7 Transparent pricing of medicines
| Committee's assessment
| Politically important |
| Committee's decision | Cleared from scrutiny
|
| Document details | Amended draft Directive on the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems
|
| Legal base | Article 114 TFEU; co-decision; QMV
|
| Department
Document numbers
| Health
(34781), 7452/1/13, COM(13) 168
|
Summary and Committee's conclusions
7.1 The so-called "Transparency Directive", adopted
in 1989, establishes minimum procedural safeguards to ensure that
national cost-containment measures to regulate the pricing of
medicines and determine whether they qualify for public funding
are taken in an open and transparent manner and do not constitute
an unwarranted restriction on the free movement of goods. It does
so by requiring Member States to take decisions on pricing and
reimbursement within specific time limits ranging from 90 to a
maximum of 180 days, provide reasons for their decisions which
are based on objective and verifiable criteria, and ensure that
legal remedies are available in the event of a negative decision.
7.2 The Commission considers that the 1989 Directive
has helped to create "a basic culture of transparency"
in the pricing and reimbursement mechanisms developed by Member
States, but that it has not kept pace with new challenges arising
from the evolution of the pharmaceuticals market over the last
two decades. It therefore proposed a new Directive in March 2012
which retained the core principles of the 1989 Directive but sought
to introduce some new elements. These included shorter time limits
for pricing and reimbursement decisions, intended to give patients
quicker access to medicines and to allow innovative pharmaceutical
companies to reap the full benefits of market exclusivity for
their newly patented medicines, as well as new powers to impose
penalties and award damages for exceeding the prescribed time
limits for reimbursement decisions determining whether a particular
medicine would be funded by a national health insurance scheme.
7.3 Discussions within the Council proved to be difficult
and, in March 2013, the Commission presented an amended proposal
which included:
· longer
time limits for pricing and reimbursement decisions;
· a revised
remedies procedure and the removal of contentious provisions on
penalty payments and damages; and
· less
onerous reporting requirements for Member States' competent national
authorities.
7.4 The Government indicated that the revised proposal
addressed many of its concerns but that it would nevertheless
seek clarification of a number of provisions and remain vigilant
to the risk of competence creep. We decided to clear the Commission's
original proposal from scrutiny but to retain the amended draft
Directive under scrutiny. We asked the Government to explain how
it would affect the new pricing and cost containment arrangements
for branded medicines which it intended to introduce in 2014,
including Value Based Pricing.
7.5 In his latest letter, the Minister for Life Sciences
(George Freeman) explains that the Commission has withdrawn its
proposals.
7.6 We note that the Commission's proposals to
amend the 1989 Transparency Directive are to be withdrawn. Accordingly,
we clear the draft amended Directive from scrutiny.
Full details of
the documents: Amended
draft Directive of the European Parliament and of the Council
on the transparency of measures regulating the prices of medicinal
products for human use and their inclusion in the scope of public
health insurance systems: (34781), 7452/1/13, COM(13) 168.
Background
7.7 Our Reports listed at the end of this chapter
provide a more detailed overview of the Commission's original,
and amended, draft Directive and the Government's position.
The Minister's letter of 3 February 2015
7.8 The Minister informs us that the Commission's
proposal to amend the 1989 Transparency Directive features in
the list of measures for withdrawal which forms part of the Commission
Work Programme for 2015. The reason given by the Commission for
its withdrawal is "no foreseeable agreement".
7.9 The Minister notes the lack of progress made
in Council working group discussions since 2013. At the last meeting,
in June 2014, he adds:
"A number of Member States continued to
raise significant concerns about the amended proposal, particularly
relating to issues of subsidiarity and proportionality, and because
it was felt to be imposing a one-size-fits-all approach to varied
national pricing and reimbursement policies. The UK position had
remained more positive than those of most other delegations, although
we also had some major concerns that still needed to be addressed,
such as about the time limits for decisions on pricing and how
these are calculated.
"Whilst progress had been expected with
the Italian Presidency of the Council, none of [the] meetings
that had been scheduled since June 2014 took place."
Previous Committee Reports
Fortieth Report HC 86-xxxix (2012-13), chapter 6
(24 April 2013); Our Sixty-third Report HC 428-lvii (2010-12),
chapter 3 (18 April 2012) and our Fourth Report HC 86-iv (2012-13),
chapter 11 (14 June 2012) are also relevant.
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