Commission considered that “in the present exceptional circumstances [these] cooperation practices […] do not raise concerns under Article 101 of the Treaty on the Functioning of the European Union”, based on two sets of circumstances. First, the Commission referred to the request made by Commissioner for Health and Food Safety Stella Kyriakides to pharmaceutical companies to work together to respond to the increased demand. The Commission will itself provide a forum for these exchanges and “will have a steering role in the process”. Second, the Commission noted that the cooperation “is necessary to achieve the increases in production and to improve the supply of those urgently needed COVID-19 medicines across the EU in the most efficient way”.
The comfort letter was issued subject to the following conditions:
(i) The cooperation will be open to any interested pharmaceutical company;
(ii) Minutes of all meetings will be taken and kept and copies of all agreements concluded will be shared with the Commission;
(iii) The information exchange will be limited to the minimum indispensable to achieve the objectives of the cooperation and the information will be gathered by MfE (or an external third party appointed by MfE) and provided to the members in aggregated form only (the Commission will provide a “controlled forum for exchanging sensitive information” and involve the European Medicines Agency and national health systems as relevant);
(iv) The cooperation will only apply as long as there are risks of shortages (“including in a possible second wave of the COVID-19 pandemic”) and the Commission may decide when these risks subside;
(v) Participating companies will not confer on prices and will not even increase same “beyond what is justified by possible increases in costs”; and
(vi) Participating companies will not seek “to exploit the crisis as a ‘cover’ for non-essential collusion or other anticompetitive behaviour”.
On 28 April 2020 the European Commission published an update of the guidance which it prepared with the European Medicines Agency and the national Heads of Medicines Agencies on how to manage clinical trials during the Covid-19 pandemic (see, attachment – the Updated Guidance).
The Updated Guidance expands on advice given in March 2020 (see, Van Bael & Bellis Life Sciences News Alert of 23 March 2020) by clarifying the following subjects:
• Distribution of investigational medicinal products to patients in clinical trials: the Updated Guidance seeks to preserve the safety and wellbeing of clinical trial participants and the integrity of the clinical trials. The new recommendation grapples with the reality of social distancing measures and possible limitations on trial site resources.
• Remote source data verification (SDV): Since the outbreak of the pandemic verifying raw data at the trial site has at times become very difficult because of safety measures such as social distancing. Remote SDV could facilitate the marketing authorisation process of potentially life-saving medicines.
• Communication to authorities: Urgent actions to protect trial participants against any immediate hazard or other changes with an effect on patient safety or data robustness may become necessary. The Updated Guidance clarifies the classification and notification of such actions.
These measures will only apply during the time of the Covid-19 pandemic and will be revoked once the pandemic will have been overcome.
The Official Journal of the European Union publishes today Regulation (EU) 2020/561 of 23 April 2020 “amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions” (see, attachment – the Regulation). The Regulation formally delays the application of the Medical Devices Regulation (the MDR) by one year until 26 May 2021. Furthermore, for medical devices needed in the response to the COVID-19 pandemic, the Regulation allows for Union-wide derogations from the prohibition to place medical devices on the market for which the relevant conformity assessment procedures have not been carried out.
The Regulation was adopted by the European Parliament and the Council of Ministers on respectively 17 and 22 April 2020, less than three weeks after the European Commission had proposed the delay.
The recitals to the Regulation justify the delay solely by referring to the extraordinary circumstances associated with the COVID-19 outbreak, noting that “[g]iven 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”. This justification is remarkable as there had already been a strong call for a delay before the COVID-19 outbreak in view of the small number of notified bodies recognised under the MDR and the delay in making the European database on medical devices operational (Eudamed).
For its part, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) is still set to take effect on 26 May 2022. However, the European trade association for the medical devices sector, MedTech Europe, is calling for a similar delay for the IVDR, noting that “even before the COVID-19 pandemic, very little progress had been achieved yet, to get the new IVDR regulatory system ready” and that “since the present COVID-19 outbreak, the IVDR implementation progress has come to a total halt” (see, attachment).
On 21 April 2020, the European Medicines Agency (EMA) launched its enhanced monitoring system to address supply issues with medicines used for the treatment of patients affected by Covid-19 (see, attached press release). Pursuant to this system, first announced earlier this month, each pharmaceutical company will have an industry single point of contact (i-SPOC) to report to EMA and to the national competent authorities all current and expected shortages of Covid-19 related medicines.
The EMA system applies to both centrally and nationally authorised medicines and builds on the EU SPOC network, a network of single points of contact in national competent authorities which EMA, the European Commission and these national competent authorities have already been using since April 2019 to share information on medicine shortages.
The information generated through the i-SPOC network will inform the EU Executive Steering Group on Shortages of Medicines Caused by Major Events which will decide on possible actions coordinated at EU level to address shortages.
In addition to their commitments under the EMA system, pharmaceutical firms will continue to have reporting obligations to national competent authorities under Member State rules.
On 21 April 2020, Marin Mrčela, the president of the Group of States against Corruption (GRECO), an anti-corruption monitoring body which forms part of the Council of Europe, published guidelines for its 50 member countries aimed at preventing corruption and other forms of illicit behaviour, both criminal and otherwise, in the context of the Covid-19 pandemic (see, attached press release and guidelines). According to GRECO, the current circumstances are conducive to corruption because of a combination of health emergencies, concentration of power, derogations from fundamental rights and freedoms, and the infusion of considerable government funds into the economy.
Accordingly, the guidelines focus on irregularities in the procurement system, bribery in medical services, corruption in new medicinal product research and development, private sector corruption and fraud specific to Covid-19, including counterfeiting, falsifying documents and commercialising unauthorised medicines and medical devices. The guidelines are not confined to highlighting these more dramatic types of corruption, but also dwell on less spectacular possible sources of illicit behavior such as conflicts of interest and lobbying activities that lack transparency. The guidelines go on to stress the benefits of oversight in its various forms and of whistleblowing activities.Press Release Guidelines
The European Commission, the European Medicines Agency (EMA) and the national Heads of Medicines Agencies (HMA) published on 20 April 2020 an updated version of their Q&A “on regulatory expectations for medicinal products for human use during the COVID-19 pandemic” (see, attachment – the Updated Regulatory Q&A). The Regulatory Q&A was first published on 10 April 2020 and provides guidance to marketing authorisation holders of medicinal products for human use (MAH) on regulatory expectations during the COVID-19 pandemic and on whether regulatory flexibility is possible to help reduce the risk of shortages (see, Van Bael & Bellis Life Sciences News Alert of 14 April 2020).
The Updated Regulatory Q&A includes four new questions and answers concerning (i) good manufacturing practice (GMP) and authorisations to import/export; (ii) good distribution practice (GDP) certificates and wholesale authorisations; (iii) qualified persons (QP); and (iv) adverse event reporting.
First, as regards GMP and import/export authorisations, the Updated Regulatory Q&A provides for an automatic extension of the validity of GMP certificates and time-limited authorisations/registrations to manufacture/import until the end of 2021. This is to avoid disruptions in the availability of medicines due to the current travelling and other restrictions that prevent on-site GMP inspections. There is no need for further action from the holder of the certificate or authorisation/registration. For sites located outside the European Economic Area (EEA), the extension will apply “unless the issuing/supervisory authority takes any action that affects the validity of the certificate”. For new sites and facilities within and outside the EEA that have not been inspected or where an inspection is required, the Updated Regulatory Q&A offers the possibility of distant assessments. However, on-site inspections should be conducted when circumstances permit and will resume as soon as COVID-19 restrictions are lifted.
Second, the validity of GDP certificates and time-limited wholesale authorisations is similarly extended through the end of 2021 without the need for further action from the holder of the certificate or authorisation.
Third, the Updated Regulatory Q&A explains which adaptations to the work of the QP are possible considering the travelling and other restrictions arising from the COVID-19 pandemic. While stressing that the obligations/responsibilities of the QP remain unchanged, the Updated Regulatory Q&A notes that remote batch certification should currently be acceptable in all EEA Member States. Furthermore, where on-site audits of active substance manufacturers are not possible, the QP can rely on paper-based audits and also take into consideration the results of inspections from EEA authorities. Finally, the Updated Regulatory Q&A allows QPs to rely on a wide range of documents to support the batch release of imported investigational products from third countries.
Fourth and lastly, as regards adverse event reporting, the Updated Regulatory Q&A instructs MAH who are for justified reasons relating to the pandemic unable to continue standard reporting operations to prioritise temporarily (i.e., until the pandemic is resolved) the reporting of (serious or non-serious) Individual Case Safety Reports (ICSR) associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic over the reporting of other (serious or non-serious) ICSR. In this case, the MAH should put a note in the pharmacovigilance system master file recording this practice. Importantly, the Updated Regulatory Q&A stresses that “it is essential that MAHs report all serious ICSRs within the 15 days set out in Directive 2001/83/EC”.Updated Regulatory Q&A
The European Commission (the “Commission”) published on 15 April 2020 its “Guidelines on COVID-19 in vitro diagnostic tests and their performance” (see, attached guidelines and factsheet). The Guidelines present the regulatory context for COVID-19 test devices; give an overview of the different test types and their purposes; explain the importance of tests being designed to reach an intended performance; and underline the significance of validating that performance in real life. Additionally and importantly, the Guidelines list the action points already taken care of by the Commission and the steps which still have to be taken by the Commission, Member States and other stakeholders.
On that last point, the Commission envisages the following measures:
• The Commission will facilitate the discussion of national testing strategies to promote a common EU approach but points out that it will do so “as far as this is appropriate”. According to the Commission, national strategies should take account of the intended purpose of each type of test and the implications of the use of a specific device in a given context, including the targeted population groups and the phase of the disease in which the test will be used. The Commission indicates that attention should be paid to performance parameters such as the diagnostic sensitivity, the diagnostic specificity and the limit of detection of the device for the given context and purpose.
• The Commission will assist Member States with a centralised overview of available information on test performance and act as a single point of contact for managing this information.
• The Commission, Member States, and stakeholders will discuss best practices and tools for assessing the performance of different types of COVID-19 tests. They will also harmonise approaches across the EU in tackling issues such as reference materials and methods for standardised comparison. The Commission will consider funding mechanisms to support these activities.
• The Commission will facilitate the placing on the market of safe and reliable test devices.
• The Commission will encourage maximum collaboration of regulators to remove counterfeit devices from the market.
• The Commission will establish a network of COVID-19 reference laboratories across the EU as well as a platform to support them.
• To make sure that sufficient numbers of performing tests and the requisite reagents are available, the Commission will encourage industry and the Member States to make use of EU instruments to coordinate supply and demand. The Commission cites the examples of the clearing house, rescEU and the joint procurement instrument. The production of sufficient volumes of tests will require enhanced cooperation between companies, which can be done under the safe haven put in place by the Commission’s Temporary Framework for assessing business cooperation under the competition rules (see, Van Bael & Bellis Life Sciences News Alert, 9 April 2020).
• Not for the first time, the Commission stresses the importance of solidarity among Member States in making arrangements for the fair distribution of available stocks and laboratory equipment in order to ensure that supplies meet genuine needs.Guidelines Factsheet
The European Commission, the European Medicines Agency (EMA) and the national Heads of Medicines Agencies (HMA) published on 10 April 2020 a Q&A document “on regulatory expectations for medicinal products for human use during the COVID-19 pandemic” (see, attachment – the Regulatory Q&A). In recognising the need to minimise risks of shortages while maintaining high standards of quality, safety and efficacy of medicines made available to patients, the Regulatory Q&A provides guidance to marketing authorisation holders of medicinal products for human use (MAH) on regulatory expectations during the COVID-19 pandemic and on whether regulatory flexibility is possible to help to reduce the risk of shortages.
The Regulatory Q&A addresses four areas in which MAH may face constraints in the context of COVID-19.
First, with respect to marketing authorisations (MA), the Regulatory Q&A explains how MA procedures for medicines for use in COVID-19 patients can be expedited and how unauthorised medicinal products could be made available to patients. Further, it provides guidance to MAH facing difficulties to meet the deadline for filing renewal applications and to MAH facing the application of the “sunset clause”.
Second, with respect to manufacturing and supply, the Regulatory Q&A describes the “exceptional change management process” (ECMP) which has been introduced to allow MAH of crucial medicines for use in COVID-19 patients to (i) source starting materials, reagents, intermediates or active substances from suppliers not specifically mentioned in the MA; and (ii) use manufacturing sites or sites responsible for quality control that are not specifically mentioned in the MA. This regulatory leeway comes by way of exception, if this is necessary to prevent/mitigate shortages of supplies in the EU.
Third, the Regulatory Q&A explains that, without prejudice to the flexibilities afforded by the ECMP, the customary quality requirements continue to apply, including for medicinal products that are administered to COVID-19 patients. Any changes to the quality requirements foreseen in the MA should be submitted in the form of variations and will be assessed promptly if the variation request is identified as COVID-19 related.
Fourth and lastly, as regards labelling and packaging requirements, the Regulatory Q&A stresses that the regulatory flexibilities foreseen in Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use “should be fully utilised” to facilitate the movement of medicinal products within the EU so that they can be made available in the EU Member States where most needed.
The European Commission published on 8 April 2020 guidelines “on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak” (see, attachment – the Shortage Guidelines). In recognising the possible need for Member States to take exceptional measures to protect public health, the Shortage Guidelines offer the Member States pointers on how to bridge the gap between supply and demand and reduce the risk of shortages of essential COVID-19 medicines.
The Shortage Guidelines urge the Member States to show solidarity by (i) lifting export bans and restrictions; (ii) avoiding national stockpiling; and (iii) shunning misinformation at the root of improper use and stockpiling.
The Shortage Guidelines also make more practical recommendations on the supply side by listing action points for every part of the supply chain. First, at the production level, the Shortage Guidelines stress the need for an increase in production, the maintenance of full manufacturing capacity and the application of regulatory flexibility. Second, with respect to distribution, the Shortage Guidelines advocate a further range of measures such as monitoring stock levels, supporting wholesalers, enforcing the cross-border “green lanes”, facilitating various forms of transport, including air freight, and preserving the fair distribution of medicines. Third, the Shortage Guidelines also stress the importance of an optimal use of medicines in hospitals listing measures such as ensuring a fair distribution or reallocation of medicines between hospitals depending on needs and more far-reaching steps such as extending the expiry dates of medicines and resorting to off-label use. Fourth and lastly, the Shortage Guidelines show how to optimise sales in community pharmacies and avoid hoarding.
The European Commission just published a Temporary Framework to assess under the competition rules possible forms of business cooperation in response to the emergency situation caused by the COVID-19 outbreak. The forms of cooperation which the Commission seeks to facilitate mainly concern the life sciences sector. The attached note which our office prepared explains why and how.
Autoriteit Consument en Markt, the Dutch competition authority (“ACM”), published on 3 April 2020 a press release expressing satisfaction with commitments made by Roche Diagnostics (“Roche”) regarding the supply of testing materials for the SARS-CoV-2 test (see, attachments). Roche, which ACM says has a “key position” for testing equipment and materials in The Netherlands, had been accused of withholding such materials, including lysis buffer solution, a reagent used to break open cells. On 26 March 2020, the Dutch second Parliamentary Chamber even voted a resolution which observed a shortage of that solution, attributed blame for the alleged shortage to Roche, and called on the government to compel Roche to share the recipe, if necessary by relying on a compulsory patent licence.
Roche rejected the allegations and pointed out that it had not even claimed patent protection for the recipe. According to Roche, which pointed out that it developed the first SARS-CoV-2 test in record time, the issue had arisen because Roche could not guarantee the safety and reliability of test results if the reagents were produced in facilities not under its control.
For its part, ACM made it clear that Roche had exhibited a “constructive attitude” by sharing the recipe for lysis buffer solution and helping in expanding production. This is why ACM did not consider further action necessary. In passing, ACM pointed out that it had worked closely with the European Commission as many Member States are grappling with similar problems.
On 25 March 2020, the European Commission (the Commission) published guidance to the Member States of the EU concerning the limitation of foreign direct investment (“FDI”) and free movement of capital from third countries in order to protect Europe’s strategic assets, especially its healthcare capacities (see, attachment).
The Commission considers that, in the context of the COVID-19 pandemic, there could be “an increased risk of attempts from non-EU investors to acquire healthcare capacities (for example for the production of medical or protective equipment) or related industries such as research establishments (for instance developing vaccines) via foreign direct investment”. According to the Commission, if left unchecked, FDI could hamper the EU’s capacity to cover the health needs of its citizens.
Since the responsibility for screening FDI lies with EU Member States, the Commission calls upon them to (i) make full use of their screening mechanisms “to take fully into account the risks to critical health infrastructures, supply of critical inputs, and other critical sectors”; and (ii) to set up a screening mechanism if they do not yet have one “and in the meantime to use all other available options”. EU Member States should thus avert FDI liable to “create a risk to security or public order in the EU, including a risk to critical health infrastructures and supply of critical inputs”.
The Commission also refers to Regulation (EU) 2019/452 establishing a framework for the screening of FDI into the Union (FDI Screening Regulation), which will apply as of 11 October 2020. The FDI Screening Regulation lists critical health infrastructure among the factors which may be taken into consideration in determining whether FDI is likely to affect security or public order. The FDI Screening Regulation also sets up a cooperation mechanism between the Commission and Member States in order to tackle FDI that creates risks in several Member States. Finally, the Commission provides guidance on the possible justifications for restricting capital movements.Guidance to Member States concerning Foreign Direct Investment
The Belgian Federal Agency for Medicines and Health Products (FAGG/AFMPS; FAMHP) published yesterday its national addendum (the Addendum) to the EU Guidance on the Management of clinical Trials during the COVID-19 (Coronavirus) Pandemic that was released on 20 March 2020 (see, Van Bael & Bellis Life Sciences News Alert of 23 March 2020; the EU Guidance).
The Addendum was prepared jointly by the FAMHP, the Clinical Trial College, the Belgian Association of Research Ethics Committees (BAREC) and certain research centres. It complements the EU Guidance with practical guidelines tailored to the Belgian context in relation to the following topics:
1. Procedural matters: The Addendum invites sponsors to contact the FAMHP prior to submitting a COVID-19 related trial. For national COVID-19 related trials, the Addendum “strongly recommends” the use of the ongoing pilot project for the new Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014), which is faster and simpler than the regular application procedure.
2. Restrictions of visits to healthcare facilities: If a Belgian patient is enrolled in a trial in another EU Member State which was not launched in Belgium, and the foreign site closes due to the COVID-19 situation, the Addendum promotes the use of named patient imports or compassionate use programmes to ensure that the patient benefits from continued access to the medication.
3. Direct-to-patient supplies of investigational medicinal product (IMP): Direct shipment from sponsor to patient is not allowed in Belgium for privacy reasons (the sponsor must not be able to identify the patient). In contrast, direct shipments from the trial site to the patients are allowed, subject to the following conditions:
i. the shipment takes place under the principal investigator’s responsibility;
ii. the shipment takes place without sponsor involvement;
iii. the IMP is shipped under correct shipping conditions;
iv. the shipment is accompanied by correct and traceable documentation (the Addendum emphasises that “documentation is paramount”); and
v. the patient is trained for storage and administration at home, or the product is administered by a caregiver, nurse or physician who is trained in terms of the protocol.
4. Notification of temporary halts and urgent safety measures: The Addendum clarifies how and when temporary halts of a trial (e.g., a recruitment halt or halt of the trial at a specific site) should be notified to the FAMHP and the ethics committee and how the trial can be resumed. Urgent safety measures can be taken in the context of the coronavirus situation without prior notification to the FAMHP and the ethics committee (subsequent reporting suffices).
5. Remote source data verification: Remote source data verification (i.e., remote sponsor access to the medical dossier and medical records of trial subjects) is neither allowed (breach of the rights of the trial subjects) nor recommended in Belgium (excessive burden on site staff to redact medical charts at this time and no sufficient verification by sponsor monitors possible).
6. Electronic communication and electronic signatures: The FAMHP is willing to show flexibility and will not require qualified electronic signatures in the present circumstances.
Likewise to the EU Guidance, the Addendum is expected to be updated regularly.
Incidentally, the European Medicines Agency yesterday released for consultation a draft guideline on points that clinical trial sponsors should consider on the implications of the coronavirus disease on the methodological aspects of ongoing clinical trials. The deadline for comments is 25 April 2020.
The Belgian Official Journal of 25 March 2020 contains the text of the Royal Decree of 24 March 2020 providing for special measures to combat medicine shortages resulting from the pandemic created by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Koninklijk Besluit houdende bijzondere maatregelen ter bestrijding van tekorten van geneesmiddelen in het kader van de SARS-CoV-2 pandemie/Arrêté royal relatif à des mesures spéciales de lutte contre la pénurie de médicaments dans le contexte de la pandémie de SARS-CoV-2) (the Royal Decree – see, attachment).
The Royal Decree confers on the Minister responsible for public health, or her representative, the Administrator General of the Federal Agency of Medicines and Health Products, the requisite powers to avert shortages of medicines necessary to combat the coronavirus.
These powers include a range of measures, including imposing an export prohibition of medicines or ingredients; limiting the distribution or retail of medicines; rearranging the distribution of medicines or ingredients; and requisitioning stocks of medicines or ingredients. These measures cannot last longer than renewable periods of one month, subject to a total of 12 months. The Royal Decree itself will expire on 25 March 2021.
On 23 March 2020, the European Competition Network (ECN), which includes the European Commission and the national competition authorities of the EU, issued a statement “on application of competition law during the Corona crisis” – see attachment.
The ECN explains that it “understands that this extraordinary situation may trigger the need for companies to cooperate in order to ensure the supply and fair distribution of scarce products to all consumers”. Given this state of affairs, the ECN “will not actively intervene against necessary and temporary measures put in place in order to avoid a shortage of supply”. According to the ECN, such measures would not be anticompetitive: either they would not amount to a restriction of competition or they would be exempted as the efficiencies generated would “most likely outweigh any such restriction”. The ECN invites any company in doubt regarding the legality of a possible cooperation initiative to contact the European Commission, the EFTA Surveillance Authority or a national competition authority for informal guidance.
At the same time, the ECN also stresses that “it is of utmost importance to ensure that products considered essential to protect the health of consumers in the current situation (e.g. face masks and sanitising gel) remain available at competitive prices”. Therefore, the ECN will “not hesitate to take action against companies taking advantage of the current situation by cartelising or abusing their dominant position”. The ECN also reminds manufacturers that they can impose maximum resale prices for their products, which “could prove useful to limit unjustified price increases at the distribution level”.
This statement echoes the position which was adopted recently by the Competition and Markets Authority in the UK and by the Bundeskartellamt in Germany.
The European Commission, the European Medicines Agency (EMA) and the national Heads of Medicines Agencies (HMA) released on 20 March 2020 guidance for clinical trial sponsors on how to manage their clinical trials during the COVID-19 pandemic (the Guidance; available here). The Guidance aims to serve as an EU-level harmonised set of recommendations on changes and protocol deviations which may needed due to, e.g., trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infections and health care professionals being reallocated.
Furthermore, the Guidance provides specific advice on the initiation of new clinical trials for potential COVID-19 treatments or vaccines.
Guidance on Conduct of Clinical Trials During COVID-19 Pandemic
The key objective of the Guidance is to ensure the safety of trial subjects across the EU while preserving the quality of the data generated by the trials. According to the Guidance, sponsors should consider specific measures such as:
• postponing or cancelling site visits or converting physical patient visits into phone or video visits;
• temporarily halting the trial at some or or all trial sites;
• suspending or slowing down recruitment of new trial participants;
• extending the duration of the trial;
• postponing trials or activating sites that have not yet been initiated;
• closing sites; and/or
• if unavoidable, transferring trial subjects to, for instance, investigational sites away from risk zones or closer to their home, or to sites already participating in the trial.
The Guidance emphasises that, when changes in ongoing trials are considered, the overall well-being and best interests of the trial subjects should be duly considered (e.g., in trials for patients with life-threatening or severely debilitating conditions, when participants require to stay on trial treatment) as well as the legitimate interest of trial sites in avoiding further burdens in terms of time and staffing during the COVID-19 pandemic.
Additionally, the Guidance discusses matters such as:
• the risk assessment to be carried out by sponsors, which should consider the added challenges due to COVID-19 and pay particular attention to the interests of patients enrolled in ongoing trials who may be at risk for COVID-19 or who are in trials involving therapies which may increase such risk;
• communication with authorities (authorities will give priority to new clinical trial applications for the treatment or prevention of COVID-19 infection and/or substantial amendment applications to existing clinical trials necessary as a result of COVID-19);
• alternative ways to seek informed consent;
• changes in the distribution of the investigational medicinal product (e.g., to remove avoidable visits to sites and to provide the patients with needed treatments);
• alternative ways for sponsors to monitor clinical trial conduct at sites; and
• protocol deviations.
Importantly, the Guidance emphasises that “there might be specific national legislation and guidance in place, which they should consult and which can be used to complement this guidance, or, with respect to particular matters may take priority over these recommendations”. For example, the Belgian Federal Agency for Medicines and Health Products (FAGG/AFMPS) has already announced that, on 25 March 2020, it will publish national guidelines covering specific issues, including that of direct-to-patient supplies of investigational medicinal product (see, here (Dutch version) and here (French version)).
Due to the rapidly evolving situation, further updates to the Guidance “are possible and likely”.
Similar guidance was issued by the US Food and Drug Administration (FDA) on 18 March 2020.
Specific Advice on Initiation of Clinical Trials for Treatments of COVID-19
In line with a call issued by EMA’s Committee for Medicinal Products for Human Use (CHMP) for robust trial methodology in clinical trials for potential COVID-19 treatments or vaccines, the Guidance notes that “[t]he Member States support the submission of large, multinational trial protocols for the investigation of new treatments for COVID19”.
In its call, CHMP had noted being “concerned about the amount of planned small studies or compassionate use programmes across Europe that are unlikely to be able to generate the required level of evidence to allow clear-cut recommendations”. According to CHMP, “[s]uch studies would not be in the best interests of patients”. Therefore, it favours instead “[m]ulti-arm clinical trials investigating different agents simultaneously” as such trials “have the potential to deliver results as rapidly as possible across a range of therapeutic options according to the same evaluation criteria”. CHMP added that “[i]t would be important that all EU countries are considered for inclusion in such trials”.
The Guidance encourages sponsors to consider the submission of any applications for COVID-19 related clinical trials for an accelerated Voluntary Harmonisation Procedure (VHP) assessment when possible.
Additionally, EMA provides a full fee waiver and a fast-track procedure for scientific advice (see also, here).
Trade & Customs
The EU Commission has published a Communication entitled “Guidance on Customs issues related to the COVID-19 emergency” providing practical information for day-to-day customs operations in view of the COVID-19 crisis.
The Communication addresses various issues, namely: e-commerce - customs representation, customs decisions, customs debts and guarantees, entry of goods, customs procedures, transit, special procedures, and exit of goods.
The attached memorandum provides you some of the points raised in the Communication.Memorandum
On 13 March 2020, the European Commission published a Notice on the consequences of the COVID-19 outbreak on antidumping and anti-subsidy investigations (the Notice).
Pursuant to the Notice, the COVD-19 outbreak will affect the anti-dumping and anti-subsidy investigations carried out by the European Commission as follows:
1. Suspension of verification visits
The Commission decided to suspend all verification visits to the affected areas until further notice. Instead, the Commission will carefully examine the information provided by interested parties in the framework of the investigations and cross-check it with information available from other sources. Moreover, if the Commission considers the information submitted inaccurate or incomplete, it will base its findings on verified or other proven facts on the record of the investigation.
In view of this, it becomes essential for all exporting producers cooperating with the European Commission to provide a complete, accurate and substantiated questionnaire response supplemented by all necessary annexes and worksheets in order to enable the Commission to verify and reconcile the data without visiting the company’s premises.
2. Extended deadlines
Due to the extraordinary circumstances, the Commission may grant a 7-day extension to companies located in areas affected by the COVID-19 outbreak.
Furthermore, the Commission will consider granting a longer extension if the requesting company is particularly affected by additional substantial safety measures (such as quarantine periods and/or mandatory factory closures). In order to qualify for an additional extension, the requesting company has to provide a sufficient explanation on how the additional time would help to prepare a more comprehensive questionnaire response. It is also necessary to describe how the additional substantial safety measures affect the requesting company’s capacity to provide the required information.
It must be noted that the Notice does not address the impact of the COVID-19 outbreak on the on-going second review of the steel safeguard measures. Therefore, it remains to be seen whether the timeframe of the review or any of its substantive aspects will be affected by the pandemic.
Please click here to access the Notice.
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