Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes

On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020.

One of the main objectives of the bill is to make everyday life easier for patients and healthcare professionals by increasing use of innovative digital applications, while protecting sensitive health data. It is assumed that increased digitalisation in the healthcare sector will open up opportunities at all levels of healthcare, both for patients and healthcare providers. As such, it is expected that digitalisation will help to take care of the growing number of chronically ill patients, to relieve the burden on specialists, to make better use of resources and to prepare the healthcare system for the challenges of the future.

A series of documents that so far has only been provided and used in hardcopy, such as certain prescriptions or patient files, will now be made available in digital form. In addition, a special app shall be made available to enable patients to redeem digital prescriptions in pharmacies. Alternatively, patients may present a 2D barcode on paper. In this case, the prescription will also be transmitted to the pharmacy in digital format. Further, the law aims to enable patient referrals from one doctor to medical specialists to be made in digital form (currently this is done in writing and requires the referral to be collected from the doctor’s office).

From 2021, statutory health insurance providers will be obliged to offer their insured persons electronic patient files (ePA). To ensure that this is effectively used, patients may request that their doctor include their medical records in their personal ePA. In addition, from 2022, the ePA will also be able to display other information that is currently only documented in hardcopy, for example, maternity logs, paediatric health records and vaccination cards. To incentivise doctors, they will be paid to use ePAs. Patients will ultimately have control over their ePAs and be able to decide which data is stored there and who will have access. For example, patients may specify that a doctor may have access to the ePA, but that certain findings are not displayed. The protection of the processed patient data is ensured by a gapless regulation of the chain of responsibilities.

From 2023 onwards, patients will have the option of voluntarily making the data in their ePAs available to researchers as part of a “data donation”. The donation could become an important element to increasing the availability of real-world evidence on new treatments and medicines. Informed consent will be required from each of the patients, and it will be possible for that consent to be given digitally. Patients will be free to choose the scope of their data donation and can limit access to certain information. The data that is released will be restricted to certain research purposes, like research on improving the quality of healthcare.

This new law will have a significant impact on the digitalisation of the entire German healthcare system. It will also create a better infrastructure for research with patient data and for collecting real-world-evidence for scientific and regulatory purposes.

Healthcare companies, providers and payors as well as technology and research companies should closely follow the next steps of this legislative development in Germany.

Advocate General delivers Opinion on Novel Food Status of Insects

By Bart Van Vooren and Loïc Waty on July 16, 2020 Posted in European Union, Food & Beverage, Food & Drug Regulatory

On 9 July 2020, Advocate General Bobek delivered his opinion on the status of edible insects (e.g., mealworms, locusts, and crickets) under the EU novel foods rules. While insects fall under the scope of the new EU Novel Food Regulation 2015/2283, the opinion recommends the Court of Justice to deny novel food status to such ingredients under the old legal regime of now repealed Regulation 258/97. Continue Reading

Manufacturers and Marketers Beware: The EU Adopts New Restrictions on Products Containing PFOAs

By Cándido García Molyneux and Lukasz Gorywoda on July 16, 2020 Posted in Food & Drug Regulatory, Medical Devices, Medicinal Products, Pharmaceutical companies

Since July 4, 2020 the manufacture, marketing and use of perfluorooctanoic acid (“PFOA”), its salts and PFOA-related compounds (collectively, “PFOAs”), and products containing them, is significantly restricted in the European Economic Area (“EU/EEA”). The restrictions were introduced by a Commission Delegated Regulation amending Annex I to the EU POPs Regulation, and are intended to implement a decision of the ninth meeting of the Conference of the Parties to the Stockholm Convention that was held from April 29 to May 10, 2019.

The new PFOA restrictions will have significant impact on a wide variety of products marketed, and businesses operating, in the EU/EEA, including semiconductors, textiles, firefighting products, pharmaceuticals, medical devices, and materials used in the life sciences industry. In effect, the new restrictions implementing the Stockholm Convention are significantly broader than the restrictions on PFOAs that were introduced under the EU REACH Regulation in 2017, and which the Commission now intends to repeal. Continue Reading

The European Commission Announces a Sustainable Food Strategy for Europe

By Cándido García Molyneux and Loïc Waty on May 29, 2020 Posted in Food & Beverage, Food & Drug Regulatory

The COVID-19 pandemic has focused attention on the need for resilient supply chains, including perhaps most importantly, the critical need for sustainable supplies of healthy food. In line with this, the European Commission (the “Commission) has published a Communication on a Farm to Fork Strategy (the “Strategy”) where it announces a series of legislative and policy initiatives intended to place sustainability at the center of EU food law and policy by ensuring fair, healthy and environmentally-friendly food systems. The Strategy is one of the main pillars of the European Green Deal that, in December 2019, the European Commission announced as its policy flagship for the next five years.

Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic

By Marie Doyle-Rossi and Anna Herrmann on April 30, 2020 Posted in COVID19, Food & Drug Regulatory

On 28 April 2020, the European Commission published further Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (the “Guidance”), supported by the European Medicines Agency (EMA) and the national Heads of Medicines Agency (HMA). The Guidance is an update to the previous version published in late March (see InsideEULifeSciences blog post here).

As outlined in the Commission’s press release, the Guidance’s objective is to mitigate clinical trial disruption in Europe during the COVID-19 pandemic. The Guidance introduces pragmatic and harmonizing measures that facilitate changes to trials

“…to ensure the necessary flexibility and procedural simplifications needed to maintain the integrity of the trials, to ensure the rights, safety and wellbeing of trial participants and the safety of clinical trial staff…”

As clinical trials in the EU are authorized at the national level, the Guidance encourages Member States to implement its recommendations “to the maximum possible extent” and to add to the Guidance where clarity on national legislation and derogations is needed. The Guidance does not supersede any current national legislation and derogations and the measures introduced will be revoked once the COVID-19 pandemic has passed.

The Guidance’s recommended measures include, amongst others, the following:

Initiating new trials: Sponsors must assess the “feasibility and immediate necessity” of starting a new clinical trial. Sponsors should submit any large, multinational trial protocols for the investigation of new treatments for COVID-19 via the accelerated ‘Voluntary Harmonisation Procedure’. Further, developers of medicines or vaccines against COVID-19 are invited to e-mail the EMA via 2019-ncov@ema.europa.eu.
Changes to ongoing trials: The Guidance recommends possible changes to restrict site visits to those “strictly necessary”, e.g., temporarily halting trials or closing trial sites, slowing down the recruitment of new trial participants, converting physical site visits into phone or video visits, or even, in exceptional cases, running routine diagnostic tests at a relevant local, authorized clinical facility rather than the trial site itself.
Changes to safety reporting: Investigators may collect adverse events from the trial participant through alternative means, e.g., by phone calls or telemedicine visits, as appropriate.
Changes to informed consent: Where written consent by the trial participant is not possible, consent mat be given orally by the trial participant in the presence of an impartial witness. The witness must sign and date the informed consent form. Further, where re-consent for changes to trial conduct is necessary, a site visit should be replaced with oral consent, where possible.
Changes in the distribution of the investigational medicinal products (“IMP”): The Guidance recommends measures to limit site visits and pre-empt possible supply chain failures, e.g., by storing larger amounts of IMP at the site, making larger amounts of IMP available to trial participants, delivering IMP to trial participants’ homes directly, and even, in exceptional cases, permitting distributors to deliver to trial participants directly in order to alleviate the sponsors’ increased burden of IMP shipments.
Changes in the distribution of in vitro diagnostic and medical devices: The Guidance recommends measures to pre-empt possible supply chain failures, e.g., by maintaining appropriate stock of devices. Any such stockpiling must not pose a risk to the treatment of patients outside the trial.
Changes to monitoring: There should be a risk-based approach to any changes to monitoring. The Guidance recommends measures to replace or reduce on-site monitoring where it cannot be cancelled or postponed by conducting monitoring by, e.g., phone calls, video visits, and centralized monitoring of data acquired by electronic data capture systems, or, in exceptional cases and bearing in mind trial participants’ data protection rights, remote Source Data Verification (“SDV”) of medical records. Annex I of the Guidance outlines certain controls to protect trial participants’ rights during remote SDV.

In relation to communication with authorities, the Guidance emphasizes that the relevant competent authorities and ethics committees must be informed of:

substantial amendments;
urgent safety actions; and
other COVID-19 related changes not related to participants safety and that do not seriously affect the benefit-risk balance for the participants and the scientific value of the trial.

Sponsors should mark all such communications with COVID-19 in the subject field. The Guidance also provides a non-exhaustive list for the classification of mitigation measures such as: (i) substantial amendments; (ii) urgent safety actions; or (iii) other measures.

Going forward, Health and Food Safety Commissioner, Stella Kyriakides, emphasized that “…it is absolutely crucial that we show flexibility in our rules to maintain research on critical treatments…” Due to the rapidly evolving situation, the Commission has advised sponsors and investigators that further updates to the Guidance are possible and likely.

German Government Adopts FDI Emergency Measures with Focus on Healthcare Sector

By Peter Camesasca, Horst Henschen, Sarah Hachmeister and Martin Juhasz on April 29, 2020 Posted in COVID19, Pharmaceutical companies

On 28 April 2020, the German government published a ministerial draft for an amendment of the Foreign Trade and Payments Ordinance (“Draft Ordinance”). The amendment supplements the existing Foreign Direct Investment (“FDI”) regime in order to tighten it with respect to acquisitions of critical companies in the healthcare sector by purchasers from third countries. The Draft Ordinance comes shortly after the German government proposed a new draft bill on 31 March 2020 reforming the current Foreign Trade Act (the “Draft Bill”). For more information on the Draft Bill please see our previous blogpost.

Peter Altmaier, the German minister for economic affairs stated that the competent authorities must learn about such critical acquisitions in the healthcare sector early enough to be able to examine them and that the new rules are intended to allow the authorities to prevent a flowing abroad of “medical know-how and production capacity, which are essential for the health care of the population”.

The Draft Ordinance is a direct reaction to the current Covid-19 crisis and will come into force ahead of other, broader amendments to the Foreign Trade and Payments Ordinance that were previously planned in connection with the Draft Bill. These broader amendments to the Foreign Trade and Payments Ordinance can still be expected later this year.

Draft Ordinance Expands the List of Sectors Requiring Mandatory Filing

Under the current FDI regime, the German authorities can investigate acquisitions in any industry sector where an acquisition by a foreign investor poses a threat to public order or security. However, mandatory filing of transactions is only necessary for certain key listed sectors.

The new Draft Ordinance extends the list of those sectors that require a mandatory filing. It further lowers the acquisition threshold from 25% to 10% for transactions within those sectors.

The new sectors include the development, manufacture or distribution of:

services necessary to ensure the functioning of the German public safety digital radio network;
personal protective equipment (or “PPE”), and including the materials and components required to manufacture PPE – inter alia protective masks (e.g. FFP2 and FFP3 masks), protective gloves or protective suits which ensure the protection of the health and safety of users;
pharmaceuticals that are essential to guarantee the provision of health care of the population, and including the active ingredients for such pharmaceuticals;
medical devices intended for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of life-threatening and highly contagious infectious diseases – inter alia surgical masks and respirators; and
in vitro diagnostic medical devices used to provide information on physiological or pathological processes or conditions or to establish or monitor therapeutic measures in relation to life-threatening and highly contagious infectious diseases – inter alia diagnostic tests for the detection of an infectious agent.

Additional Clarifications

The Draft Ordinance further clarifies some existing FDI rules, including the following:

Regarding the application of FDI screening to asset deals, the Draft Ordinance clarifies that FDI screening also applies to asset deals, in particular, where the acquisition includes (i) separable business units or (ii) essential business resources, which are required to maintain the operation of the undertaking or a separable part of it.
In examining whether an acquisition by a foreign investor poses a threat to public order or security, the Draft Ordinance introduces a new provision (similar to Article 4(2) EU FDI Screening Regulation), allowing the German regulator to take into account the specific characteristics of the investor. This may include, for instance, whether the foreign investor is directly or indirectly controlled by the government, including state bodies or armed forces, of a third country.

No Expiry Date

Even though the draft ordinance arose in the light of the COVID-19 crisis, it will not have an expiry date. As the Draft Ordinance explicitly states, the new rules also address future crisis situations and aim to maintain the functioning of the public health care sector within Germany at all times.

Observations

The Draft Ordinance introduces new sector categories for which an FDI filing will be mandatory. It should be noted that the Draft Bill amending the Foreign Trade Act proposes to introduce a gun-jumping provision, i.e. a prohibition on implementing transactions prior to receiving a clearance decision, applicable to all transactions for which a filing is required. This gun-jumping provision will also apply to the above-mentioned new categories covered by the Draft Ordinance. As a consequence, acquisitions in the categories listed above will fall under the scope of the gun-jumping prohibition and under the new rules of the Draft Bill, a breach may ultimately result in criminal sanctions.

With the introduction of these new emergency measures, the German government joins a number of other EU countries reacting to concerns relating to takeovers by foreign investors of “critical” companies. While Italy and Spain have adopted emergency matters for a broad range of industry sectors, the German proposal has a clear focus on the health care sector and reserves additional FDI rules covering other sectors for the already expected forthcoming revision of the Foreign Trade and Payments Ordinance.

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

By Sarah Cowlishaw and Anna Herrmann on April 27, 2020 Posted in Food & Drug Regulatory, Medical Devices

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

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

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

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

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

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

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

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

By Maree Gallagher and Marie Doyle-Rossi on April 14, 2020 Posted in COVID19, Food & Drug Regulatory, Medicinal Products

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

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

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

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

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

By Bart Van Vooren on April 10, 2020 Posted in COVID19, Export, Food & Drug Regulatory, Pharmaceutical companies

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

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

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

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

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

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

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

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

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

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

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

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

By Wesley Lepla, Bart Van Vooren and Loïc Waty on April 10, 2020 Posted in Competition, COVID19, European Union, Food & Drug Regulatory, Medicinal Products

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

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

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

The purpose of the Framework is to:

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

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

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

Main criteria for the competition assessment of cooperation projects

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

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

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

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

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

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

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

Exceptional procedure to obtain ad hoc guidance on specific cooperation projects

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

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

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