On Saturday 19 October, the Spanish Official Gazette published the
long-awaited royal decree on the distribution of medicines for human use
(Royal Decree 782/2013 of 11 October, the “New RD”).
The wording of the New RD is practically identical to the last draft
published by the Ministry of Health almost a year ago, in November 2012.
Royal Decree 2259/1994, which had been obsolete for many years, is
repealed to give way to a new regulation that is more in line with the
current safety requirements for the distribution of medicines. The New
RD incorporates into Spanish law the changes brought in the framework of
the distribution of medicines by the new EU regulations on preventing
falsified medicines entering the supply chain and pharmacovigilance.
More stringent safety requirements for the manufacture and
distribution of active ingredients are put in place to tackle serious
public health risks posed by their falsification or inadequate
manufacturing or distribution. In this regard, Royal Decree 824/2010 of
25 June on pharmaceutical laboratories, manufacturers of active
ingredients for pharmaceutical use and foreign trade in medicines and
investigational medicinal products is amended.
We highlight the most significant aspects of the New RD:
1. purpose and scope
Although already operating in the medicine distribution market,
entities known as medicine brokers were not subject to control or
regulation; this has been remedied by the New RD.
The New RD covers all entities involved in the distribution of
medicines: (i) wholesalers; (ii) third party warehouses (almacenes
por contrato); and (iii) warehouses under customs control or
surveillance (almacenes de medicamentos bajo control o vigilancia
aduanera).
In the context of distribution, the right of pharmaceutical companies
established in Spain to directly sell their products is recognized in
the New RD. The obligations and requirements to be observed by these
pharmaceutical companies to directly sell their products are similar to
those that must be met by distributors in terms of general principles
and operating requirements.
Pharmaceutical companies established in another Member State that
hold marketing authorizations for medicines (or their local
representatives in Spain) must carry out their wholesale distribution
activities in Spain through entities authorised to do so.
All agents involved in the distribution of medicines must seek to
ensure good distribution practices are complied with. According to the
New RD, the good distribution practices will be published by the
Ministry of Health (and will surely be aligned with those of the EU[1]).
Lastly, the New RD provides that, besides a distribution authorisation,
distributors must hold an in-date certificate of compliance with good
distribution practices. This certificate will be issued by the relevant
health authority, although the New RD does not clarify if the national
or regional health authorities will be responsible for these
certificates.
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2. supply and delivery
Unlike in its draft versions, the New RD does not establish an
obligation on pharmaceutical companies to guarantee the supply of
medicines to “all authorised wholesalers”. In line with recent
case law, to do so would have been contrary to Law 29/2006 of 26 July on
Guarantees and Rational Use of Medicinal Products and Medical Devices (the
“Guarantees Law”).
Article 68 of the Guarantees Law has been developed by the New RD to
require pharmaceutical companies and distribution entities to guarantee
that pharmacies are supplied “to ensure that patient needs are
covered”.
Furthermore, the New RD defines the situations in which the AEMPS (Spanish
Agency of Medicines and Medical Devices) may adopt measures to resolve
shortage situations, including limiting exports of medicines outside of
Spain. These measures may be applied to medicines that, owing to their
active ingredient, dosage or route of administration, are the only ones
registered in Spain for a certain pathology, or to those for which there
is no alternative available to pharmacists.
The New RD also establishes a restriction of unquestionable practical
importance which means that wholesalers and pharmaceutical companies
will only be able to accept returns from pharmacies and pharmaceutical
services that were (directly) supplied with the medicines being returned.
The aim of this measure is to bring to an end a system that created
opportunities for medicine trafficking.
The New RD finally develops article 2.5 of the Guarantees Law on
direct sales of medicines to professionals, although with limitations as
these sales will only be possible through pharmacies. The AEMPS must now
publish on its website a list of all the medicines that may be directly
sold to professionals.
3. OPERATING requirements
In line with the repealed Royal Decree 2259/1994, the New RD sets out
some of the basic operating requirements to be met by distributors. For
example, they must comply with delivery terms and minimum delivery
frequencies so as to guarantee that pharmacies and pharmacy services
receive medicines ordered within 24 hours.
The operating requirements established for brokers mainly relate to
transparency and the need for them to manage the information related to
their transactions adequately.
4. BROKER And distribution activities
Brokers do not need to obtain an authorisation prior to carrying out
distribution activities (nor do pharmaceutical companies established in
Spain). Brokers only need to notify the AEMPS their contact details and
request their inclusion in the registry of medicine brokers.
In connection with the authorisation that distribution entities must
obtain before they begin operating, the New RD establishes a term of 90
days to notify the applicant of the approval or denial of the
authorisation. If the authorities do not issue a decision within this
term, the authorisation can be assumed granted.
[1] Directive 2011/62/EU of
the European Parliament and of the Council of 8 June 2011 and Guidelines
of 7 March 2013 on Good Distribution Practice of Medicinal Product for
Human Use.
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1.
purpose and scope