Sarantis Michalopoulos | EURACTIV.com
Several
pharmaceutical companies in Greece have threatened to stop supplying the
market with innovative drugs and said they could even withdraw existing
drugs as a result of an obligatory “rebate” imposed by the Greek government and
applied retroactively.
EURACTIV.com
has learnt that pharmaceutical companies based in Greece have contacted the
ministry of health to issue a warning about their development of new innovative
drugs as well as the future provision of therapies already available on the
market. The reason
for this, pharmaceuticals claim, is a measure recently introduced by Athens as
part of the bailout deal with its international lenders, hitting the pharma
industry with an up to 25% levy on the turnover generated by new
patent-protected drugs.
This rebate
has been applied to all innovative drugs retroactively from January 2017.
In addition
to this, the Greek government decided in May 2017 to impose a 25% market entry
fee on new medicines. The
pharmaceutical companies claim that they are under pressure from their
headquarters abroad to stop providing innovative drugs and therapies and warn
that patients will likely face a lack of access to specific medicines as a
result of these measures. Athens’
decision to claim the European Medicine Agency’s relocation from London sends a
message that medicine is “not just a commodity but a social good”, Greece’s
Alternate Minister of Foreign Affairs, Georgios Katrougalos, told EURACTIV.com.
No one is
‘forced’
EURACTIV
contacted the National Organisation for Healthcare Provision (EOPYY), Greece’s
health care insurance system, for a comment. EOPYY sources said that the
Ministry of Health had made the decision on the rebate.
The same
sources explained that the pharmaceutical companies have two options: either
refer to EOPYY’s negotiation committee and work for an improved,
mutually-accepted deal to avoid the up to 25% rebate; or pay the 25% on the annual
turnover as demanded by the law.
“These
measures do not exist only in Greece but in all EU member states.”
“EOPYY does
not force any company to bring innovative drugs to the market if it does not
want to, […] however EOPYY ensures patients’ access to innovative healthcare
when needed,” the sources pointed out.
“In the
cases where a doctor decides that a patient needs a medicine that is not on the
market, then EOPYY ensures access to it,” the sources emphasised.
The clawback
Greece finds
itself in a tricky position on the issue of drugs because of the financial
commitments it has taken to save its economy from collapse.
In addition
to rebates and as part of the bailout deal, Greece introduced another provision
in 2012, the clawback, as a “temporary” mechanism aiming to reduce public
spending on hospital healthcare, whose budget has remained stable at €1.9
billion over the last three years.
As the
country’s total pharmaceutical expenditure exceeds the budget, pharmaceutical
companies are asked to repay the excess.
The logic
behind the introduction of this mechanism suggests that the current consumption
of prescription drugs is inconsistent with the real medical need. Consequently,
the budget overrun must stem from over-prescription of pharmaceutical preparations
or other possible shortcomings of the healthcare system.
The clawback
calculation is based on the market share as well as the development of each
company. This means that if a pharmaceutical company’s sales grow in line with
medical demand, then its bill to the state also increases.
Commission’s
dual language
EURACTIV has
recently contacted the European Commission on the clawback issue. The executive
has always defended its pro-public health policies when it comes to austerity
measures in countries under bailout programmes.
“The
clawback mechanism operating in Greece allows the authorities to control the
costs associated with their pharmaceutical reimbursement budget while
ensuring that patients continue to have access to the medication they need,” an
EU spokesperson said.
“The
decision on the type of medicines covered by this mechanism falls under the
responsibility of the Greek authorities,” the spokesperson added.
Background
Hit hard by
austerity, the health systems of EU member states are under huge pressure.
Combined with an aging population and the alarming burden of chronic illnesses,
EU member states have targeted specific aspects of the incentives granted to
the pharma industry in order to decrease drug prices.