Distance sales of medicinal products,

the legal framework: EU Directive 2011/62/EU

OTC Medicines: the role of good classification practices
in promoting medication safety and accessibility in Europe
Zagreb, 20-21 November 2014
Beln Escribano
Head of the Pharmaceutical Inspection and Enforcement Department

Presentation outline
Some background information
(Directive 2000/31/CE & DocMorris case)
EU distance sales legal frame
Some questions for the future

E-Commerce *, some data

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.

And medicinal products are also sold in Internet!

* Information supplied by the Internet Observatory (AECOSAN-MSSSI-Spain )

Directive 2000/31/EC, 'Directive on electronic commerce'

Objectives

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

Some general aspects (Directive 2000/31/EC)

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)

DocMorris ruling. Jurisprudence ECJ: Case C-322/01 0800

Deutscher Apothekerverband eV vs DocMorris NV and Jacques
Waterval.
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

Questions? (DocMorris ruling)

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?

Some consequences (DocMorris ruling)

General prohibition to place in the market unauthorised

medicines (irrespective of the selling channel).

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

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:

Active substances and excipients

Distribution of medicinal products
Safety features
Internet

Sales at a distance Directive 2011/62/EU: content

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

Title VIIA Sale at a distance to the public (Directive 2011/62/EU)

Requirements:
Who?
What ?
Where?
As well as the system to make safer these sales

Requirements for the sale at a distance to the public (1/2)

(Directive 2011/62/EU)
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 (2/2)

(Directive 2011/62/EU)
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

NCAs and EMA websites information (Directive 2011/62/EU)

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

The future system

Name of
authorised person
Address
Starting date of
the activity
Website address

Notification
process

Approval
Request for additional
information, if needed
Assessment of the
information

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

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

Some questions about these future sales

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?