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Op-Ed
Sabrina Röttger-Wirtz
“The Commission presents the EU’s Pharmaceutical
Strategy: a paradigm shift?”
www.eulawlive.com
Suggested citation: Sabrina Röttger-Wirtz, “The Commission presents the EU’s Pharmaceutical Strategy: a paradigm
shift?”, EU Law Live, 30 November 2020
“The Commission presents the EU’s Pharmaceutical
Strategy: a paradigm shift?”
Sabrina Röttger-Wirtz1
Presenting a Pharmaceutical Strategy for Europe
in the middle of a pandemic has moved the
European Commission into the spotlight in an
area that otherwise is probably more of a niche
topic in the EU law and policy community. Still,
it should be clarified that the Pharmaceutical
Strategy is not a reaction to the COVID-19 crisis:
many of the action points contained in the
Strategy can be traced back to the mission letter
that President von der Leyen provided
Commissioner Kyriakides with in September
2019. However, while reforms of the regulatory
framework were to be expected, the COVID-19
pandemic has certainly been a catalyst for the
Commission initiatives in this area.
The key action points of the Pharmaceutical
Strategy are not surprising for those that have
followed the debates in EU pharmaceutical law
and policy in the recent years. To summarise the
areas of concern: accessibility of medicines;
antimicrobial resistance (AMR); pharmaceutical
industry competitiveness and innovation
facilitation; regulatory efficiency; supply chain
dependence; and environmental risks. These
topics were also raised in the 2017 European
Parliament Resolution on options for improving
access to medicines and the 2018 European
Parliament Resolution on Antimicrobial
Resistance.
The first challenge identified in the Strategy is
accessibility to medicine, and the Commission
has identified several aspects that require
improvement. First of all, the Commission made
clear that it sees the need to foster and steer
innovation in areas of currently unmet medical
need – this refers to the lack of medicines for
certain rare diseases as well as neglected patient
groups like children, senior citizens and pregnant
or breastfeeding women. This also became
evident in the evaluation of the respective legal
measures currently in place, as published in
August. Without regulatory interference there is
little economic incentive to develop these
products and the currently existing incentives
have been successful only in certain therapeutic
areas. An Inception Impact Assessment has
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already been published for the revision.
Additionally, a problem of the current regulatory
framework is that medicines, even though they
obtained EU-wide marketing authorisations, are
not accessible in all Member States because
companies may choose not to market their
product in certain countries. Here, the
Commission considers making incentives
conditional on improved accessibility.
Other accessibility problems concern the current
debate surrounding excessive pricing of
pharmaceuticals. The competence for
pharmaceutical pricing as an important
component of the organisation of national
healthcare systems lies with the Member States.
Therefore, the Commission in the Pharmaceutical
Strategy mostly focusses on strengthening
cooperation between the Member States and also
aims to make the cost of medicines development
more transparent. It also wants to use public
procurement practices and the enforcement of
competition law to address this issue. Finally, the
Strategy in this context refers to the already
proposed Health Technology Assessments
(HTA) Regulation, which first met resistance in
the Council of the European Union but now
seems to have been reinvigorated by the
pandemic, and aims to strengthen the cooperation
of the Member States in establishing the added
value of a new medicine.
One issue that was already recognised before the
pandemic, but which has been magnified by
COVID-19, is medicines shortages due to
interruptions in the supply chain. Europe is
currently highly dependent on the production of
medicines and their active ingredients in third-
countries and this has already led to shortages in
the past. The Commission in the Strategy
announced that a study to assess the causes of
shortages is underway and that the legislative
framework could potentially be reviewed in order
to place more responsibilities on the industry to
ensure stable supply. In this regard, the Strategy
is not as pronounced as some might have
expected in moving pharmaceutical production
back to Europe.
Along with these more patient-centred
accessibility issues, the Commission also wants
to support innovation and competitiveness of the
EU pharmaceutical industry. In this regard, the
vision of the Strategy is very focussed on
digitalisation and the creation of the European
Health Data Space to be established until 2025.
Furthermore, taking into account the Intellectual
Property Action Plan, the supplementary
protection certificate system will be streamlined.
Main areas of innovation like gene and cell
therapies, personalised medicines and medicines
containing or consisting of GMOs should be
supported through revising the regulatory
frameworks for innovative clinical trials and the
use of real-world data in the assessment process.
Overall, the strategy in terms of the regulatory
procedures in place does not propose radical
changes, but more the increasing of regulatory
flexibility in the face of technological and
scientific progress.
Finally, the strategy promises actions with regard
to the global threat of antimicrobial resistance,
environmental risks caused by pharmaceutical
production and disposal, as well as maintaining a
strong European position in global regulatory
cooperation. Thus overall, the Strategy contains
few surprises and it is also not the start of a
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revolutionary overhaul of the regulation of
pharmaceuticals in the EU. This is a testament to
the efficiency of the framework in place.
However, the Pharmaceutical Strategy does
address existing problems for patients by
promising to fine-tune incentive structures and
revise regulatory approaches to benefit from new
technologies. The Strategy has been welcomed by
the European Parliament, however, the
announced reassessment of the incentive schemes
has raised criticism in the industry.
From a more general EU law perspective the
Pharmaceutical Strategy is interesting, as it
indicates a shift from a pharmaceutical policy that
is driven by the facilitation of the free movement
of goods and strongly emphasised the regulation
of risks with regard to medicinal products, to
questions of accessibility of the products for
patients and the steering of innovation via
incentive schemes. This is not to say that the EU
was not active in these areas before, as the
Regulations for orphan medicinal products and
paediatrics or the proposed HTA Regulation
show. However, it is remarkable how little
internal market and risk regulation concerns
feature in the Strategy and how pronounced the
new patient-centred approach is presented.
The legal basis for the adoption of EU legislation
in the field of pharmaceuticals is to be found in
the internal market provision of Article 114
TFEU, sometimes in conjunction with Article
168(4) TFEU providing for the adoption of
‘(m)easures setting high standards of quality and
safety for medicinal products and devices for
medical use’. This is to be contrasted with the
organisation of health care systems which
remains the competence of the Member States, as
enshrined in Article 168(7) TFEU. The focus on
accessibility in the Strategy and the rethinking of
incentives to steer innovation is thus by no means
self-evident and the Commission is also careful to
emphasise that in many planned initiatives that
the EU action will be limited to supporting
Member State cooperation. Similar competence
questions are raised in the debate surrounding the
European Health Union. However, where the
Pharmaceutical Strategy is indeed seen as a first
step towards the reorientation of the focus of
pharmaceutical policy, it is a paradigm shift and
maybe even an indicator of a maturing of the
regulatory framework.
With regard to the Pharmaceutical Strategy a key
question will be whether and in how far this
reorientation will receive the support of the
Member States. Just to put the re-gained
enthusiasm for EU health competences into
context, in 2017 the European Commission in its
White Paper on the future of Europe in one
presented scenario had included public health as
an area where the EU ‘is perceived as having
more limited added value, or as being unable to
deliver on promises’. Looking at the history of
market integration for pharmaceuticals and also
the resistance that the HTA Regulation proposal
has met in the Council before the pandemic,
health law in general and pharmaceutical law in
particular are politically and economically
sensitive areas for the Member States. The
question where competences regarding medicines
accessibility and pricing should be allocated is
complex. However, it is clear that the issues that
the Commission raises in the Pharmaceutical
Strategy are far more connected to the
organisation of the healthcare systems of the
Member States than the traditional market and
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risk policy in the pharmaceutical sector. In the
State of the Union Address, President von der
Leyen has said that: ‘it is clearer than ever that we
must discuss the question of health competences.’
Therefore, the progress of the initiatives proposed
in the Pharmaceutical Strategy might provide
some insights into the prospect of the Unions
repositioning in health law in general.
Dr. Sabrina Röttger-Wirtz is an Assistant
Professor of EU Law at the Maastricht Centre for
European Law (Maastricht University), working
on EU risk regulation in the fields of
pharmaceuticals, foods and pesticides.
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