Life Science Update: May 2022

EU update

European Commission puts forward a proposal for the European Health Data Space

On 3 May 2022, the European Commission put forward a proposal for a regulation on the European Health Data Space (EHDS), the first common EU health data space, for citizens and science. The EHDS is intended to enable citizens to control and utilise their health data and to create a strong legal framework for the cross-border use of health data for research, public health, policy-making and regulatory purposes. According to the Commission, the EHDS will ensure full compliance with EU's high data protection standards.

The EHDS aims at providing EU citizens easy access to their health data and enabling them to add information, rectify wrong data, restrict access to others and obtain information on how their data is used and for which purpose. Moreover, citizens will be able to share health data with other health professionals in and across member states.

According to the proposal, member states must ensure that patient summaries, electronic prescriptions, images and image report, laboratory results and discharge reports are issued and accepted in a common EU format just like each member state must designate a digital health authority, a market surveillance authority and one or more health data access bodies.

Researchers', companies' and institutions' access to health data will require a permit from a health data access body and will only be granted for specific purposes without revealing the identity of the individual.

Read the European Commission's press release here and access the proposal here.

Denmark Update

New 4-year pilot programme on reimbursement of medicines on shared risk basis

On 21 April 2022, the Danish Parliament adopted a bill to introduce a new 4-year pilot programme on reimbursement of medicines based on shared risks. The intention is to continue the main elements of the previous 3-year reimbursement pilot programme which ended on 31 December 2021, and which did not provide sufficient basis for deciding whether the programme should be made permanent. The new pilot programme will enter into force on 1 June 2022 and expire on 1 June 2026.

The pilot programme allows the Danish Medicines Agency to grant general conditional reimbursement of prescription-only medicines based on shared risks. Under the previous pilot programme, the Danish Medicines Agency granted reimbursement of two prescription-only medicines.

General conditional reimbursement of prescription-only medicines based on shared risks means that the public health services will cover the expenses for reimbursement to a specified number of patients that meet the reimbursement criteria (the target population) while the pharmaceutical companies that put the medicines on the Danish market will cover the public health services' expenses relating to reimbursement to the number of patients exceeding the target population. The target population will be defined by the Danish Medicines Agency in connection with each application.

The Danish Medicines Agency will only grant general conditional reimbursement of prescription-only medicines based on shared risks where the risk of inexpedient first choice is mainly caused by economic considerations.

Read the bill as adopted here (in Danish).

Proposal to abolish taxes on phantom income

On 1 March 2022, a proposal for a parliamentary resolution to abolish taxes on so-called phantom income was put forth by a parliamentary majority. According to the proposal, the Danish Parliament will order the Danish Government to present a revenue-neutral model that entails abolishment of the so-called phantom tax, according to which shareholders must pay taxes for unrealized profits that they have not yet received but may receive by agreement on milestone payments in connection with a sale of the company. Instead, sellers of unlisted companies must pay tax on an ongoing basis as they receive their milestone payments.

The proposal may have a huge impact on the Danish life science industry, in particular biotech, where milestone payments are common, seeing that the development of medicinal products etc. requires a lot of capital to carry the product through the late development phases, and the chances of success are low.

The proposed parliamentary resolution can be accessed here (in Danish).

Adjustment of fees for medicinal products and pharmaceutical companies etc.

On 1 May 2022, a new Executive Order on Fees for Medicinal Products and Pharmaceutical Companies entered into force. The Executive Order regulates i.a. fees for authorisation of medicinal products and authorisation to handle medicinal products, etc.

While the Danish Medicines Agency's area of responsibility under the Danish Medicines Act is fully fee-financed, the fees have not been adjusted since 2017. According to the Executive Order, all fees have been adjusted upwards to a total of DKK 34 million per year. The Danish Medicines Agency currently has a DKK 12.5 million deficit under the Danish Medicines Act, primarily caused by increasing IT depreciations in connection with the necessary implementation and development of a medicinal products database called LEOPARD. The deficit has further been caused by a decrease in the fee income in recent years as a result of deregistration of marketing authorisations, which has not been offset by a decrease in the Danish Medicines Agency's tasks.

The Executive Order can be accessed here (in Danish).  

Proposal to establish Health Clusters and a Health Cooperation Committee

On 29 April 2022,  a bill to amend the Danish Health Act by introducing health clusters and a Health Cooperation Committee was presented to the Danish Parliament. The bill implements an agreement entered into by the Danish Government, the Danish Regions and KL - Local Government Denmark on 11 June 2021.

The basis for the agreement is the challenges that the Danish healthcare system is facing due to the demographic development, which i.a. means more elderldy people and more patients with chronic diseases. The parties agree that part of the solution to these challenges is to improve collaboration between political parties in every region and to establish health clusters around every acute hospital in the country.

The aim of the establishment of health clusters is to ensure better cooperation between regions, municipalities and general medical practice in public health matters as well as to handle more high-quality tasks in the immediate environment of the citizens and free up resources for patient treatment in hospitals.

Existing regional Health Coordination Committees and Practice Plan Committees will be replaced by a single Health Cooperation Committee to simplify and strengthen current structures of political cooperation. The Health Cooperation Committee will in discussions, when relevant, involve general medical practice representantives as well as representatives of patients and relatives.

The bill is expected to enter into force on 1 July 2022. The bill can be accessed here (in Danish).

The Danish Ministry of Health presents new Healthcare Reform

In March 2022, the Danish Ministry of Health presented a new Healthcare Reform with the following three focal points: i) a new direction for prevention of illness, ii) strengthened quality in local healthcare system and iii) increased amount of time spent on each patient.

One of the main initiatives of the reform is to prevent the new generation (born in or after 2010) from using nicotine products as well as to substantially reduce the intake of alcohol by children and young people (e.g. by raising the minimum age for purchasing alcohol to 18 years. Further, the Danish Government will establish a Centre for Healthy Weight and Well-Being together with the Novo Nordisk Foundation. Moreover, the Government will establish up to 20 local hospitals across the country to support patients with a need for simple diagnostics, patients with chronic diseases and elderly medical patients in particular.

The Health Clusters mentioned in the insight above are part of the reform.

Read more about the new Healthcare Reform here (in Danish).

The Danish Medicines Agency presents new strategy

In April 2022, the Danish Medicines Agency presented a new strategy for the period 2022-2026 as part of its vision to lead national and international collaboration, for example regarding better use of data and new technology and dialogue with citizens and the society in general.

The strategy has the following four strategic benchmarks: i) value-adding knowledge-sharing and administrative processes, ii) better use of data and new technology, iii) international involvement, and iv) great place to work.

As regards item iii), the Agency will increase its influence in relevant international forums to improve the framework for development and use of medicines and medical devices as well as to strengthen and expand its bilateral collaboration.

Read more about the Danish Medicines Agency's strategy here and here (available both in Danish and English).