# EUR-Lex - 52012PC0084 - EN

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# 52012PC0084

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems /* COM/2012/084 final - 2012/0035 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

·
General context

The legislation of the Union requires a
marketing authorisation to be granted by the competent EU or national authorities
before any medicinal product can be placed on the market.[1] The rules in force aim to
safeguard public health by ensuring that the quality, safety and efficacy of
medicines are properly evaluated before these can be made available to patients
in the European Union. This legislative framework also intends to facilitate trade
in medicines between Member States in accordance with the principle of free
movement of goods.

Meanwhile, pursuant to Article 168(7) of
the Treaty on the Functioning of the European Union, Member States are
responsible for the organisation of their healthcare system and for the
delivery of health services and medical care, including the allocation of
resources assigned to them. In this framework, each Member State can take
measures to manage the consumption of medicines, regulate their prices or
establish the conditions of their public funding. A medicinal product
authorised in accordance with EU legislation on the basis of its quality,
safety and efficacy profile may therefore be subject to additional regulatory
requirements at Member State level before it can be placed on the market or
dispensed to patients under the public health insurance scheme. For instance,
Member States usually evaluate the cost-effectiveness of authorised medicines,
or their relative efficacy as well as the short- and
long-term effectiveness compared to other products in
the same therapeutic class, in order to determine their price, funding and
utilisation in the framework of their health insurance system.

National measures to control the funding of
medicines and manage their consumption in the framework of healthcare systems
are susceptible to create barriers to trade as they affect the capacity of
pharmaceutical companies to sell their products in domestic markets. The
settled case-law of the Court of Justice of the European Union recognises the
right of Member States to adopt such measures in view of promoting the
financial stability of their health insurance system.[2] However, basic conditions of
procedural transparency must be met to ensure their compatibility with the
rules of the Treaty relating to the Single Market. In particular, pricing and
reimbursement measures must be free of discrimination against imported
medicinal products and based on objective and verifiable criteria which are
independent from the origin of the products.

Directive 89/105/EEC[3] codifies the minimum
requirements set forth by the Court of Justice. It was adopted to enable market
operators to verify that national measures regulating the pricing and
reimbursement of medicines do not contravene the principle of free movement of
goods. To this end, the Directive lays down a series of procedural requirements
to ensure the transparency of pricing and reimbursement measures adopted by the
Member States. These obligations include specific time limits for pricing and
reimbursement decisions (90 days for pricing, 90 days for reimbursement or 180
days for combined pricing and reimbursement decisions). The Directive also
requires the competent national authorities to provide a statement of reasons
based on objective and verifiable criteria for each of their decisions and to
provide appropriate legal remedies to the applicant companies.

·
Grounds for and objectives of the proposal

Directive 89/105/EEC has never been amended
since its adoption. Its provisions reflect the pharmaceutical market conditions
which prevailed more than twenty years ago. However, these conditions have
fundamentally changed, for instance with the emergence of generic medicines providing
cheaper versions of existing products or the development of increasingly
innovative (yet often expensive) research-based medicinal products. In
parallel, the constant rise in public expenditure on pharmaceuticals in the
last decades has encouraged Member States to devise more complex and innovative
pricing and reimbursement systems over time.

Despite the historically positive impact of
Directive 89/105/EEC on the internal market for medicines, there is evidence
that it does not fully achieve its objectives in the present context:

–
Firstly, a gap has emerged between the
provisions of the Directive, which describe the main types of pricing and
reimbursement procedures established in the 1980s, and the much wider range of cost-containment
measures adopted nowadays by Member States. Despite the extensive
interpretation of the Directive by the Court of Justice[4], the implementation of its
provisions in national law and the effective enforcement of its principles, in
particular by the Commission, have become particularly challenging. This
situation not only results in legal uncertainties but also in a reduced
transparency of national pricing and reimbursement measures, which negatively
affects the smooth functioning of the internal market to the detriment of European
patients and pharmaceutical companies.

–
Secondly, the time limits for pricing and
reimbursement decisions established by Directive 89/105/EEC are regularly
exceeded by Member States. This leads to delays in the marketing of medicinal
products, which in turn slows down the availability of valuable treatments for
patients. In 2009, the Commission’s Competition Inquiry into the Pharmaceutical
Sector[5]
recalled that Member States should comply with these time limits. The inquiry also
demonstrated that unnecessary delays in the pricing and reimbursement of
generic medicines delay patients’ access to cheaper medicines and increase the
financial burden on Member States. The Commission therefore considered that pricing
and reimbursement procedures should be shortened with respect to generic
medicinal products. In addition, the sector inquiry showed that the
interference of patent or safety related issues with pricing and reimbursement
processes can significantly delay access to cheaper generic medicinal products.

The fundamental objectives and principles
of Directive 89/105/EEC remain fully valid in the present context. Accordingly,
this initiative aims at adapting the Directive to the current pharmaceutical
environment while preserving its core foundations. The overall objective of the
proposal is to clarify the procedural obligations incumbent upon Member State and
to ensure the effectiveness of the Directive, both in avoiding delays in
pricing and reimbursement decisions and in preventing barriers to
pharmaceutical trade. This shall be done without affecting national social security
policies, except as far as it is necessary to achieve the transparency of national
procedures and the effectiveness of the internal market legislation.

2.           RESULTS OF CONSULTATIONS WITH THE
INTERESTED PARTIES AND IMPACT ASSESSMENT

·
Consultation of interested parties

A public consultation on a possible
revision of Directive 89/105/EEC was held from 28 March to 30 May 2011. In
response to this consultation, the Commission received 102 contributions from a
broad range of stakeholders including national authorities, public health
insurers, individual companies and organisations representing the
research-based pharmaceutical industry, the generic industry, the medical
devices industry and other interested parties such as representatives of the
distribution chain, health professional organisations, patients and citizens.
Small and medium sized enterprises were also consulted through the Enterprise
Europe Network.

A large majority of respondents recognised
the positive impact of the Directive on the transparency of national procedures
and the functioning of the internal market. However, many of them also pointed
to its weak implementation by Member States and highlighted its shortcomings in
terms of legal clarity and enforcement. Opinions differed as to the relevant
actions which should be proposed by the Commission. For instance, the generic
industry unanimously advocated a revision of the Directive, while
research-based companies and their representative organisations favoured a soft
law approach based on an interpretative Communication by the Commission.

The results of the public consultation are
available at: http://ec.europa.eu/enterprise/sectors/healthcare/public-consultation/index_en.htm.
Impact assessment

Responses to the public consultation were
carefully considered during the impact assessment carried out by the Commission
services. The impact assessment report identifies and assesses regulatory and
non-regulatory options to achieve the overall objective of ensuring that adequate
and effective transparency rules apply to the pricing and reimbursement
measures adopted by Member States. The proposal to revise the Directive is
based on the combination of options recommended in the framework of the impact
assessment, namely:

–
To ensure timely pricing and reimbursement
decisions: options A.3/c (regular reports on
pricing and reimbursement approval times), A.4/a (shorter time-limits for
pricing and reimbursement decisions concerning generic medicinal products) and
A.4/b (prohibition of patent linkage and re-assessment of safety features).

–
To ensure the adequacy and effectiveness of
the Directive in the current context: options B.3/b
(extensive revision of the Directive to clarify its scope and wording) and B.4
(notification of draft national measures to facilitate enforcement).

The possible extension of the Directive to
include medical devices was examined in the impact assessment but discarded due
to the specificities of this market.

Furthermore, in spite of the difficulty to
conclude on the overall cost-benefit balance of reducing the time limits with
respect to originator medicines, a reduction from the current 90/180 days to
60/120 days is proposed in light of the positive impact it would have on the
swift availability of innovative medicines to patients and on rewarding
pharmaceutical innovation when medicines are approved for reimbursement. However,
given the complexity of the health technology assessment (HTA) procedures, it
was deemed necessary to find a more differentiated approach for the time limits;
therefore, different time limits are proposed, depending on whether the
medicinal products are subject to health technology assessment (90/180 days) or
not (60/120 days).

The impact assessment report and its executive
summary are available at:          
http://ec.europa.eu/governance/impact/ia_carried_out/cia_2012_en.htm.

3.           LEGAL ELEMENTS OF THE PROPOSAL

·
Legal basis and subsidiarity

The main objective of Directive 89/105/EEC
is to facilitate the functioning of the internal market for medicinal products.
The legal basis is therefore Article 114 of the Treaty on the Functioning of
the European Union.

The existing Directive has as its
underlying principle the idea of minimum interference in the organisation by
Member States of their domestic social security policies.[6] This fundamental principle is
maintained in the proposal. The proposed requirements to ensure timely and
transparent decisions carefully balance the obligation to preserve the
competences of Member States in the field of public health against the
necessity to guarantee the effectiveness of the Directive in meeting its
internal market objectives. In order to respect the responsibilities of the
Member States under the Treaty, the proposal does not provide for the
approximation of national pricing and reimbursement measures, nor does it restrain
the ability of Member States to freely determine the prices of medicines and
the conditions of their public funding on the basis of the criteria they
choose. The impact assessment report explains in further detail how the
subsidiarity and proportionality principles have been taken into account in the
proposal.

·
Overview of the main legal elements

The proposal maintains the core principles
of the existing Directive but also puts forward a comprehensive adaptation of its
legal provisions based on the following key elements:

–
Clarification of the scope of the Directive: the transparency requirements apply to all pricing and
reimbursement measures understood in a broad sense, including “demand side”
measures to control or promote the prescription of specific medicines.
Nevertheless, measures involving public procurement and voluntary contractual
agreements with individual companies are excluded from the scope of the
Directive in order to avoid interference with other bodies of law.

–
Comprehensive coverage of national measures
and legal clarity: the provisions of the Directive are
reworded in accordance with general principles (rather than on the basis of
specific national procedures) and incorporate the case-law of the Court of
Justice. Several key provisions are clarified and updated to avoid interpretation
controversies. In particular, it is made clear that the time limits for pricing
and reimbursement decisions include all procedural steps leading to the
decision, including health technology assessments where applicable.

–
Adaptation of the time limits for pricing and
reimbursement decisions: the time limits applicable
to generic medicines are reduced to 15/30 days when the reference product has
already been priced and included in the health insurance system. The time
limits applicable to all other medicinal products are reduced to 60/120 days. However,
in cases where national authorities subject medicinal products to health
technology assessment procedures in order to assess the relative
efficacy or the short- and long-term effectiveness, as
an integral part of their decision-making process, the time-limits shall be
90/180 days.

–
Non-interference of patent and safety issues
with pricing and reimbursement procedures: the
proposal clarifies that intellectual property rights should not interfere with
pricing and reimbursement procedures, as is already the case for marketing
authorisation procedures. In addition, elements already assessed in the
framework of the marketing authorisation process (quality, safety and efficacy,
including bioequivalence) may not be reassessed in the framework of pricing and
reimbursement procedures.

–
Dialogue and enforcement tools: different instruments are put in place to facilitate dialogue on
the implementation of the Directive and to ensure its effective enforcement (consultation
on draft measures at national level and pre-notification to the Commission, the
creation of a remedies procedure in case of non-compliance with the time-limits
related to the inclusion of medicinal products in health insurance systems).

·
Repeal of Directive 89/105/EEC

The amendments proposed to Directive
89/105/EEC are substantial and cover all major provisions currently in force. For
the sake of legal clarity, and in accordance with the principle of better
regulation, the adoption of the proposal will lead to the repeal of existing
legislation. However, the effects of Article 10 of
Directive 89/105/EEC shall be maintained.

No correlation table is foreseen as the
existing EU legislation referring to Directive 89/105/EEC does so in a general
way without pointing to specific provisions of the Directive.

4.           BUDGETARY IMPLICATION

The Commission's proposal has no impact on
the European Union budget beyond what is already foreseen for the years to come
in the Multiannual Financial Framework. The details of the financial resources
are indicated in the Legislative Financial statement.

5.           TRANSPOSITION

The notification of the Member States'
transposition measures must be accompanied by correlation tables explaining the
relationship between the components of a directive and
the corresponding parts of national transposition instruments. This is
necessary due to:

·
The complexity of the Directive, which does not
touch upon the substance but only lays down minimum procedural requirements to
ensure the transparency of the measures regulating the
prices of medicinal products for human use and their inclusion in the scope of
public health insurance systems.

·
The complexity of the transposition process due
to the difficulties related to the interpretation of the Directive. The application
of a set of procedural rules to the complicated architecture of the pricing and
reimbursement systems is not always easy and straightforward.

·
The constant evolution of national measures on
pricing and reimbursement in view of controlling pharmaceutical expenditure,
which makes it difficult to monitor the implementation process.

Therefore, the obligation to communicate
correlation tables will facilitate the implementation process.

6.           ADDITIONAL INFORMATION

The proposed act concerns an EEA matter and
should therefore extend to the European Economic Area.

2012/0035 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

relating to the transparency of measures
regulating the prices of medicinal products for human use and their inclusion
in the scope of public health insurance systems

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[7],

Acting in accordance with the ordinary legislative
procedure,

Whereas:

(1)
Council Directive 89/105/EEC of 21 December 1988
relating to the transparency of measures regulating the pricing of medicinal
products for human use and their inclusion in the scope of national health
insurance systems[8]
was adopted so as to remove distortions to intra-Community trade in medicinal
products.

(2)
In order to take into account the evolution of
the pharmaceutical market and of national policies to control public
expenditure on medicines, substantive changes are necessary to all major provisions
of Directive 89/105/EEC. Therefore, in the interest of clarity, Directive 89/105/EEC
should be replaced.

(3)
Union legislation provides a harmonised
framework for the authorisation of medicinal products for human use. According
to Directive 2001/83/EC of the
European Parliament and of the Council of 6 November 2001 on the Community code
relating to medicinal products for human use,[9] medicinal
products may be placed on the market in the Union only after they have received
a marketing authorisation based on the evaluation of their quality, safety and
efficacy.

(4)
Member States have been confronted to a steady
rise in pharmaceutical expenditure over the last decades, leading to the
adoption of increasingly innovative and complex policies to manage the
consumption of medicines in the framework of their public health insurance
systems. In particular, Member States’ authorities have implemented a broad range
of measures to control the prescription of medicines, to regulate their prices
or to establish the conditions of their public funding. Such measures mainly aim
at promoting public health by
ensuring the availability of adequate supplies of medicinal products at
reasonable costs, while ensuring the financial stability of public health
insurance systems.

(5)
Disparities in national measures may hinder or
distort intra-Union trade in medicinal products and distort competition, thereby
directly affecting the functioning of the internal market in medicinal products.

(6)
In order to reduce the effects of the
disparities on the internal market, national measures should comply with
minimum procedural requirements enabling the parties concerned to verify that
those measures do not constitute quantitative restrictions
on imports or exports or measures having equivalent effect thereto. However, those requirements should not affect the
policies of those Member States which rely primarily upon free competition to
determine the price of medicinal products. They also should not affect national
policies on price setting and on the determination of social security schemes,
except as far as it is necessary to attain transparency within the meaning of
this Directive and to ensure the functioning of the internal market.

(7)
In order to ensure the effectiveness of the
internal market in medicinal products, this Directive should apply to all
medicinal products for human use within the meaning of Directive 2001/83/EC.

(8)
Due to diversity of national measures managing
the consumption of medicines, regulating their prices or establishing the
conditions of their public funding it is necessary to clarify Directive
89/105/EEC. In particular this Directive should cover all types of measures
devised by Member States and susceptible to impact the internal market. Since
the adoption of Directive 89/105/EEC, the pricing and reimbursement procedures
have evolved and have become more complex. While some Member States have
interpreted the scope of Directive 89/105/EEC restrictively, the Court of
Justice ruled that those pricing and reimbursement procedures fall within the
scope of Directive 89/105/EEC given the objectives of that Directive and the
need to ensure its effectiveness. Therefore, this Directive should reflect the
developments in national pricing and reimbursement policies. Given that specific rules and procedures exist in the area of public procurement
and voluntary contractual agreements, national measures involving public
procurement and voluntary contractual agreements should be excluded from the
scope of this Directive.

(9)
Any measure to regulate, either directly or
indirectly, the prices of medicinal products, as well as any measure to
determine their coverage by public health insurance systems should be based on
objective and verifiable criteria that are independent from the origin of the
product and should provide adequate legal remedies, including judicial remedies,
to affected companies. These requirements should equally apply to national, regional
or local measures to control or promote the prescription of specific medicinal
products as such measures also determine their effective coverage by health
insurance systems.

(10)
Applications to approve the price of a medicinal
product or to determine its coverage by the health insurance system should not
delay the placing on the market of that product beyond what is necessary. It is
therefore desirable that this Directive sets out mandatory time limits within
which national decisions should be made. In order to be effective, the
prescribed time periods should run from the receipt of an application until the
entry into force of the corresponding decision. They should include all expert evaluations,
including health technology assessments where applicable, and all administrative
steps required for the decision to be adopted and take legal effect.

(11)
The time-limits for the inclusion of medicinal
products in the health insurance systems set out in Directive 89/105/EEC are
mandatory as clarified by the case-law of the Court of Justice. Experience has
shown that those time limits are not always respected and that there is need to
ensure legal certainty and improve the procedural rules related to the
inclusion of medicinal products in the scope of health insurance system.
Therefore, an effective and rapid remedies procedure should be put in place.

(12)
In its Communication "Executive Summary of
the Pharmaceutical Sector Inquiry Report"[10]
the Commission demonstrated that pricing and reimbursement procedures often
unnecessarily delay the launch of generic medicines in Union markets. Approving
the price of generic medicinal products and their coverage by the health
insurance system should not require any new or detailed assessment when the
reference product has already been priced and included in the health insurance
system. It is therefore appropriate to lay down shorter time limits for generic
medicinal products in those cases.

(13)
The judicial remedies available in the Member
States have played a limited role in ensuring compliance with the time limits due
to the often lengthy procedures in national jurisdictions, which deter affected
companies from initiating legal action. Therefore, effective mechanisms are
necessary to control and enforce compliance with the time limits for pricing
and reimbursement decisions.

(14)
The quality, safety and efficacy of medicinal
products, including the bioequivalence of generic medicinal products with the
reference product, are ascertained in the framework of marketing authorisation
procedures. In the framework of pricing and reimbursement procedures, Member
States should therefore not re-assess the elements on which the marketing
authorisation is based, including the quality, safety, efficacy or
bioequivalence of the medicinal product.

(15)
In accordance with Directive 2001/83/EC, intellectual
property rights do not provide a valid ground to refuse, suspend or revoke a
marketing authorisation. By the same token, applications, decision-making
procedures and decisions to regulate the prices of medicinal products or to determine
their coverage by health insurance systems should be considered administrative
procedures which, as such, are independent from the enforcement of intellectual
property rights. The national authorities in charge of those procedures, when
examining an application with respect to a generic medicinal product, should
not request information concerning the patent status of the reference medicinal
product and should not examine the validity of an alleged violation of intellectual
property rights should the generic medicinal product be manufactured or placed
on the market subsequently to their decision. Consequently, intellectual
property issues should neither interfere with nor delay pricing and
reimbursement procedures in the Member States.

(16)
Member States have frequently amended their
health insurance schemes or adopted new measures falling within the scope of
Directive 89/105/EEC. It is therefore necessary to establish information
mechanisms intended, on the one hand, to ensure the consultation of interested
stakeholders and, on the other hand, to facilitate preventive dialogue with the
Commission as regards the application of this Directive.

(17)
Since the objective of the action to be taken, namely
providing minimal transparency rules to ensure the functioning of the internal
market, cannot be sufficiently achieved by the Member States, as the notion of
transparency of national measures is understood and applied differently in each
Member State, and can therefore, by reason of the scale of the action be better
achieved at Union level, the Union may adopt measures, in accordance with the
principle of subsidiarity as set out in Article 5 of the Treaty on European
Union. In accordance with the principle of proportionality, as set out in that
Article, this Directive does not go beyond what is necessary in order to
achieve that objective.

(18)
In accordance with the Joint Political
Declaration of Member States and the Commission on explanatory documents of 28
September 2011, Member States have undertaken to accompany, in justified cases,
the notification of their transposition measures with one or more documents
explaining the relationship between the components of a directive and the
corresponding parts of national transposition instruments. With regard to this
Directive, the legislator considers the transmission of such documents to be
justified.

HAVE ADOPTED THIS DIRECTIVE:

Chapter I

Scope and definitions

Article 1

Subject matter and scope

1.
Member States shall ensure that any national,
regional or local measure, whether laid down by law, regulation or
administrative action, to control the prices of medicinal products for human
use or to determine the range of medicinal products covered by public health
insurance systems, including the extent and conditions of their coverage,
complies with the requirements of this Directive.

2.
This Directive shall not
apply to the following:

(a)
voluntary contractual agreements concluded between
public authorities and the holder of a marketing authorisation for a medicinal
product that have as their object to enable the effective provision of this
medicine to patients under specific conditions;

(b)
national measures intended to determine the
prices or the coverage of medicinal products by public health insurance systems
which are subject to national or Union legislation on public procurement, in
particular Council Directive 89/665/EEC,[11]
Council Directive 92/13/EEC[12]
and Directive 2004/18/EC of the European Parliament and of the Council.[13]

The provisions of this Directive shall apply to
measures intended to determine which medicinal products may be included in
contractual agreements or public procurement procedures.

3.
Nothing in this Directive shall permit the
placing on the market of a medicinal product which has not received marketing
authorisation as provided for in Article 6 of Directive 2001/83/EC.

Article 2

Definitions

For the purposes of this Directive, the
following definitions apply:

(1)
“medicinal product” means a medicinal product as
defined in Article 1 of Directive 2001/83/EC;

(2)
“reference medicinal product” means a reference
medicinal product as defined in point (a) of Article 10(2) of Directive
2001/83/EC;

(3)
“generic medicinal product” means a generic medicinal
product as defined in point (b) of Article 10(2) of Directive 2001/83/EC .

(4)
“health technology” means a health technology as
defined in point (l) of Article 3 of Directive 2011/24/EU of the European
Parliament and of the Council;[14]

(5)
“health technology assessment” means an assessment
of the relative efficacy or of the short- and long-term
effectiveness of the medicinal product compared to
other health technologies in use for treating the associated condition.

Chapter II

Pricing of medicinal products

Article 3

Price approval

1.
Paragraphs 2 to 9 shall apply if the marketing of a
medicinal product is permitted only after the competent authorities of the
Member State concerned have approved the price of the product.

2.
Member States shall ensure that an application
to approve the price of the product can be introduced by the marketing
authorisation holder at any point in time. The competent authorities shall
provide the applicant with an official acknowledgement of receipt.

3.
Member States shall ensure that a decision on the
price which may be charged for the medicinal product concerned is adopted and
communicated to the applicant within 60 days of the receipt of an application
submitted, in accordance with the requirements laid down in the Member State
concerned, by the holder of a marketing authorisation. However, with respect to
medicinal products for which Member States use health technology assessment as
part of their decision-making process, the time-limit shall be 90 days. With
respect to generic medicinal products, that time limit shall be 15 days, provided
that the price of the reference medicinal product has been approved by the
competent authorities.

4.
Member States shall establish in detail the
particulars and documents to be submitted by the applicant.

5.
If the information supporting the application is
inadequate, the competent authorities shall forthwith notify the applicant of the
detailed additional information required and take their final decision within 60
days of receipt of this additional information. However, with respect to
medicines for which Member States use health technology assessment as part of
their decision-making process, the time-limit shall be 90 days. With respect to
generic medicinal products, that time limit shall be in all events 15 days, provided
that the price of the reference medicinal product has been approved by the
competent authorities. Member States shall not request any additional
information which is not explicitly required under national legislation or
administrative guidelines.

6.
In the absence of a decision within the relevant
time limit set out in paragraphs 3 and 5, the applicant shall be entitled to
market the product at the price proposed.

7.
If the competent authorities decide not to permit
the marketing of the medicinal product concerned at the price proposed by the
applicant, the decision shall contain a statement of reasons based on objective
and verifiable criteria, including any evaluation, expert opinion or
recommendation on which it is based. The applicant shall be informed of all remedies
available, including judicial remedies, and of the time limits for applying for
such remedies.

8.
Member States shall publish in an appropriate
publication and communicate to the Commission the criteria which the competent
authorities must take into account when approving the prices of medicinal
products.

9.
If the competent authorities decide to reduce
the price of a specific named medicinal product on their own initiative, the
decision shall contain a statement of reasons based on objective and verifiable
criteria, including any evaluation, expert opinion or recommendation on which
it is based. The decision shall be communicated to the holder of the marketing
authorisation, who shall be informed of all remedies available, including
judicial remedies, and of the time limits for applying for such remedies.

Article 4

Price increase

1.
Without prejudice to Article 5, paragraphs (2) to (6)
shall apply if an increase in the price of a medicinal product is permitted
only after prior approval has been obtained from the competent authorities.

2.
Member States shall ensure that an application to
increase the price of the product can be submitted by the marketing
authorisation holder at any point in time. The competent authorities shall
provide the applicant with an official acknowledgement of receipt.

3.
Member States shall ensure that a decision on an
application submitted in accordance with the requirements laid down in the
Member State concerned, by a marketing authorisation holder to increase the
price of a medicinal product is adopted and communicated to the applicant
within 60 days of its receipt.

In case of an exceptional number of applications,
the time limit set out in this paragraph may be extended once only for a
further 60 days. The applicant shall be notified of such an extension before
the expiry of the time limit set out in this paragraph.

4.
Member States shall establish in detail the
particulars and documents to be submitted by the applicant.

The applicant shall furnish the competent
authorities with adequate information, including details of those events
intervening since the price of the medicinal product was last determined which
in his opinion justify the price increase requested. If
the information supporting the application is inadequate, the competent
authorities shall forthwith notify the applicant of the detailed additional
information required and take their final decision within 60 days of receipt of
this additional information. Member States shall not request any additional
information which is not explicitly required under national legislation or
administrative guidelines.

5.
In the absence of a decision within the relevant
time limit referred to in paragraphs 3 and 4, the applicant shall be entitled
to apply the price increase requested.

6.
If the competent authorities decide not to permit
the whole or part of the price increase requested, the decision shall contain a
statement of reasons based on objective and verifiable criteria and the
applicant shall be informed of all remedies available, including judicial
remedies, and of the time limits for applying for such remedies.

Article 5

Price
freeze and price reduction

1.
In the event of a price freeze or price reduction imposed
on all medicinal products or on certain categories of medicinal products by the
competent authorities of a Member State, that Member State shall publish a
statement of reasons for its decision based on objective and verifiable
criteria, including, if applicable, a justification of the categories of
products subject to the price freeze or price reduction.

2.
Marketing authorisation holders may apply for a
derogation from a price freeze or price reduction if this is justified by
particular reasons. The application shall contain an adequate statement of
reasons. Member States shall ensure that applications for a derogation can be
introduced by the marketing authorisation holder at any point in time. The
competent authorities shall provide the applicant with an official
acknowledgement of receipt.

3.
Member States shall ensure that a reasoned decision
on an application referred to in paragraph 2 is adopted and communicated to the
applicant within 60 days of the receipt of the application. If the information
supporting the application is inadequate, the competent authorities shall
forthwith notify the applicant of the detailed additional information required
and take their final decision within 60 days of receipt of this additional
information. If the derogation is granted, the competent authorities shall
forthwith publish an announcement of the price increase allowed.

If there is an exceptional number of applications,
the relevant time limit set out in paragraph 3 may be extended once only for a
further 60 days. The applicant shall be notified of such extension before the
expiry of the time limit set out in paragraph 3

Article 6

Controls
on profits

Where a Member State adopts a system of
direct or indirect controls on the profitability of persons responsible for
placing medicinal products on the market, the Member State concerned shall
publish the following information in an appropriate publication and communicate
it to the Commission:

(a)
the method or methods used in the Member State
concerned to define profitability: return on sales and/or return on capital;

(b)
the range of target profit currently permitted to
persons responsible for placing medicinal products on the market in the Member
State concerned;

(c)
the criteria according to which target rates of
profit are accorded to an individual responsible for placing medicinal products
on the market, together with the criteria according to which they will be
allowed to retain profits above their targets in the Member State concerned;

(d)
the maximum percentage profit which any person
responsible for placing medicinal products on the market is allowed to retain
above his target in the Member State concerned.

The information referred to in the first
subparagraph shall be updated once a year or when significant changes are made.

Where, in addition to operating a system of
direct or indirect controls on profits, a Member State operates a system of
controls on the prices of certain types of medicinal products which are
excluded from the scope of the profit control scheme, Articles 3, 4 and 5
shall, where relevant, apply to such price controls. However, those Articles
shall not apply where the normal operation of a system of direct or indirect
controls on profits results exceptionally in a price being fixed for an
individual medicinal product.

Chapter III

Coverage of medicinal products by public
health insurance systems

Article 7

Inclusion of medicinal products in health
insurance systems

1.
Paragraphs 2 to 9 shall apply if a medicinal
product is covered by the public health insurance system only after the
competent authorities have decided to include the medicinal product concerned in
the scope of that system.

2.
Member States shall ensure that an application
to include a medicinal product in the scope of the public health insurance
system can be introduced by the marketing authorisation holder at any point in
time. If the public health insurance system comprises several schemes or
categories of coverage, the marketing authorisation holder shall be entitled to
apply for the inclusion of its product in the scheme or category of its choice.
The competent authorities shall provide the applicant with an official
acknowledgement of receipt.

3.
Member States shall establish in detail the
particulars and documents to be submitted by the applicant.

4.
Member States shall ensure that a decision on an
application to include a medicinal product in the scope of the public health
insurance system, submitted by the marketing authorisation holder in accordance
with the requirements laid down in the Member State concerned, is adopted and
communicated to the applicant within 60 days of its receipt. However, with respect to medicinal products for which Member States use
health technology assessment as part of their decision-making process, the
time-limit shall be 90 days. With respect to generic
medicinal products, that time limit shall be 15 days, provided
that the reference medicinal product has already been included in the public
health insurance system.

5.
If the information supporting the application is inadequate,
the competent authorities shall forthwith notify the applicant of the detailed
additional information required and take their final decision within 60 days of
receipt of this additional information. However, with respect to medicinal
products for which Member States use health technology assessment as part of
their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be
15 days, provided that the reference medicinal product has
already been included in the public health insurance system. Member States
shall not request any additional information which is not explicitly required
under national legislation or administrative guidelines.

6.
Irrespective of the organisation of their internal procedures,
Member States shall ensure that the overall period of time taken by the
inclusion procedure set out in paragraph 5 of this Article and the price
approval procedure set out in Article 3 does not exceed 120 days. However, with
respect to the medicinal products for which Member States use health technology
assessment as part of their decision-making process, the time limit shall not
exceed 180 days. With respect to generic medicinal
products, that time limit shall not exceed 30 days, provided that the reference medicinal product has already been included in the public
health insurance system. Those time-limits may be extended in accordance with paragraph
5 of this Article or Article 3(5).

7.
Any decision not to include a medicinal product within
the scope of the public health insurance system shall contain a statement of
reasons based upon objective and verifiable criteria. Any decision to include a
medicinal product within the scope of the public health insurance system shall
contain a statement of reasons justifying the decision, including the extent
and conditions of the product’s coverage, on the basis of objective and
verifiable criteria.

The decisions referred to in this paragraph shall also
include any evaluation, expert opinion or recommendation on which they are
based. The applicant shall be informed of all remedies available, including
judicial remedies, and the remedies procedure set out Article 8, of the time
limits for applying for such remedies.

8.
Member States shall publish in an appropriate publication
and communicate to the Commission the criteria which the competent authorities must
take into account when deciding whether or not to include medicinal products within
the scope of the public health insurance system.

Article 8

Remedies procedure in case of non-compliance with the time limits
related to the inclusion of medicinal products in health insurance systems

1.
Member States shall ensure that effective and
rapid remedies are available to the applicant in case of non-compliance with
the time limits set in Article 7.

2.
For the purposes of the remedies procedure
Member States shall designate a body and entrust it with the powers to:

(a)
take, at the earliest opportunity and by way of
interlocutory procedures, interim measures with the aim of correcting the
alleged infringement or preventing further damage to the interests concerned;

(b)
award damages to the applicant in case of
non-compliance with time limits set in Article 7 where damages are claimed,
unless the competent authority may prove that the delay is not imputable to it;

(c)
impose a penalty payment, calculated by day of
delay.

For the purposes of point (c), the penalty payment shall be calculated depending on the seriousness of the infringement, its duration, the need to ensure
that the penalty itself is a deterrent to further infringements.

Member States may provide
that the body referred to in the first subparagraph may take into account the
probable consequences of potential measures taken under the present paragraph
for all interests likely to be harmed, as well as the public interest, and may
decide not to take such measures when their negative consequences could exceed
their benefits.

3.
A decision not to grant interim measure shall not
prejudice any other claim of the applicant seeking such measures.

4.
Member States shall ensure that decisions taken by
bodies responsible for remedies procedures can be effectively enforced.

5.
The body referred to in paragraph 2 shall be
independent of the competent authorities in charge of controlling the prices of
medicinal products for human use or in charge of determining the range of
medicinal products covered by health insurance systems.

6.
The body referred to in
paragraph 2 shall state reasons for its decision. Furthermore, where that body is not judicial in character, provision
must be made to guarantee procedures whereby any allegedly illegal measure
taken by the independent body or any alleged defect in the exercise of powers
conferred on it can be subject to judicial review or review by another body
which is a court or tribunal within the meaning of Article 267 of the Treaty on
the Functioning of the European Union and independent of both the competent
authority and the body referred to in paragraph 2.

The members of the body
referred to in paragraph 2 shall be appointed and leave office under the same
conditions as members of the judiciary as regards the authority responsible for
their appointment, their period of office, and their removal. At least the
president of that body shall have the same legal and professional
qualifications as members of the judiciary. That body shall take its decisions
following a procedure in which both sides are heard, and these decisions shall,
by means determined by each Member State, be legally binding.

Article 9

Exclusion of medicinal products from health
insurance systems

1.
Any decision to exclude a medicinal product from
the scope of the public health insurance system, or to modify the extent or the
conditions of coverage of the product concerned, shall contain a statement of
reasons based on objective and verifiable criteria. Such decisions shall
include any evaluation, expert opinion or recommendation on which they are
based. The applicant shall be informed of all remedies available, including
judicial remedies, and of the time limits for applying for such remedies.

2.
Any decision to exclude a category of medicinal
products from the scope of the public health insurance system, or to modify the
extent or the conditions of coverage of the category concerned, shall contain a
statement of reasons based on objective and verifiable criteria and be
published in an appropriate publication.

Article 10

Classification of medicinal products in
view of their inclusion in health insurance systems

1.
Paragraphs 2, 3 and 4 shall apply where
medicinal products are grouped or classified according to therapeutic or other
criteria for the purpose of their inclusion within the scope of the public
health insurance system.

2.
Member States shall publish in an appropriate
publication and communicate to the Commission the objective and verifiable criteria
according to which medicinal products are classified in view of their inclusion
in the public health insurance system.

3.
For the medicinal products subject to such
grouping or classification, Member States shall publish in an appropriate
publication and communicate to the Commission the methodologies used to
determine the extent or conditions of their inclusion in the public health
insurance system.

4.
At the request of the holder of a marketing
authorisation, the competent authorities shall specify the objective data on
the basis of which they have determined the arrangements of coverage for their
medicinal product, in application of the criteria and methodologies referred to
in paragraphs 2 and 3. In such a case, the competent authorities shall also
inform the marketing authorisation holder of all remedies available, including
judicial remedies, and of the time limits for applying for
such remedies.

Article 11

Measures to control or promote the
prescription of specific medicinal products

1.
Paragraphs 2, 3 and 4 shall apply where a Member
State adopts measures intended to control or promote the prescription of specific
named medicinal products.

2.
Measures referred to in paragraph 1 shall be
based on objective and verifiable criteria.

3.
Measures referred to in paragraph 1, including
any evaluation, expert opinion or recommendation on which they are based, shall
be published in an appropriate publication.

4.
At the request of the holder of a marketing
authorisation whose interests or legal position are affected by the measures
referred to in paragraph 1, the competent authorities shall specify the
objective data and criteria on the basis of which these measures have been
taken with respect to its medicinal product. In such a case, the competent
authorities shall also inform the marketing authorisation holder of all
remedies available, including judicial, and of the time limits for applying for
such remedies.

Chapter IV

Specific requirements

Article 12

Effectiveness of the time limits

The time limits laid down in Articles 3, 4, 5
and 7 shall be construed as the period between the receipt
of an application or additional information, as the case may be, and the effective
entry into force of the corresponding decision. All expert
evaluations and administrative steps necessary for taking the decision and
bringing it into effect shall be carried out within the prescribed time limits.

Article 13

Additional
proof of quality, safety, efficacy or bioequivalence

In the framework of pricing and reimbursement
decisions, Member States shall not re-assess the elements on which the
marketing authorisation is based, including the quality, safety, efficacy or
bioequivalence of the medicinal product.

Article 14

Non interference of intellectual property rights

1.
Applications, decision-making procedures and
decisions to regulate the prices of medicinal products in accordance with
Article 3 or to determine their inclusion within the scope of public health
insurance systems in accordance with Articles 7 and 9 shall be considered by
Member States as administrative procedures which, as such, are independent from
the enforcement of intellectual property rights.

2.
The protection of intellectual property rights
shall not be a valid ground to refuse, suspend or revoke decisions relating to
the price of a medicinal product or its inclusion within the public health
insurance system.

3.
Paragraphs 1 and 2 shall apply without prejudice
to the Union and national legislation relating to the protection of intellectual
property.

Chapter V

Transparency mechanisms

Article 15

Consultation of interested parties

Where a Member State intends to adopt or amend
any measure falling within the scope of this Directive, it shall give
interested parties the opportunity to comment on the draft measure within a
reasonable period. The competent authorities shall publish the rules applicable
to consultations. The results of consultations shall be made publicly
available, with the exception of confidential information in accordance with
Union and national legislation regarding business confidentiality.

Article 16

Notification of draft national measures

1.
Where Member States intend to adopt or amend any
measure falling within the scope of this Directive, they shall immediately
communicate to the Commission the draft measure envisaged, together with the
reasoning on which the measure is based.

2.
Where appropriate, Member States shall
simultaneously communicate the texts of the basic
legislative or regulatory provisions principally and directly concerned, if knowledge
of such texts is necessary to assess the implications of the measure proposed.

3.
Member States shall communicate the draft measure
referred to in paragraph 1 again if they make changes to the draft that have
the effect of significantly altering its scope or substance, or shortening the
timetable originally envisaged for implementation.

4.
The Commission may send its observations to the
Member State which has communicated the draft measure within three months.

The observations of the Commission shall be taken
into account as far as possible by the Member State concerned, in particular if
the observations indicate that the draft measure may be incompatible with Union
law.

5.
When the Member State concerned definitively adopts
the draft measure, it shall communicate the final text to the Commission
without delay. If observations have been made by the Commission in accordance
with paragraph 4, this communication shall be accompanied by a report on the
actions taken in response to the observations of the Commission.

Article 17

Report on the implementation of the time limits

1.
By 31 January of [...] [insert a date - the
year following the date referred to in the first subparagraph of Article 18(1)],
and by 31 January and 1 July of every year thereafter, Member States shall
communicate to the Commission and publish in an appropriate publication a
detailed report providing the following information:

(a)
the number of applications received in accordance
with Articles 3, 4 and 7 during the preceding year;

(b)
the amount of time taken to issue a decision on
each of the applications received in accordance with Articles 3, 4, and 7.

(c)
an analysis of the main reasons for delays, if any,
together with recommendations to bring decision-making processes into line with
the time limits laid down in this Directive.

For the purposes of point (a) of the first
subparagraph, a distinction shall be made between generic medicinal products
subject to shorter time limits in accordance with Articles 3, 4 and 7 and other
medicinal products.

For the purposes of point (b) of the first
subparagraph, any suspension of the procedure to request additional information
to the applicant shall be reported with a clear indication of the duration of
the suspension and the detailed reasons for the suspension.

2.
The Commission shall publish every six months a report
on the information submitted by Member States according to paragraph 1.

Chapter VI

Final provisions

Article 18

Transposition

1.
Member States shall adopt and publish, by [last
day of the 12th month following publication of this Directive in the
Official journal of the European Union] at the latest, the laws,
regulations and administrative provisions necessary to comply with this
Directive. They shall forthwith communicate to the
Commission the text of those provisions.

They shall apply those
provisions from [the day after the date set out in the first subparagraph.].

When Member States adopt those provisions, they
shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

2.
Member States shall communicate to the
Commission the text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 19

Report on the implementation of this
Directive

1.
Member States shall send a report to the
Commission on the implementation of this Directive by [insert date - within
two years after the date referred to in the second subparagraph of Article 18(1)]
and every three years thereafter.

2.
By [insert date - within three years after
the date referred to in the second subparagraph of Article 18(1)], the
Commission shall submit a report to the European Parliament and the Council on
the implementation of this Directive. The report may be accompanied by any
appropriate proposals.

Article 20

Repeal

Directive 89/105/EEC is repealed from [the
date set out in the second subparagraph of Article 18(1)].

The effects of Article 10 of Directive 89/105/EEC shall be maintained.

References to the repealed Directive shall be construed
as references to this Directive.

Article 21

Entry into force and application

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal of
the European Union.

Article 16 shall apply from [insert the date - date set out in the second subparagraph of Article 18(1)].

Article 22

Addressees

This
Directive is addressed to the Member States.

Done at Brussels, 1.3.2012

For the European Parliament                       For
the Council

The President                                                 The
President

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.    Title of the proposal/initiative

1.2.    Policy
area(s) concerned in the ABM/ABB structure

1.3.    Nature
of the proposal/initiative

1.4.    Objective(s)

1.5.    Grounds
for the proposal/initiative

1.6.    Duration
and financial impact

1.7.    Management
method(s) envisaged

2.           MANAGEMENT MEASURES

2.1.    Monitoring
and reporting rules

2.2.    Management
and control system

2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

3.2.    Estimated
impact on expenditure

3.2.1. Summary of
estimated impact on expenditure

3.2.2. Estimated impact
on operational appropriations

3.2.3. Estimated impact
on appropriations of an administrative nature

3.2.4. Compatibility
with the current multiannual financial framework

3.2.5. Third-party
participation in financing

3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

1.
FRAMEWORK OF THE PROPOSAL/INITIATIVE
1.1.
Title of the proposal/initiative

Proposal for a Directive of the European Parliament and of the
Council relating to the transparency of measures regulating the prices of
medicinal products for human use and their inclusion in the scope of public
health insurance systems (Repealing Directive 89/105/EEC)

1.2.
Policy area(s) concerned in the ABM/ABB
structure[15]

Title 02 – Enterprise

1.3.
Nature of the proposal/initiative

ý The proposal/initiative relates to the
extension of an existing action

1.4.
Objectives
1.4.1.
The Commission's multiannual strategic
objective(s) targeted by the proposal/initiative

1a. Competitiveness for growth and employment

1.4.2.
Specific objective(s) and ABM/ABB activity(ies)
concerned

Specific objective No.1.

To continually develop existing internal market acquis and
propose new legislative or non-legislative action whenever appropriate

ABM/ABB activity(ies) concerned

Chapter 02 03: Internal market for goods and sectoral policies

1.4.3.
Expected result(s) and impact

Specify the
effects which the proposal/initiative should have on the beneficiaries/groups
targeted.

The proposal provides for a comprehensive update of
Directive 89/105/EEC in view of ensuring the transparency of national measures
regulating the prices of medicinal products for human use and their inclusion
in the scope of social security systems. The existing directive has become
outdated and difficult to enforce due to the evolution of the pharmaceutical
market in the last twenty years and to the multiplication of national measures
to contain growing pharmaceutical costs. The proposal aims at avoiding barriers
to the free movement of goods prohibited by the EU Treaty, while respecting the
responsibilities of the Member States for the organisation of their health
insurance systems. The initiative is expected to:

- Improve legal clarity and certainty for all interested
parties;

- Provide a level playing field for pharmaceutical
companies operating in Europe;

- Facilitate the enforcement of the procedural
obligations incumbent upon Member States.

1.4.4.
Indicators of results and impact

Specify the indicators for monitoring implementation
of the proposal/initiative.

The proposal consists in a directive to be transposed into national
legislation by the Member States. The first indicator will therefore be the
actual transposition rate by the end of the transposition deadline. Budget is
earmarked in order to ensure the verification of transposition by Member
States.

Effective implementation will be monitored as a second step. The key
objectives pursued by the proposal consist in a) guaranteeing that national
pricing and reimbursement decisions are made within specific time-limits and b)
ensuring the effectiveness of minimal transparency rules for national pricing
and reimbursement measures. Results will be measured against the following
indicators:

1/ Actual timing for pricing and reimbursement decisions in the
Member States (monitoring instrument: mandatory annual reporting by Member
States).

2/ Number of non-compliance cases identified in the Member States
(monitoring instruments: mandatory notification of draft national measures by
national authorities and statistics of infringement procedures).

1.5.
Grounds for the proposal/initiative
1.5.1.
Requirement(s) to be met in the short or long
term

The text of the proposal essentially requires Member States to
ensure that:

1/ Pricing and reimbursement decisions are made within 60/120 days. However, with respect to medicines for which Member States use health
technology assessment as part of their decision-making process, the time-limit
shall be 90/180 days. Furthermore, the timeframe is
reduced to 15/30 days with respect to generic medicinal products.

2/ Any measure intended to regulate the prices of medicines, to
manage their consumption or to determine their reimbursement status is adopted
in a transparent manner on the basis of objective and verifiable criteria.

3/ Effective judicial
remedies are available to affected pharmaceutical companies.

1.5.2.
Added value of EU involvement

National pricing and reimbursement measures have a clear
transnational impact linked, in particular, to the potential disruption they
might cause to the internal market for medicinal products. The proper
functioning of the internal market therefore requires timely and transparent
decisions to be made by Member States. The notion of procedural transparency is
understood differently across the EU so that action by individual Member States
would not provide sufficient guarantees of transparency for economic operators.

1.5.3.
Lessons learned from similar experiences in the
past

In the last twenty years, Directive 89/105/EEC has played a key role
in promoting the transparency of national pricing and reimbursement measures.
However, experience in managing the directive has shown that:

1/ National pricing and reimbursement policies evolve at a quick
pace, so that the requirements of the directive should be based on general
principles rather than on the description of specific types of measures.

2/ The effective
monitoring of national legislation in this field of competence belonging
essentially to the Member States requires stronger information and enforcement
mechanisms.

1.5.4.
Coherence and possible synergy with other
relevant instruments

The proposal must be seen in the context of the Commission’s efforts
to reinforce the internal market and to generate favourable conditions for a
competitive pharmaceutical industry that provides safe, innovative and
accessible medicines to European citizens. It relates to a number of recent or
on-going initiatives, in particular:

1/ The Commission Communication on a renewed vision for the
pharmaceutical sector (2008), which announced that the application of Directive
89/105/EEC would be enhanced to ensure genuinely transparent and speedy pricing
and reimbursement decisions.

2/ The Commission’s
Pharmaceutical Sector Inquiry (2008-2009), which concluded that the Commission
might examine the potential need to review Directive 89/105/EEC in order to
facilitate timely market access for generic medicines.

3/ The political
initiatives to foster cooperation between Member States on pricing and
reimbursement challenges, in particular the High Level Pharmaceutical Forum
(2005-2008) and the Process on Corporate Responsibility in the Field of
Pharmaceuticals launched by the European Commission in 2010.

4/ Voluntary
cooperation between Member States on health technology assessments currently
take forward in the framework of the EUNetHTA Joint Action and to be formalised
through the implementation of Directive 2011/24/EU on the application of
patients’ rights in cross-border healthcare.

1.6.
Duration and financial impact

ý Proposal/initiative of unlimited
duration

–
Depending on progress with the legislative
process, implementation is envisaged to begin in 2014 (adoption by Council and
Parliament) with a deadline for transposition by Member States in 2015.

1.7.
Management mode(s) envisaged[16]

ý Centralised direct management by the Commission

Comments

Member
States will be responsible for implementing the provisions of the directive.
The Commission’s role will mainly consist in:

-Facilitating and verifying the transposition of
the Directive. Budget impact: administrative expenditure (missions,
conferences, etc.) and expert support (verification of transposition).

- Facilitating the implementation of the
Directive in the context of the Committee created according to Article 10 of Directive 89/105/EEC and composed
of national representatives and chaired by the Commission services. Budget
impact: administrative expenditure for the organisation of the Committee.

- Checking the compliance with the provisions of
the Directive of draft national measures notified to the Commission. Budget
impact: this activity involves the mobilisation of additional human resources,
external translation work as well as the development of specific IT tools for
communication with Member States.

- The financial resources required will be met by
the existing resources (internal market line) which are already assigned to the
management of the actions and/or by redeployment within the DG.

2.
MANAGEMENT MEASURES
2.1.
Monitoring and reporting rules

The proposal requires Member States to communicate to the
Commission:

1/ The criteria they use to approve the prices
of medicines and to decide whether or not to include medicinal products within
the scope of the public health insurance system. Any amendment to these
criteria should be reported as well.

2/ Specific information on the effective timing for their pricing
and reimbursement decisions (frequency: every six months)

3/ Any draft proposal falling within the scope of the Directive
(permanent verification of compliance and early dialogue).

4/ A report on the implementation of the Directive within two years
following transposition.

The information communicated will be assessed by the Commission and,
if necessary, discussed with the Member States for appropriate follow-up.

2.2.
Management and control system
2.2.1.
Risk(s) identified

The main risks in managing the proposed legislation relate to the
following three phases:

- Initial transposition in national laws;

- Compliance of any new national measure falling within
the scope of the Directive;

- Effective
implementation of the procedural requirements laid down in national law.

2.2.2.
Control method(s) envisaged

The control methods envisaged are described in detail in the
Transposition and Implementation Plan (TIP). They mainly consist in:

- The provision of technical expertise by the Commission
during the transposition phase;

- The adoption of interpretative guidelines by the
Commission, in cooperation with the Member States, to clarify implementation
issues, if any;

- The verification of compliance of draft national
measures by the Commission;

- The review of national implementation reports, the
drafting by the Commission of an implementation report and possible follow-up
measures.

2.3.
Measures to prevent fraud and irregularities

This initiative does not involve any particular risk of fraud as it
only lays down procedural requirements to be followed by Member States in their
pharmaceutical pricing and reimbursement policies. The Commission will ensure
the overall management of the regulatory framework through administrative
involvement, subject to the Commission’s internal control standards.

3.
ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE
3.1.
Heading(s) of the multiannual financial
framework and expenditure budget line(s) affected

· Existing expenditure budget lines*

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Description........................................] || Diff./non-diff. ([17]) || from EFTA[18] countries || from candidate countries[19] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

Heading 1 || 02.03.01 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral aproximation || Diff || YES || NO || NO || NO

Heading 1 || 02.01.04.01 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation --- Expenditure on administrative management || Non-Diff || YES || NO || NO || NO

- Financial headings and budget lines will
need to be adapted to the new legal basis to be adopted under the financial
perspectives 2014-2020.

3.2.
Estimated impact on expenditure
3.2.1.
Summary of estimated impact on expenditure

EUR million (to 3 decimal places)

Heading of multiannual financial framework: || 1 || 1.a Competitiveness for growth and employment

DG: ENTERPRISE || || || Year N = 2014 || Year N+1= 2015 || Year N+2 = 2016 || Year N+3 = 2017 || Year N+4 = 2018 || ..... Action continued ..... || TOTAL

Ÿ Operational appropriations || || || || || || || ||

02.03.01 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation || Commitments || (1) || 0,645 || 0,735 || 0,585 || 0,585 || 0,585 || 0,585 || 0,585 || ...

Payments || (2) || 0,150 || 0,500 || 0,500 || 0,500 || 0,500 || 0,500 || 0,500 ||

Appropriations of an administrative nature financed  from the envelope for specific programmes[20] || || || || || || || ||

02.010401 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation — Expenditure on administrative management || || (3) || 0,050 || || || || 0,200 || || ||

TOTAL appropriations for DG ENTERPRISE || Commitments || =1+1a +3 || 0,700 || 0,735 || 0,585 || 0,585 || 0,785 || 0,585 || 0,585 || ...

Payments || =2+2a +3 || 0,150 || 0,500 || 0,500 || 0,500 || 0,700 || 0,500 || 0,500 ||

Ÿ TOTAL operational appropriations || Commitments || (4) || 0,645 || 0,735 || 0,585 || 0,585 || 0,585 || 0,585 || 0,585 ||

Payments || (5) || 0,150 || 0,500 || 0,500 || 0,500 || 0,500 || 0,500 || 0,500 ||

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || 0,050 || || || || 0,200 || || ||

TOTAL appropriations under HEADING 1 of the multiannual financial framework || Commitments || =4+ 6 || 0,700 || 0,735 || 0,585 || 0,585 || 0,785 || 0,585 || 0,585 ||

Payments || =5+ 6 || 0,200 || 0,500 || 0,500 || 0,500 || 0,700 || 0,500 || 0,500 ||

Heading of multiannual financial framework: || 5 || " Administrative expenditure "

EUR million (to 3 decimal places)

|| || || Year N = 2014 || Year N+1 = 2015 || Year N+2 = 2016 || Year N+3 = 2017 || Year N+4 = 2018 || ..... Action continued ..... || TOTAL

DG: ENTERPRISE ||

Ÿ Human resources || 0,159 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || ...

Ÿ Other administrative expenditure || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 ||

TOTAL DG ENTERPRISE || Appropriations || 0,209 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || ...

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0,209 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 ||

EUR million (to 3 decimal places)

|| || || Year N = 2014 || Year N+1 = 2015 || Year N+2 = 2016 || Year N+3 = 2017 || Year N+4 =2018 || ..... Action continued ..... || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 0,859 || 1,293 || 1,143 || 1,143 || 1,093 || 1,093 || 1,093 ||

Payments || 0,409 || 1,058 || 1,058 || 1,058 || 1,258 || 1,008 || 1,008 ||

Note: The financial resources required will
be met by the existing resources (internal market line) which are already
assigned to the management of the actions and/or by redeployment within the DG.

3.2.2.
Estimated impact on operational appropriations

–
ý  The proposal/initiative requires the use of operational
appropriations, as explained below:

Commitment appropriations in EUR million (to 3 decimal
places)

Indicate objectives and outputs ò || || || Year N=2014 || Year N+1=2015 || Year N+2=2016 || Year N+3=2017 || ..... Action continued ..... || TOTAL

OUTPUTS

Type of output[21] || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost

SPECIFIC OBJECTIVE : To continually develop existing internal market acquis and propose new legislative or non-legislative action whenever appropriate || || || || || || || || || || || || || || || ||

Translation || (A) || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || || ...

IT database || (B) || 0,15 || 1 || 0,15 || 0,6 || 0,09 || 0,6 || 0,09 || 0,6 || 0,09 || 0,6 || 0,09 || 0,6 || 0,09 || 0,6 || 0,09 || || ...

Transposition transposition || (C) || 0,15 || 0 || || 1 || 0,15 || 0 || || 0 || || 0 || || 0 || || 0 || || || 0,15

Sub-total for specific objective N°1 || || || || || || || || || || || || || || || ||

TOTAL COST || 2 || 0,645 || 2,6 || 0,735 || 1,6 || 0,585 || 1,6 || 0,585 || 1,6 || 0,585 || 1,6 || 0,585 || 1,6 || 0,585 || || ...

3.2.3.
Estimated impact on appropriations of an
administrative nature
3.2.3.1.
Summary

–
ý  The proposal/initiative requires the use of administrative
appropriations, as explained below.

EUR million (to 3
decimal places)

|| Year N =2014 || Year N+1 = 2015 || Year N+2 = 2016 || Year N+3 = 2017 || Year N+4 = 2018 || ..... Action continued ..... || TOTAL

HEADING 5 of the multiannual financial framework || || || || || || || ||

Human resources || 0,159 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || ...

Other administrative expenditure || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 ||

Subtotal HEADING 5 of the multiannual financial framework || 0,209 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || ...

Outside HEADING 5[22] of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other expenditure of an administrative nature || 0,050 || || || || 0,200 || || ||

Subtotal outside HEADING 5 of the multiannual financial framework || 0,050 || || || || || || ||

TOTAL || 0,259 || 0,558 || 0,558 || 0,558 || 0,758 || 0,558 || 0,558 || ...

3.2.3.2.
Estimated requirements of human resources

–
ý  The proposal/initiative requires the use of human resources, as
explained below:

Estimate to be expressed in full amounts (or at most to one decimal
place)

|| Year N= 2014 || Year N+1= 2015 || Year N+2= 2016 || Year N+3= 2017 || ..... Action continued .....

Ÿ Establishment plan posts (officials and temporary agents)

02 01 01 01 (Headquarters and Commission’s Representation Offices) || 0,159 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || ...

XX 01 01 02 (Delegations) || || || || || || ||

XX 01 05 01 (Indirect research) || || || || || || ||

10 01 05 01 (Direct research) || || || || || || ||

Ÿ External personnel (in Full Time Equivalent unit: FTE)[23]

XX 01 02 01 (CA, INT, SNE from the "global envelope") || || || || || || ||

XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) || || || || || || ||

XX 01 04 yy [24] || - at Headquarters[25] || || || || || || ||

- in delegations || || || || || || ||

XX 01 05 02 (CA, INT, SNE - Indirect research) || || || || || || ||

10 01 05 02 (CA, INT, SNE - Direct research) || || || || || || ||

Other budget lines (specify) || || || || || || ||

TOTAL || 0,159 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || ...

XX is the
policy area or budget title concerned.

The human resources required
will be met by staff from the DG who are already assigned to management of the action
and/or have been redeployed within the DG, together if necessary with any
additional allocation which may be granted to the managing DG under the annual
allocation procedure and in the light of budgetary constraints.

Description of
tasks to be carried out:

Officials and temporary agents || Overall management of the Directive (coordination with Member States, organisation of consultative committee, legal interpretation, infringement procedures, etc.), assessment of draft national measures notified to the Commission, secretarial and administrative support.

External personnel || --

3.2.4.
Compatibility with the current multiannual
financial framework

–
ý  Proposal/initiative is compatible the current multiannual
financial framework.

–
Financial headings and budget lines will need to
be adapted to the new legal basis to be adopted under the financial
perspectives 2014-2020

–
 ̈  Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

Note:

Financial headings and budget lines will need to be adapted to the new
legal basis to be adopted under the financial perspectives 2014-2020.

3.2.5.
Third-party contributions

–
ý The proposal/initiative does not provide for co-financing by third
parties

|| || || || || || || ||

3.3.
Estimated impact on revenue

–
ý  Proposal/initiative has no financial impact on revenue

[1]               See
Directive 2001/83/EC of the European Parliament and the
Council of 6 November 2001 on the Community code relating to medicinal products
for human use (OJ L311,
28/11/2001, p. 67), as amended, and Regulation (EC) N°726/2004 of the European Parliament and of the Council of 31 March 2004
laying down Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a European
Medicines Agency (OJ L 136, 30.4.2004, p. 1).

[2]               See,
for instance, Case 181/82 Roussel Laboratoria [1983] ECR 3849; Case 238/82 Duphar
and Others [1984] ECR 523; Case C‑249/88 Commission v Belgium [1991] ECR
I-1275.

[3]               Council
Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures
regulating the pricing of medicinal products for human use and their inclusion in
the scope of national health insurance system (OJ N°40, 11.2.1989, p. 8).

[4]               See
Case C-424/99 Commission
of the European Communities v Republic of Austria [2001] ECR 9285; Case C-229/00 Commission of the European Communities v Republic of
Finland [2003] ECR 5727; Case C-317/05 Pohl-Boskamp
[2006] ECR I-10611; Joined Cases C‑352/07 to C‑356/07, C‑365/07
to C‑367/07 and C‑400/07 Menarini Industrie Farmaceutiche Riunite
and Others, nyr; Case C‑62/09
Association of the British Pharmaceutical Industry v Medicines and Healthcare
Products Regulatory Agency, nyr.

[5]               Commission
inquiry into the European pharmaceutical sector pursuant to Article 17 of
Regulation 1/2003. The results of the inquiry are published in the
Communication from the Commission: “Executive Summary of the Pharmaceutical
Sector Inquiry Report” (COM(2009)351 final) and the annexed Staff Working
Document: “Report on the Pharmaceutical Sector Inquiry”. http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html.

[6]               Case
C‑245/03 Merck, Sharp & Dohme [2005] ECR I‑637, point 27.

[7]               OJ
C , , p. .

[8]               OJ
L 40, 11.2.1989, p. 8.

[9]               OJ L 311, 28.11.2001, p. 67.

[10]             COM(2009)
351 final.

[11]             OJ
L 395, 30.12.1989, p. 33.

[12]             OJ L 76, 23.3.1992, p. 14.

[13]             OJ L 134, 30.4.2004, p. 114.

[14]             OJ L 88, 4.4.2011, p. 45.

[15]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[16]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html.

[17]             Diff.
= Differentiated appropriations / Non-diff. = Non-Differentiated Appropriations.

[18]             EFTA:
European Free Trade Association.

[19]             Candidate
countries and, where applicable, potential candidate countries from the Western
Balkans.

[20]             Technical and/or administrative assistance and expenditure
in support of the implementation of EU programmes and/or actions (former
"BA" lines), indirect research, direct research.

[21]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.). (A) =
translation work, (B) = IT support, (C)= Services – Verification of
transposition.

[22]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[23]             CA=
Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune
Expert en Délégation" (Young Experts in Delegations); LA= Local Agent;
SNE= Seconded National Expert.

[24]             Under the ceiling for external personnel from operational appropriations (former
"BA" lines).

[25]             Essentially
for Structural Funds, European Agricultural Fund for Rural Development (EAFRD) and
European Fisheries Fund (EFF).