Life Science Update: December 2022

Denmark update

Guidelines on admission of products to medicinal cannabis pilot programme

On 16 September 2022, the Danish Medicines Agency published draft new guidelines for the admission of cannabis products produced in Denmark to the Agency's list of cannabis intermediate and primary products that are included in the pilot programme for consultation. The guidelines were intended to enter into force on 15 November 2022, but the process has been delayed due to the number of consultation comments. The current expectation is that the guidelines will be published by the end of this year.

The guidelines contain additional guidance on and supplementary directions to the rules specified in the Act on a Medicinal Cannabis Pilot Programme and on the scheme for Cultivation, Production, etc. of Medicinal Cannabis as well as the additional rules in the ancillary executive orders. Generally, the guidelines provide an overview of the rules on admission of cannabis products produced in Denmark in the pilot programme, describing the practice for admission and providing practical instructions on applying for admission and the documentation to be filed in that connection.

Access the draft guidelines here (in Danish).

Updated process for the Danish Medicines Council's assessment of medicinal products

The Danish Medicines Council (DMC) has recently updated its process for assessing new medicinal products. Pharmaceutical companies can now, to a greater extent, apply the DMC for assessment of a new medicinal product through direct listing in treatment guidelines. Until now, that has only been possible for medicinal products that were as good as medicinal products that had already been given equal status in the relevant treatment guidelines.

Previously, pharmaceutical companies with new medicinal products that could not be given equal status, e.g. due to safety reasons, had to apply the DMC for a recommendation as a first step, even if the DMC already had treatment guidelines on the area. Following that, the companies had to await that their products were listed in the treatment guidelines when they were subsequently updated. Now there is one process for both recommendation and listing in the treatment guidelines.

With the updated process, it will be possible for more medicinal products to be assessed which has been requested by both the DMC and pharmaceutical companies. Medicinal products that are expected to be better than the existing standard treatment in Denmark will, however, still need to be assessed through the normal process for new medicinal products.

The DMC is currently preparing a specific application scheme for the updated process.

Read more about the updated process here (in Danish).

Revised practice guide on use of digital media in advertising activities

Following the Ethical Committee for the Pharmaceutical Industry in Denmark's (ENLI) revisions to its practice codes and guidelines earlier this year, ENLI has published a revised guide regarding use of digital media in advertising activities.

Besides amendments in light of the Guidelines on Advertisement of Medicinal Products by the Danish Medicines Agency that entered into force in April 2022 (see our February 2022 Life Science Update), including clarifications to the scope of the advertising concept, guidance on the use of influencers in light of Section 10(1)(vii) of the Executive Order on Advertisement (the ban on using persons, etc., who have a special reputation in advertising for medicinal products to the public) and revised guidance on mandatory text in connection with podcasts and videos, the revisions to the guide consist of implementation of the new Joint Note for Guidance on social media and digital channels published by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Both Danish and English versions of the revised guide have been published on ENLI's website. Access them here.

Practice guidance on environment and climate claims in advertisements and continuing education events

The Ethical Committee for the Pharmaceutical Industry in Denmark (ENLI) has, based on different cases, provided some guidance on environment and climate claims in advertisements for medicinal products and continuing education in its newsletter of 16 September 2022.

As regards advertising activities, environment and climate may be used in comparative advertising on the condition that it is used as secondary and supplementary information to other professionally relevant information about the medicinal product only. Thus, according to the principle of objectivity set out in Section 4(2) of the Promotion Code, advertisements for medicinal products must primarily be based on information about the medical efficacy of the product, including its safety profile.

When it comes to continuing education events, pharmaceutical companies presenting reports or giving presentations on e.g. environment or climate subjects must fulfil the requirement on substantiation of information on medicinal products stipulated in Section 7(5) of the Promotion Code if the reports or presentations can be perceived as indirect advertisement of their medicinal products.

Access ENLI's newsletter and the guidance described here (in Danish).

Danish Health Technology Council withdraws requirement of cost neutrality

On 28 November 2022, the Danish Health Technology Council (DHTC) announced that the board of directors of Danish Regions had approved DHTC's recommendation to withdraw the requirement of cost neutrality from their evaluation process. This means that companies no longer have to meet the requirement of cost neutrality when they apply for an evaluation of their products by the DHTC. The hope is that more companies will apply for such evaluation following the change.

An evaluation may lead to a positive recommendation which means that the health technology in question will be implemented in the regions. Until now, companies have not been able to apply for such evaluation themselves if their technology were more expensive that the existing alternative. Instead, a hospital or a region could apply.

The change in the DHTC's evaluation process takes effect immediately, and their process handbook is expected to be updated in December 2022.

Access the DHTC's announcement here (in Danish).

Amendments to Executive Order on Registration, Notification and Supervision of Public Treatment Facilities, etc.

On 30 September 2022, the Danish Patient Safety Authority published a draft amendment of the Executive Order on Registration, Notification and Supervision of Public Treatment Facilities, etc., for consultation. The amendment carries changes and clarifications to the existing executive order on the area.

In addition to other things, the amendment clarifies that:

• A treatment facility which receives a new company registration (in Danish: "CVR") number is considered a new treatment facility that must be registered with the Treatment Facility Register.
• Public treatment facilities are considered new treatment facilities when given a new production entity number (P number), e.g. in connection with change of address.
• Cosmetic treatment facilities are required to register with the Treatment Facility Register regardless of annual revenue. Therefore, cosmetic treatment facilities that have previously been exempted from this rule due to the level of their annual revenue must now register.

Furthermore, the Danish Patient Safety Authority's practice allowing the Authority to make corrections to the fees collected for up to three years retrospectively has now been clarified.

The deadline for submitting comments was 28 October 2022, and the amended executive order is expected to enter into force on 1 January 2023. Access the draft amendment here (in Danish).

Amendments to health research framework

On 3 October 2022, a draft bill to amend the Danish Act on Research Ethics Review of Health Research Projects and the Danish Health Act was published by the Danish Health Authority for consultation.

The draft bill aims at providing a more flexible framework for health research, more information and self-determination for patients as well as trial subjects, a National Research Overview database and the Danish Health Data Authority's surveillance and analysis function in the health sector.

The draft bill contains the following six parts:

1. Use of prospective data for research; to emphasise that the National Science Ethics Committee can authorise health data research projects with access to sensitive bioinformatics prospective data on an ongoing basis.
2. More information and greater self-determination for patients and trial subjects; to enable the committee system to require - in connection with applications for exemption from the consent rule - that the responsible investigator informs the patients and trial subjects about the concrete research project that takes place, including how these individuals can withdraw from the project.
3. National Research Overview; a new report-based database under development which is intended to function as a public database with information on reported and approved projects.
4. Hypothesis-generated research projects; to include guidance on the Committee's evaluation of exploratory studies of extensive amounts of data to generate new hypotheses in health science.
5. More information and greater self-determination in research of genomic data; as for 2) above, to enable the committee system to require - in connection with its evaluation of a health data scientific project regarding sensitive bioinformatics data - that the responsible investigator informs the patients and trial subjects about the concrete research project that takes place, including how these individuals can withdraw from the project.
6. Central surveillance and analysis functions in the health sector by the Danish Health Data Authority; to clarify that the Danish Health Data Authority carries out surveillance and analysis tasks to support other tasks of the Authority.

The deadline for providing comments was 28 October 2022, and the bill is expected to enter into force on 1 July 2023. Access the draft bill here (in Danish).

Guidelines on data protection right roles in research projects for Danish regions and universities

A legal task force consisting of Danish Regions, the five Danish regions and the health science faculties of the University of Copenhagen, the University of Southern Denmark, Aalborg University, and Aarhus University was established in the end of 2021 with the aim of ensuring better conditions for health research in Denmark. The task force has now prepared a common set of guidelines on how the responsibility for health data is to be divided in research projects. The guidelines are intended to lead to a uniform and more rapid consideration of research applications for the benefit of the patients.

Primarily targeted at legal advisors and case workers engaged in health research, the guidelines contain guidance on how the responsibility for data in research projects is to be divided and what agreements to that effect are to be entered into between the regions and universities. The guidelines apply only to clinical health research on behalf of the Danish regions and the four involved universities.

The guidelines can be accessed here (in Danish).

EU update

The European Commission intends to extend the MDR Transition Period

On 9 December 2022, the Commissioner for Health and Food Safety announced an intention to the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) to extend the transition period under the Medical Devices Regulation ((EU) 2017/745) (MDR) for three more years. The MDR entered into force on 26 May 2021 with an initial three-year transition period and carries changes to i.a. the certification process for medical devices in the EU.

The reason for the wish to extend the transition period is mainly due to delays in the certification process caused by increasing costs and time periods for the conformity assessments and the small number of designated notified bodies compared with the high number of medical devices requiring recertification to transition to the MDR.

According to a note from the General Secretariat of the Council, the likely elements of a legislative proposal amending the MDR could include the following extended transition periods for medical devices approved under the Medical Device Directive (93/42/EEC) (MDD):

• 2017 for risk class III and IIb devices (i.e. devices with a higher risk)
• 2018 for risk class IIa and I devices (i.e. devices with a lower risk) that need the involvement of a notified body in the conformity assessment

The European Commission suggests that certain conditions are introduced for manufacturers to benefit from the extended transition periods to ensure that they apply only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR before a certain deadline, e.g. 26 May 2024.

The legislative work is intended to be initiated in the beginning of 2023 and will be discussed by the European Parliament and Council. In addition to the proposed legislative amendments, the European Commission intends to undertake a comprehensive evaluation of the MDR by May 2027.

Access the note from the General Secretariat of the Council with the likely elements of the legislative proposal here.

Judgments by the Court of Justice of the European Union on the interpretation of the rules on falsified medicinal products in respect of parallel import

On 17 November 2022, the Court of Justice of the European Union (CJEU) issued judgments in three cases between manufacturers of medicinal products and parallel importers (C-147/20 (Germany), C-204/20 (Germany) and C-224/20 (Denmark)) on the ability of trademark owners to oppose the marketing by a parallel importer of repackaged medicinal products.

The cases were triggered by the Regulation on the packaging of medicinal products ((EU) 2016/161) of 2 October 2015 which supplements the Falsified Medicines Directive ((EU) 2011/62) of 8 June 2011 and was implemented in 2019. The new rules have introduced additional safety features, including a unique 2D barcode and an anti-tampering device (a safety seal), which parallel importers have used as an argument to be allowed to repackage medicinal products in order to avoid having to relabel original packaging when replacing e.g. package leaflets in national language to comply with local regulations in the import market and anti-tampering devices.

In short, the CJEU ruled that a trademark owner is entitled to oppose the marketing by a parallel importer of a medicinal product repackaged in new outer packaging to which the trademark is affixed where the replacement of the anti-tampering device of the original outer packaging would leave visible or tangible traces of that original outer packaging having been opened, provided that (i) there is no doubt that those traces of opening are attributable to the repackaging of that medicinal product by that parallel importer and (ii) those traces do not cause, on the import market or on a substantial part of it, such strong resistance from a significant proportion of consumers to the medicinal products repackaged in that way that it would constitute a barrier to effective access to that market.

Access the Court of Justice of the European Union's judgments in the cases here (C-147/20), here (C-204/20) and here (C-224/20).