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National authorities in France and Ireland were due to negotiate
the conclusion of replacement, multi-year pricing agreements with
their respective pharmaceutical industries by mid-2020.
However, where possible, healthcare systems in France and
Ireland are redeploying every financial and personnel resource they
have to mitigating the impact from coronavirus COVID-19. HSE staff
have been re-tasked to COVID-19 related duties and the French
National Authority for Health (Haute Autorité de Santé: HAS), and
the CEPS which is within the Ministry of Health, is also on an
active emergency footing.
A price-setting framework agreement between France's Economic
Committee of Health Products (Comité Économique des Produits de
Santé: CEPS) and the French Pharmaceutical Companies Association
(Les Entreprises du Médicament: LEEM) has already been extended on
two occasions. The terms of the three-year agreement were
originally due to expire on 31 December 2018. Both sides
subsequently agreed to a one-year extension until 31 December 2019
while negotiations continued. A second extension was adopted with
the mutual consent of LEEM and the CEPS in December 2019, with the
extension period scheduled to expire in July 2020. For its part, a
four-year price-reduction agreement between the Irish
Pharmaceutical Healthcare Association (IPHA), the Health Service
Executive (HSE) of Ireland is valid until July 2020. After this
date all agreement obligations shall cease unless continued by
mutual agreement of the parties, given to each other in
advance.
There is evidence from other sectors that COVID-19 has the
potential to cause delays for the pharmaceutical industry. One
testable manifestation of this are slowdowns in clinical trial
activity. A small number of companies have so far halted studies
owing to the impact on trial integrity, deviations in protocol as
well as severe short-term difficulties in recruiting and monitoring
participants effectively.
But multiple other areas of pharmaceutical regulation may
eventually experience similar consequences.
The canary in the coal mine may be how talks on pricing
framework agreements in France and Ireland proceed. Should
negotiations even continue to take place during times of
unprecedented pressure on healthcare systems or will authorities
seek to defer the negotiating process into the second half of 2020?
The pharmaceutical industry also has significant amount at stake.
Aside from the logistical difficulty of avoiding face-to-face
negotiations, and the possibility of COVID-19 infections among key
staff, there is the challenge of how best to present the delivery
of potentially controversial framework deals to the public during a
time of national emergency and what concessions may need to be
offered. The need for a second extension of the LEEM/CEPS multiyear
framework agreement in December was not a positive sign for the
state of the negotiations between the two sides. And it would be an
unparalleled situation for the LEEM and CEPS to opt for a third
extension - taking the total delay beyond 19 months, as of July
2020. Nevertheless regulators and health systems are in
unprecedented times.