LEADERSHIP STATEMENT
As industry leaders, we are committed to working in partnership with all stakeholders
to improve healthcare across Europe.
In doing so, we are conscious of the importance of providing accurate, fair andobjective information about our medicines to allow rational decisions to be madeabout their use. As such, we fully respect the role that EU legislation1 plays inregulating interactions between pharmaceutical companies and healthcare
professionals.
In this same spirit, we are committed to working towards greater transparency,
accountability and ethical behaviour within an industry framework of self regulation.
Our companies have already adopted EFPIA Codes establishing standards forappropriate behaviour in our relations with healthcare professionals and with patientorganisations2.
We believe that adherence to these Codes is essential. Breaches should not betolerated.
Recognising however that society has particularly high expectations of our industry,
we have today asked EFPIA to develop additional guidance around the following
areas to ensure that our industry continues to uphold the highest standards.
1. Provision of information
2. Medical sales representatives
3. Medical samples
4. Congresses and other meetings, including exhibitions at congresses
5. Relationships with patient organisations
We have asked that this guidance be made available during the second part of2010.
Today, we have also called for the establishment of National Ethics Groups in EFPIA’s
31 member associations.3 These Groups will further ensure effective oversight of1

Title VIIIa of Directive N° 2001/83/CE

2“Code on the Promotion of Prescription-only Medicines to, and Interactions with, Healthcare Professionals”(EFPIA’s HCP Code) and the “Code of Practice on Relationships between the Pharmaceutical Industry andPatient Organisations” (EFPIA’s PO Code) – see www.efpia.eu

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EFPIA’s member associations represent (R&D-based) pharmaceutical companies operating in: Austria,Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland,
Portugal, Spain, Sweden, Switzerland, Turkey and the United Kingdom, as full members; and Albania,
Bulgaria, Croatia, Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Romania, Serbia,Slovakia and Slovenia, as affiliate members.

1industry standards, as well as implementation of the new Guidance within one yearof its issuance.
Going forward we will continue to challenge ourselves to exceed society’sexpectations and we welcome suggestions from others regarding how we might
further strengthen confidence in our industry and our companies’ behaviour.
We also invite companies that are not within EFPIA’s (direct or indirect) membershipto adhere to the self-regulatory rules and guidance adopted by the R&D-basedindustry.

Brussels, June 24th 20102

1. Provision of information
Directive Article 88a:... the Commission shall ...
report on practice withregard to information
provision ... and its risks
and benefits for patients.
... the Commission shall ...
put forward proposals
setting out an
information strategy ...

We, leaders of the industry, believe European
citizens should have equal access to high-quality
information on health and prescription medicines,
including information provided by industry on
diseases and treatments they have researched.
We therefore believe that the R&D-based
pharmaceutical industry has a legitimate role toplay in the ongoing debate around the provision ofsuch information.
We have therefore asked EFPIA to answer any callsfrom the EU Institutions to contribute constructively
to the debate on the provision of information.

2. Medical sales representatives
Directive Recital 49

Medical sales
representatives have an
important role in the
promotion of medicinal
products. Therefore,
certain obligations
should be imposed onthem ...

Article 17 of EFPIA HCP
CodeMedical sales representatives are an importantsource of information to prescribers. They have asensitive role to play in providing timely and highquality information while ensuring that theirpractices do not impair patients’ access tohealthcare professionals.
All EFPIA member associations must follow highstandards for the appropriate training of sales
representatives in scientific matters. Medical sales
representatives must also comply with industry
ethical rules.
Building on existing legal obligations and industry
standards, we, leaders of the industry, ask EFPIA toprovide guidance for defining standards and housekeeping rules for medical sales representatives.

33. Medical samples
Directive Article 96:
Free samples shall be
provided on an
exceptional basis only ...

Medical samples are provided to healthprofessionals so that they may familiarise themselveswith the medicines and acquire experience indealing with them. Samples of a medicine shall only
be given in response to a written request fromhealth professionals qualified to prescribe thatparticular medicine. Samples should however not
be given for the sole purpose of treating patients.
The EU Directive limits sampling to “exceptional”
cases; this means that in principle, no samples
should be given, except on an exceptional basis.
There are still important disparities in the provision ofmedical samples across Europe.
We, leaders of the industry, consider that it isreasonable that each healthcare professional
should receive, per year, no more than 4 samples ofa particular medicine he / she is qualified toprescribe; and that sampling should not extend
beyond the two years after the product is firstlaunched.

Article 16 of EFPIA HCP
CodeTherefore, we have asked EFPIA and its member
associations to support (self-)regulation moves
towards this “4 x 2” standard.

4. Congresses and other meetings, including exhibitions at congresses
Directive Article 94:...
Hospitality at sales
promotion events shallalways be strictly limited
to their main purposeand must not be
extended to persons
other than healthcare
professionals.

Promotional, scientific or professional meetings
include – but are not limited to – congresses,
conference, symposia, advisory board meetings,
training meetings, investigator meetings for clinical
trials and non-interventional studies, etc. Throughsuch events, pharmaceutical companies
contribute to continuous medical education ofhealthcare professionals and scientific informationexchange between the attendees and between
these and industry representatives.
Any practice that might create confusion about
the real scientific and educational purpose ofthese events should not be tolerated.
We, leaders of the industry, have asked EFPIA to4

...

Article 9 of EFPIA HCP
Codedevelop common standards for meetingsorganised / sponsored by industry and attended
by healthcare professionals.
We have also asked that EFPIA coordinate
monitoring of European events, by setting up an
on-line platform to pre-assess events in regard ofEFPIA’s HCP Code. Reports will be shared withcorporate compliance officers, the National Ethics
Groups, and congress and meeting organisers topromote compliance with industry standards.
EFPIA is also asked to work with medical andscientific societies to raise awareness of the highethical standards applying to interactions
between medical doctors and pharmaceuticalcompanies.

Considering that congresses are a vital forum
where R&D-based pharmaceutical companies
can present data and interact with scientificexperts, industry leaders stress that it is critical thatexhibitions at congresses do not over-shadow themain purpose of scientific events. In this respect,
EFPIA HCP Code provisions relating to events andhospitality (Article 9) and gifts (Article 10) apply toexhibitions at congresses.
Articles 9 & 10 of EFPIAHCP Code

In recognition of this, we, leaders of the industry,
have asked that EFPIA coordinate the monitoringof congress activities – including exhibitions atcongresses, drawing company complianceofficers to problematic behaviour, exerting peerpressure through site visits at congresses. Congressorganisers would receive notice of planned visits.

55. Relationships with patient organisations
EFPIA Code on
Relationships between
the PharmaceuticalIndustry and Patient
Organisations
Article 5.a.
(Transparency)

Each company must
make publicly available
a list of patientorganisations to which it
provides financial
support and / orsignificant indirect / nonfinancial support. ...

The pharmaceutical industry recognises that it has
many common interests with patient organisations,which represent and / or support the needs ofpatients and / or caregivers.
As an additional step towards increasedtransparency, we, leaders of the industry, have
instructed EFPIA to review its PO Code with a view torequiring mandatory disclosure of financial andsignificant indirect / non-financial support to patientorganisations. The total amounts of support
provided to patient organisations should include: (i)the amount of financial support; (ii) the amount ofcost invoiced to the sponsoring company forsignificant non-financial support; (iii) for significant
indirect support not covered by invoices and forsignificant non-financial support, the sponsoring
company will provide its best estimate established ingood faith of costs incurred. EFPIA may also
consider providing additional guidance on theformat of disclosure of support.

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