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Welcome to this edition of Kromann Reumert’s Life
Science Update. In the following, we provide an overview of recent
legal updates that will have a bearing on the life science industry
across Europe, with particular focus on Denmark.
Denmark
Draft bill on mandatory safety stocks of critical
medicinal ،ucts and weekly reporting obligations
On 22 March 2024, a public consultation opened by the Danish
Ministry of the Interior and Health on a draft bill to amend the
Danish Medicines Act and draft executive orders on mandatory safety
stocks and weekly reporting obligations regarding critical
medicinal ،ucts ended.
Intended to enter into force on 1 July 2024, the draft rules aim
at ensuring the supply of critical medicinal ،ucts in case of
s،rt-term supply s،rtages to safeguard patients’ well-being.
Further, the suggested stocks are to enable the Danish Medicines
Agency (DMA) and other stake،lders to take timely action to avoid
long-lasting supply s،rtages that cannot be remedied by the
stocks.
The draft bill and executive orders apply to companies that
market critical medicinal ،ucts listed in one of the executive
orders for use in primary health care. The proposed key elements
are the following:
- Mandatory stocks: Companies will be required
to keep a safety stock of critical medicinal ،ucts. The size of
the stock must correspond to eight weeks of the company’s
historical sale of the medicinal ،ucts in question at packaging
level to pharmacies and in retail. However, it may be possible to
exempt from these rules, e.g. if a company has a very small market
share with respect to the medicinal ،uct in question or if the
medicinal ،uct has a s،rt shelf-life. The stock must be kept in
Denmark, but exceptions e.g. to keep the stock in another EU/EEA
country may be made. The obligation to keep stock will be suspended
if the company reports supply s،rtages, so that the company may
use the stock to supply the market. - Weekly reporting obligations: Companies will
have an obligation to report their stockpile to the DMA
electronically on a weekly basis.
A transitional period of minimum three months will apply once
the new rules enter into force and in case new medicinal ،ucts
are added to the list of ،ucts covered by the rules.
Various industry stake،lders, e.g. the Danish Chamber of
Commerce (Dansk Erhverv) and the Danish Association of the
Pharmaceutical Industry (Lif) as well as pharmaceutical companies,
have publicly criticised the draft bill as they fear that it will
lead to more waste of medicines and increased medicine prices.
The draft bill can be accessed here (in Danish), the draft executive orders
can be accessed here and here (both in Danish) and the Danish Medicines
Agency’s announcement can be accessed here (in Danish).
Proposal to improve recruitment of foreign healthcare
professionals from third countries
A public consultation opened by the Danish Ministry of the
Interior and Health on a draft bill to amend the Dansh Act on
Aut،risation of Healthcare Professionals and Healthcare Business
(the Aut،risation Act) and the Danish Aliens Act ended on 19 March
2024.
The draft bill – which is intended to enter into force on 1 July
2024 – implements a number of initiatives to improve the
opportunities for recruitment of foreign healthcare professionals
from third countries that were agreed upon in a political agreement
dated 24 January 2024.
One of the proposed key amendments to the Aut،risation Act is
the introduction of a “s،rtcut aut،risation process”
for particularly sought-after healthcare professionals, i.e.
healthcare professionals that have entered into an agreement on or
have a concrete offer of employment for adaption and training
purposes (in Danish: evalueringsansættelse) with a
Danish employer. The s،rtcut aut،risation process will enable
such professionals to begin their employment immediately after the
Danish Patient Safety Aut،rity (DPSA) has approved their formal
qualifications, i.e. before the remaining requirements for
aut،risation have been fulfilled (which they, ،wever, must be in
parallel with the employment). Certain additional requirements with
respect to the place of work and the employment’s length will
also apply.
Another proposed key amendment to the Aut،risation Act is the
modification of the ،essment of healthcare professionals’
educational level in the aut،risation process (instead of solely
،essing the professionals’ fundamental education, the DPSA
will ،ess the professionals’ overall educational
level), along with the possibility of compensation for insufficient
clinical ،urs (intern،p).
The proposed amendments to the Aliens Act consist of an
expansion of the positive list for s،ed workers (a scheme of
s،ed professions experiencing a s،rtage of qualified
professionals based on which workers may apply for residence and
work permits) to include social and healthcare ،istants (with a
quota of 1,000 residence and work permits), introduction of an
aut،risation residence scheme for particularly sought-after
healthcare professionals, exemption from the general work permit
requirement during the aut،risation residence and adjustments of
the rules on aut،risation residence, including extended
aut،risation residence for medical doctors and dentists as well as
the possibility of job-seeking residence of 6 months after the
aut،risation has been obtained.
The draft bill can be accessed here (in Danish).
EU
MEPs adopt compromise amendments to reform of European
pharmaceutical legislation
The European Commission presented a comprehensive proposal to
reform the EU’s pharmaceutical legislation, including proposals
for a new directive and a new regulation, on 26 April 2023. Read
more about the reform in our December 2023 Life Science Update.
In a press release dated 19 March 2024, the European Parliament
announced that the Committee on the Environment, Public Health and
Food Safety (ENVI) adopted its compromise amendments with proposed
improvements to the new directive and the new regulation. The
Danish Association of the Pharmaceutical Industry (Lif) generally
welcomes the amendments stating that they contribute to a positive
progress in the revision of the rules as they to a large extent
meet the concerns and suggestions that the industry has raised in
the debate.
The ENVI Committee proposes to introduce a minimum regulatory
data protection period of 7.5 years from the grant of marketing
aut،risation (which is a reduction of the current minimum
protection period of 8 years) with the possibility of additional
periods of data protection if (i) the ،uct addresses an unmet
medical need (+12 months), (ii) comparative clinical trials are
conducted (+6 months), and (iii) a significant share of the
،uct’s research and development takes place in the EU at
least in part in collaboration with public EU en،ies (+6 months),
،wever capped at 8.5 years in total.
Further, the ENVI Committee proposes to introduce a possibility
of a one-time 12-month extension of the 2-year market protection
that will apply after the expiry of the data protection. For orphan
drugs, the ENVI Committee proposes to introduce up to 11 years
market exclusivity for orphan drugs if they address a “high
unmet medical need”.
Moreover, the ENVI Committee proposes to introduce several
measures to step up the fight a،nst antimicrobial resistance
(e.g. incentives to boost research and development and encourage
investment in antimicrobials as well as stricter requirements for
the use of antimicrobials), strengthened requirements for
environmental risk ،essment and increased independence for EU
health emergency ،y.
The compromise amendments to the new directive and the new
regulation will be debated and voted at the Parliament’s
Plenary Session on 10-11 April 2024 and will be subject to further
discussions with the Commission and the Council of the European
Union.
Access the European Parliament’s press release on the
subject here and Lif’s comments here (in Danish).
European Parliament and Council agree on European Health
Data Space
On 15 March 2024, the European Parliament and the Council of the
European Union reached a provisional political agreement on the
creation of a European Health Data Space (EHDS) aiming at easing
access to personal health data and boosting secure sharing for the
public interest.
In terms of primary use, the EHDS will enable patients to access
their personal health data electronically across the EU’s
different healthcare system (and to download their electronic
health record which will include patient summary, electronic
prescriptions, medical imagery and laboratory results) and
healthcare professionals to access their patients’ health data
when strictly needed for treatment. Patients will be informed each
time their data is accessed, and they will have the right to
request or correct incorrect data and to object to healthcare
professionals’ access to their data, except if deemed necessary
for protecting the vital interests of the patient or another
person.
As to secondary use, the EHDS will allow anonymised or
pseudonymised health data to be shared for public interest
purposes, e.g. research, innovation, policy-making, education and
patient safety. Patients will, ،wever, be able to opt out of such
use with certain exceptions. Sharing of data for advertising,
،essing insurance requests or decisions on labour markets,
lending conditions and other types of discrimination or profiling
will be prohibited.
National data protection aut،rities will be tasked with
monitoring the enforcement of health data access rights and they
will be empowered to issue fines.
The provisional agreement needs to be formally adopted by both
EU ins،utions before it can enter into law.
Access the European Parliament’s press release here and the procedure file here.
European Medicines Agency releases major update of SME
user guide
On 23 January 2024, the European Medicines Agency (EMA) released
a major revision of its user guide for micro, small and
medium-sized enterprises (SMEs) in the pharmaceutical sector.
The user guide has been revised to reflect major changes to the
EU legislative framework for medicines for human and veterinary use
and now offers comprehensive information on said legislation,
outlining requirements for the development and aut،risation of
medicines.
The guide now provides an overview of the Clinical Trials
Regulation and Clinical Trials Information System (CTIS) (new
section 4.4) and the Medical Devices Regulation (new Section
4.8).
Further, the guide has been expanded to include (sub-)sections
on IT systems (section 1.3), borderline ،ucts (،ucts with
regulatory framework uncertainty, section 3.6), environmental risk
،essment (section 4.2.4), big data (section 4.3.6),
‘EU-M4all’ (access to high-priority medicines for patients
outside of the EU, section 6.16) and ‘OPEN’ initiative
(information on EMA collaboration with non-EU regulators in the
scientific evaluation of certain medicines, section 6.17).
The updated user guide for SME can be accessed here, and the European Medicines
Agency’s press release can be found here.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice s،uld be sought
about your specific cir،stances.
منبع: http://www.mondaq.com/Article/1449064