Ref. Ares(2018)474759 - 26/01/2018
Ref. Ares(2019)631504 - 04/02/2019
Läkemedelsindustriföreningen (LIF) is highly concerned by the current approach of the
Commission in the discussions around a “manufacturing waiver” for Supplementary
Protection Certificates, the potential negative effects of such a waiver and the discussions
within the Commission around revision of patent protection for pharmaceuticals.
Stockholm 180126
Dear Honourable Commissioner,
Dear Ms. Bieńkowska,
On behalf of
Läkemedelsindustriföreningen, LIF (The Swedish Association of the Pharma-
ceutical Industry), I am writing to you regarding an issue that will have a significant impact
on Swedish and European industries in general. LIF is the trade association for the re-
search-based pharmaceutical industry in Sweden, with about 90 members and associate
companies, who represent approximately 80 percent of the total sales of pharmaceuticals in
Sweden. We are highly concerned about the discussions within the Commission regarding
the potential revision of patent protection for pharmaceuticals, particularly the so-called
supplementary protection certificates (SPCs).
We are worried about European Commission proposals being considered to limit patent
extension terms (SPCs), by permitting generic and biosimilar companies to manufacture
products for export – a so-called export waiver – as well as to stockpile products – a so-
called stockpile waiver – whilst the duration of a SPC term is still on-going. We believe
that in the current situation a legislative proposal to amend European patent protection
would infringe the Better Regulation principles by which the European Commission has
vowed to act in its policymaking. In addition, we believe that the introduction of such
patent exemptions would not be compatible with the EU’s trade policy, as it would run
counter to the provisions set out in Free Trade Agreements with the EU’s trade partners.
A study by Charles River Associates (CRA) was commissioned by the European Commis-
sion and claims that the intended revision of the patent incentives and rewards framework
will result in a strengthened pharmaceutical sector. In our opinion, this study is based on
unrealistic assumptions and omits important assessments that are essential for a holistic
policy.
The economy of the EU and its Member States, including Sweden, is highly dependent on
its innovation power. Exceptions to the SPC will give a wrong signal and certainly lead to
a reduction of innovation incentives of originators and could ultimately impact patient
health. As an innovation-driven country Sweden has a lot to lose if the potential long-term
and secondary effects are not sufficiently evaluated or even disregarded. Our member
companies have built their strategies on the condition of longstanding security, based on
patent protection. The investments in the pharma and research-based industries are high-
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risk and long-term; the only way to sustain them is to offer certainty in the returns and the
ability to continue the investments in the future.
This is secured by the intellectual property rights framework that currently exists in Eu-
rope, in particular due to SPCs. Picking this important framework apart puts at risk the
Swedish research strategy, as the incentives that companies were previously benefiting
from and that encouraged them to continue engaging in the long-winded and very costly
research and development of medicines will no longer exist. In the long run this will result
in lower investments into research and thus fewer medicines being made available for pa-
tients.
Our strong view is that the issues require further reflection and that the current legislation
should not be changed. As a first step other less intrusive mechanisms could be considered.
This was unfortunately omitted from the Commission’s consultation. Successful national
policies of Member States should be used an as example; such as France, where a waiver
has a soft-law approach.
Any future SPC reform should in any case be done in a holistic way. Any imbalanced
change of the IP framework would have profound implications and dangerous unintended
consequences, such as uncontrollable spill-overs to other parts of the patent framework. In-
stead the Commission should focus on incentivizing and boosting innovations for Swedish
and European companies and research activities in general. Policy action in this sector
needs to be based on a solid assessment of all options available as well as the real implica-
tions for research into new medicines, society and patients across the EU.
Yours sincerely,
Director General, LIF
Läkemedelsindustriföreningen (LIF)
CC:
Vice-President Jyrki Katainen
Commissioner Cecilia Malmström
Electronically signed on 04/02/2019 15:18 (UTC+01) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563