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Distance sales of medicinal products, the legal framework: EU
Directive 2011/62/EU
Beln Escribano Head of the Pharmaceutical Inspection and
Enforcement Department
OTC Medicines: the role of good classification practices in
promoting medication safety and accessibility in Europe Zagreb,
20-21 November 2014
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Presentation outline
Some background information (Directive 2000/31/CE &
DocMorris case)
EU distance sales legal frame
Some questions for the future
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An increasing activity in Spain (and everywhere!): 11.369,6
millions of every year 14,7% increase in relation with the previous
period
Quaterly bussiness increase from 2009 2013.
* Information supplied by the Internet Observatory
(AECOSAN-MSSSI-Spain )
E-Commerce *, some data
And medicinal products are also sold in Internet!
PrsentateurCommentaires de prsentationGrfico de Fundacin
Telefnica - La Sociedad de la Informacin en Espaa 2013
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Remove obstacles to cross-border online services in the internal
market Provide legal certainty to business and citizens Offer a
flexible, technically neutral and balanced legal framework
Enhancing competitiveness of European service providers
Directive 2000/31/EC, 'Directive on electronic commerce'
Objectives
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The Directive applies horizontally across all areas of law which
touch on the provision of information society services (ISS)
Substantive rules:
internal market clause, but between the reasons for derogation
the protection of public health is included (Article 3)
principle excluding prior authorisation for establishment
(Article 4) general information requirements (Article 5)
This Directive complements other EU legislation (e.g. distance
sales directive, professional qualifications directive)
Some general aspects (Directive 2000/31/EC)
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Apothekerverband eV (plaintiff): professional organization of
pharmacists in Germany (pharmacy council)
DocMorris (defendant): pharmacy in The Nederlands selling
(prescription and non-prescription) medicines over the Internet to
German citizens
Lawsuit in Germany for unfair competition and infringement of
German regulations (sales, advertising)
DocMorris and Mr Waterval were offering for sale, at an Internet
address prescription and non-prescription medicines for human use,
in languages including German, for end consumers in Germany
The defendants in the main action sold only authorised
medicines, some of which have been authorised in Germany and others
in the Netherlands
DocMorris ruling. Jurisprudence ECJ: Case C-322/01 0800
Deutscher Apothekerverband eV vs DocMorris NV and Jacques
Waterval.
PrsentateurCommentaires de prsentationApothekerverband, el
reclamante, es una asociacin profesional de los farmacuticos en
Alemania.DocMorris es una farmacia (real y en internet) autorizada
en Holanda, que vende medicamentos de prescripcin y sin prescripcin
a consumidores finales en Alemania.
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Is German regulation contrary to the principle of
free movement of goods, does it constitute a measure having
equivalent effect (Art. 28 EC)?
Is national prohibition justified on the grounds of
protecting public health (even if a prescription is
presented)?
Does it matter if (imported) medicines are licensed
or unlicensed in Germany?
Questions? (DocMorris ruling)
PrsentateurCommentaires de prsentationApothekerverband, el
reclamante, es una asociacin profesional de los farmacuticos en
Alemania.DocMorris es una farmacia (real y en internet) autorizada
en Holanda, que vende medicamentos de prescripcin y sin prescripcin
a consumidores finales en Alemania.
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General prohibition to place in the market unauthorised
medicines (irrespective of the selling channel).
Some consequences (DocMorris ruling)
It is possible for a Member State to decide that only non
prescription medicinal products can be sold at a distance to the
public in the Member State concerned
PrsentateurCommentaires de prsentationApothekerverband, el
reclamante, es una asociacin profesional de los farmacuticos en
Alemania.DocMorris es una farmacia (real y en internet) autorizada
en Holanda, que vende medicamentos de prescripcin y sin prescripcin
a consumidores finales en Alemania.En los razonamientos del
tribunal se reconoce que la venta de medicamentos a los
consumidores finales (retail supply/sale to end consummers) no ha
sido objeto de armonizacin a nivel Comunitario. Sin embargo, las
medidas que pueden restringir estas ventas son slo compatibles con
el tratado en tanto estn justificadas para la proteccin de la salud
y la vida de los consumidores.El estatus (sujeto/no sujeto a
prescripcin) se decide conjuntamente con la autorizacin, por lo que
puede quedar bajo la competencia del EM que emita la
autorizacin.
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Active substances and excipients
Distribution of medicinal products
Safety features Internet
Directive 2011/62/EU of the European Parliament and of the
Council, of 8 June 2011 amending Directive 2001/83/EC on the
Community code relating to medicinal products for human use, as
regards the prevention of the entry into the legal supply chain of
falsified medicinal products
Main changes are related to:
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Requirements for the distance sales on the UE System to identify
the legal websites: common logo Additional conditions may be
imposed by Member States, justified
on grounds of public health protection Need of consumers raising
awareness campaigns about the risks
related to medicinal products supplied illegally
Sales at a distance Directive 2011/62/EU: content
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Requirements:
Who?
What ?
Where?
As well as the system to make safer these sales
Title VIIA Sale at a distance to the public (Directive
2011/62/EU)
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1. Persons offering the medicinal products (who):
Authorisation to supply medicinal products to the public
according to the national legislation of the Member State in which
that person is established
Notification to the Member State in which that person is
established the required information (and keep it updated) : name
permanent address starting date of the activity address of the
website used for that purpose relevant information necessary to
identify that website the classification in accordance of the
medicinal products offered, if applicable
2. Medicinal products (what):
In compliance with the national legislation of the Member State
of destination
Requirements for the sale at a distance to the public (1/2)
(Directive 2011/62/EU)
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3. Websites offering the sale at a distance (where):
Information requirements of Directive 2000/31/EC
Contact details of the competent authority
Hyperlink to the website of the Member State of
establishment
Common logo with a hyperlink to the list published by the
competent
authority
Requirements for the sale at a distance to the public (2/2)
(Directive 2011/62/EU)
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National legislation applicable Purpose of the common logo List
of persons offering the medicinal products for sale at a
distance Risks related to medicinal products supplied
illegally
These websites will be inter-linked
NCAs and EMA websites information (Directive 2011/62/EU)
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Name of authorised person
Address Starting date of the activity
Website address Notification
process
Request for additional information, if needed
Assessment of the information
Approval Person included by the NCA on the public list of
persons offering medicinal products for sale of at a distance to
the public
The logo will be sent to this person
Listed
The future system
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Common EU Online Pharmacies logo (Regulation No 699/2014 of 24
of June 2014)
Visual means to help patients identify whether a website belongs
to a person listed at its NCA
Hyperlinks to NCA and EMA websites where patients can check that
the website of the person is legal
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Would it be posible to sale other kind of products in the same
website?
And a common website or domains, could be used by several
pharmacies?
Do we all have the same interpretation of authorised medicinal
product when the country of destination is different from the one
where the sale takes place and the medicinal product is authorised
in both MMSS?
Which conditions will apply on the sales to other MMSS where the
legislations are different?
Some questions about these future sales
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