This document provides an overview of pharmaceutical regulation in Ireland and Europe. It discusses the increasing regulation of the pharmaceutical industry driven by crises like Thalidomide and the goal of protecting patients and consumers. The document also outlines Ireland's pharmaceutical industry, which has grown significantly over the past 50 years from exporting less than €100 million to €3 billion in taxes annually. It provides context on the regulatory framework the industry operates within, including various codes and legislation at the EU and Irish levels. The document focuses on IPHA codes for self-regulation and their requirements regarding promotional practices and interactions with healthcare professionals.

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Guide to complying with Version 8.1 of the Code
of Practice for the Pharmaceutical Industry
Rebecca Cramp PhD,
Scientific & Regulatory Affairs Manager

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Status
2015
50 YEARS OF PHARMACEUTICAL LEGISLATION
50 years since Directive 65/65

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The Pharmaceutical Industry and its
Regulatory Framework
1. Brief overview of the Industry
2. The regulatory framework
3. Pharmaceutical legislation: EU & Irish
5. What the future holds
6. Useful websites

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Increasing Regulation – A Challenge
Prior to 1960s: Few controls on pharmaceuticals
Now: EU Directives, Regulations,
Guidelines, Court of Justice …
National Legislation & Guidelines
Drivers of increased regulation:
 Thalidomide crisis in 1960s
 Single Market in Europe & EU enlargement
 Increasing focus on the rights of patients & consumers

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Facts & Figures about R&D
 Pharma industry develops 90% of new medicines
 1-2 out of every 10,000 potentials make it to market
 Average time to bring new drug to market = 12-13 yrs

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Facts & Figures about R&D
 On average 8 years effective patent protection
 1975: €149 million; 2012: >€1.4 billion to develop new
drug
 3/10 marketed medicines produce revenue > R&D costs
Source: IPHA Healthcare Facts & Figures, 2012: www.ipha.ie (last year of F&F publication)

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Ireland’s Pharmaceutical
Industry… How it changed
19731973
Exports less that €100 millionExports less that €100 million
Employment less than 2,000Employment less than 2,000

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Exports less that €100 millionExports less that €100 million
Employment less than 2,000Employment less than 2,000
Ireland’s Pharmaceutical
Industry… recent times
19731973
20122012
120 companies (13 of top 15
pharmaceutical companies worldwide)
Employs 24,500 - 50% of employees,
third level qualification
IDA Ireland: Replacement value of
investment by pharma sector in Irish
economy exceeds €40 billion
€3 billion in Taxes annually & €7 billion
invested in last decade
Irish consumption of medicines remains
amongst the lowest in Western Europe

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The Need for Continued Medicines Innovation

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THE REGULATORY FRAMEWORK FOR
PHARMACEUTICALS

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Context in which the
pharmaceutical industry operates
 Legal regulations
– Bound by EU and Irish Laws
 Industry requirements
– IPHA Code (Ireland)
– EFPIA Code (EU)
– IFPMA Code (global)
Enhanced societal expectations
and scrutiny of businesses,
generally, and of the healthcare
industry, specifically

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EU and Irish Legislation
EU Legislation
 Directive 2001/83/EC as amended by 2004/27/EC, 2008/29/EC...
Irish Legislation (23.07.07)
 Medicinal Products (Control of Advertising) Regulations, 2007 (SI541)
 Medicinal Products (Control of Wholesale Distribution) Regs, 2007, SI538*
 Medicinal Products (Control of Manufacture) Regs, 2007, SI539*
 Medicinal Products (Control of Placing on the Market) Regs, 2007, SI540*
*as amended

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Legislation of Self-Regulation
IPHA Codes fit into the general framework established by
Article 97, para 5 of Dir 2001/83/EC as amended, which
recognizes the role of the voluntary control of
advertising of medicinal products by self-regulatory
bodies and recourse to such bodies.
The Minister for Health, as provided for under Reg 26 of
the Medicinal Products (Control of Advertising) Regs 2007,
as amended, also endorses the sections of the Code that
are derived directly (verbatim) from the aforementioned
legislation.

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IPHA Codes
Two IPHA Codes for self-regulation in Ireland
• Code of Practice for the Pharmaceutical Industry
• Code of Standards of Advertising Practice for the Consumer
Healthcare Industry
Requirements within come from
• Irish and European legislation
• Regulator (Health Products Regulatory Authority)
• European Association (EFPIA)
Generic manufacturers adhere to their own Code

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Version 8.1 – Main changes
Body of the Code
Addition of new clause that clarifies existing practices regarding the
provision of patient support items to HCPs (Clause 4.9)
Annex V
HCO Definition clarified Section 1 of Annex V
ToV disclosure on company website/central platform
Version 8.0 of the Code only required public disclosure of ToVs, it
did not specify location /format. Version 8.1 requires that
information be placed on a company website or central platform.
(Section 2.1 of Annex V)
Inclusion of EFPIA template for disclosure of ToV (Section 5.0 of Annex V)

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Clause 1.1
The Code covers
interactions with HCPs, HCOs and PAs &
promotion to HCPs of Rx medicinal products

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Definition: Promotion (Clause 1.2)
Those marketing & informational activities coming
under the control or authority of the company, the
purpose of which is to induce the prescribing,
supply, sale or consumption of the company’s
products
Examples:
– Activities of Medical Representatives
– Journal and direct ‘mail’ advertising through post, telephone,
email, internet, ipad etc…
– Use of films, videos, data storage devices,
– Exhibitions (conference stands etc…)
– Press releases referring to a product
– Provision of samples or hospitality

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Marketing Authorisation (MA)
 A product cannot be promoted prior to MA being
granted (3.1) and the promotion must be consistent
with the terms of the MA (3.2)
Exception for international conferences / symposia
held in Ireland (3.3) if
– Product is authorised in at least one MS of the EEA
– Truly international scientific event
– Visible, legible statement on promotional material that not
authorised/ authorised for different indications in Ireland
– Promotion material referring to Rx information in other MSs
states that licensing conditions differ internationally

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Nature & Availability of Info (Clause 4)
Covers two situations:
 Product info supplied by a company to HCPs
 Information to substantiate claims in promo material
Information about medicinal products must be:
 up-to-date, verifiable and accurately reflect current knowledge or
responsible opinion (Clause 4.2)
 accurate, balanced, fair, objective and must not mislead either
directly or by implication (Clause 4.3)
 capable of substantiation (Clause 4.4)

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4.8: Education / Information
Informational/education material permitted if
Inexpensive
Directly relevant to practice of medicine/pharmacy
Directly beneficial to patient care
Pens/paper at company organised meetings if
No product branding
Inexpensive
Other meetings
No pen/paper distribution at exhibition stands
No product/company brand on pens/paper in conference bags

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New Clause 4.9
Items given to HCPs to be passed on to patients
− May have the medicine name (and/or information about the
medicine) only if such detail is relevant
− May be exhibited (but not provided) at HCP stands
− Can be provided to the HCPs by medical reps

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Items of Medical Utility
- renumbered & branding clarified
Items of medical utility aimed directly at education
of HCPs and patient care acceptable if
Inexpensive
Do not offset cost of routine business practice
May be company branded
Product branding might be acceptable when item
is used with that medicine

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Claims & Comparisons (Clause 5)
Claims for the usefulness of a
medicine must be based on an
up-to-date evaluation of all the
evidence and reflect it accurately
and clearly.
Claims must have prior medical
review and approval (Clause 5.1)

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Claims & Comparisons
Avoid exaggerated claims, all-embracing claims
and superlatives. Do not suggest the product or an
active ingredient has some special merit or quality
unless capable of substantiation (Clause 5.2)
Factual, fair comparisons capable of
substantiation. Comparisons must not mislead by
distortion, undue emphasis, omission or any other
way (Clause 5.5)

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Disparaging References (Clause 6)
Other companies, their products, services or
promotions must not be disparaged either
directly or by implication (Clause 6.1)
– Cannot selectively use information about another
product to present it less favourably than yours;
– If you choose to compare on price, you must ensure
advertising copy remains up to date throughout its
useful life. Source should be provided

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Text and audio-visual material
(Clause 7)

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Detail
 All material issued by MAH (or under
his/her authority) must be consistent
with the Code (Clause 7.1)
 Full Ad (Clause 7.2)
(may contain claims)
 Reminder Ad (Clause 7.3)
(may not contain claims)

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Minimum Info for Reminder Ad to HCPs
The following info MUST be given clearly and legibly:
The name of the medicinal product, or the international non-
proprietary name or the trademark
Further information is available upon request / in SmPC
Name and address of PA holder/ business name & address
of part of business placing medicine on market
Classification for sale or supply of the product
The precise indication for the product may also be provided –
but no claims

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Minimum Info for Full Ad to HCPs
Following info must be provided clearly and legibly:
i. PA number & name and address of PA holder
ii. Name of the product
iii. List of the active ingredients, using the common name, placed
next to the name of the product
iii. One or more of the indications for use
iv. Recommended dosage, method of use and, where not obvious,
method of administration
v. Sale or supply classification
vi. Adverse reactions, warnings and precautions for use and
relevant contraindications
vii. Statement that additional information is available on request
viii. Date of last update

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Code Council Findings
• July 2009: Advertising Agency had prepared and provided a Medical
Press Release which clearly identified the Respondent’s product by its
brand name and generic name but not provided all the information
required by Clause 7.2 (full ad requirements)
• 2011: Editor’s attendance at conference supported by Respondent &
editor published an unbalanced ‘promotional’ article on their products in
a medical journal. Finding: ‘while an Editor has his or her special
editorial responsibilities, the exercise of which should remain
independent...the provision of support, in any form, by a pharmaceutical
company automatically entails the observance of the Code.

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Detail
 Mailings & Journal Advertisements (Clause 7.4)
– Not designed to disguise real nature
– If company pays/secures/arranges promotional material
publication in journal – must not resemble editorial matter
Code Complaint upheld in 2011:
– Piece published in a medical journal did mention that the
author was a medical advisor to the Respondent
– No declaration that the piece was sponsored by the
Respondent, thereby giving impression of independent
editorial, in breach of Clause 7.4 of the Code
– Code Council required publication of a corrective statement

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Requirements
• Clause 7.5: All promotional material in journals, under the control
of a company & referring by brand name to one of its products must
comply with Clauses 7.2 and 7.3 irrespective of editorial control
• Clause 7.6: Promotional material must conform to canons of good
taste, “respect professional standing of recipients” and “not be
likely to cause offence.”
• Clause 7.7: The names/photos of HCPs only used with permission
& not contrary to their ethical code
• Clause 7.8: Imitation: must not imitate the devices, copy,
slogans or general layout of other companies in a way likely to
mislead or confuse

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Requirements ctd
• Date: Where appropriate date of printing /last review (7.9)
• Extremes of format, size or cost avoided (7.10)
• Public Advertising: Postcards/exposed mailings/ envelopes/
wrappers must not carry advertising matter to the public/ unsuitable
for public view (7.11)
• Audio-visual should be accompanied by appropriate printed material
to ensure Code compliance (7.12)
• Need to ensure that text appearing as part of a visual does not
imply any unacceptable claims

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References to
Regulatory Authority (Clause 8)
Reimbursement System (Clause 9)

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References
 Not permitted to claim marketing recommendation
by HPRA or European Medicines Agency (EMA)
 Statement such as “PCRS Reimbursable” limited
to the first 12 months
 No other references to PCRS (ex GMS) except for
relevant code number

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Distribution of Promotional
Material
 Material tailored to the audience (10.1)
 Exercise restraint in frequency & volume of material
distributed - avoid elaborate & expensive material (10.3)
 Mailing list kept up-to-date & names removed upon
request (10.4)
 Electronic means of communication only used for material
distribution on an opt-in basis (10.5)

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Reprints, Abstracts & Quotations (Clause 11)
In addition to the Copyright laws the following
requirements apply:
 Mass mailing of reprints must comply with Clauses 7.2/7.3
i.e. full /reminder ads (Clause 11.1)
 Quotations from, abstracts of, or accurately reproduced
tables/graphs from scientific literature which are
adequately referenced (Clause 4.6) may be included, but
author’s name not be used prominently (Clause 11.2)
 Do not misquote from articles or personal
communications from HCPs (Clause 11.3)

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Pharmaceutical Company Employees
(Clause 12)
 Companies responsible for all employees (12.10)
 Companies must ensure that those involved in drafting/
approval of promotional material are conversant with Code
 Third parties or those working as licensee or joint venture
need a good working knowledge of the Code.
 Ensure all regulatory obligations are met. Notify / involve
company PhV departments regarding market research,
Patient Support Programmes etc (12.12)

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Requirements for Medical Reps
 Be trained so as to be able to present product
information in an accurate, complete and responsible
manner (Clause 12.2)
 Make the SmPC available to HCPs or refer to the
compendium www.medicines.ie (Clause 12.3)
 Report any adverse event to the Scientific Services of
their company (Clause 12.4)
 Not employ any inducement or subterfuge to gain
access to HCP. No payment for access (Clause 12.6)
– This clause does not preclude the occasional provision of light
refreshments/modest meals at a meeting organised by a
medical rep. Payments to HCPs to cover the cost of such meals
is not permitted.

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Medicines.ie
 Internet traffic continues to increase
– Total visits in 2013: 2,688,420 (+41% on 2012)
– Total unique visitors in 2013: 1,707,198 (+44%)
– Average time on site = 1.43 minutes
 Annual extract and distribution

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Requirements for Medical Reps (ctd)
 Treat HCP’s time with respect: i.e. ensure
frequency, timing and duration of calls and the manner
in which they are made are acceptable. Call
cancellations need to have the longest possible notice
(Clause 12.7)
 Take adequate precautions to ensure the security of
medicinal products in their possession (Clause 12.8)
 Not use the phone to promote medicines without prior
arrangement (Clause 12.9)

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Samples
Clause 13.3
I. Samples provided on an exceptional basis only & for purpose of acquiring
experience in dealing with such a product.
II. Do not exceed 4 per year and for first 2 years after first requested...
III. Supply in response to a signed and dated request
IV. Adequate system of control and accountability. This system shall also
clearly establish, for each person supplied, the number of samples provided
in application of the provision in Clause 13.3(ii)
V. Smallest presentation on the market
VI. Marked “Free medical sample – not for sale” or similar
VII.Accompanied by a copy of SmPC (except if in www.medicines.ie and
‘give/make available’)
Cannot sample controlled drugs, anti-depressant, hypnotics, sedatives or
tranquillisers (Clause 13.4)
HPRA guidance: keep sample documentation >1 yr after batch expiry

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Gifts (Clause 14)
 From 01.07.14
– Total ban on gifts

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Grants & other forms of support
(Clause 15)
The following forms of support are permitted:
− Educational grant
− Research grant
− Employment grant
− Donation
− Sponsorship of equipment for the betterment of
patients

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Criteria for Support (Clause 15.2)
 Written request from a HCP or institution
 Grants must be paid directly to an institution rather
than to an individual HCP
 Support provided by a company must be relevant to
the practice of medicine or pharmacy
 Support not linked to any product promotion
 Support must be reasonable (3rd
party test)

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Hospitality and Meetings – General
Principles (Clause 16.1)
 Meetings directly related to bona fide continuing
education of HCPs
 Support must leave professions’ independence of
judgement manifestly unimpaired
 Sponsorship appropriate for a cause related to the
pursuit of medical or pharmaceutical knowledge
 Any hospitality provided must:
- be reasonable in level (3rd
party test)
- be secondary to the main purpose of the meeting
- not extend beyond HCPs

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Hospitality and Meetings (2/4)
Where appropriate and depending on the time,
location and length of the meeting company may
cover (Clause 16.2):
− Actual travel expenses
− Meals
− Refreshments
− Accommodation
− Registration fees

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Hospitality and Meetings (3/4)
The meeting venue needs to meet the following
requirements (Clause 16.3)
− It should be the programme that attracts delegates
and not the associated venue or hospitality
− Must not organise meetings to coincide with sporting,
entertainment/other leisure events or activities
− Venues that are renowned for their entertainment or
leisure facilities or are extravagant are not permitted

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Hospitality and Meetings (4/4)
Other requirements:
 Funding HCPs to compensate for time
spent in attending an event is not
permitted (Clause 16.5)
 All promotional, scientific / professional
meetings etc must be held at an
appropriate venue that is conducive to
the main purpose of the event (Clause
16.6)

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Monetary Threshold for meals & drinks
(Clause 16.3)
 €80 (including VAT, excluding tip)
 Additional to existing restrictions (e.g. reasonable,
secondary to main purpose etc)
 Per meal and per person
 Not to be added to Annex V template (HCP ToV
disclosure template) as already transparent
 Only applies to events in Ireland
 In another EFPIA MS the threshold in that MS applies

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Sponsorship of HCPs’ Meetings
No one company should sponsor series of meetings
to exclusion of other willing sponsors
Smaller (e.g. local clinical) meeting (Clause 16.8):
Companies must respond only to formal written requests for
support which indicate exactly what items are to be sponsored
Support must not extend beyond:
- Room & equipment hire
- Speaker’s travel expenses & honorarium
- Modest meals and/or light refreshments
Larger meetings (e.g. annual meetings):
Rental of exhibition stand acceptable; may exhibit company’s
product range but do not bring products to the meeting or supply
samples at the stand.
May provide a contribution towards general expenses of the
meeting; acknowledged in the list of sponsors

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Corporate Hospitality
 No promotion allowed (direct or implied; no
advertising of Rx products to the public)
 Need for moderation (reasonable: scale & cost): 3rd
party test
 Such hospitality involving sporting, entertainment
or social events must not be extended to HCPs
except as outlined under the charity exception

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Corporate Hospitality:
Charity Exception (Clause 16.9)
 “…on an occasional basis, corporate hospitality
involving events organised by not for profit
organisations and/or a bona fide registered charity
may be extended to HCPs”
 “provided that the clear and transparent objective of
the event or activity itself, is to raise funds for
charitable/benevolent purposes.”
 “Such events must not involve or be in any way
associated with major sporting or social events”.

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Use of HCPs as Consultants (Clause 17)
 Purpose: services (e.g. chairing meetings),
training, participating in advisory boards, market
research
 Conditions:
- Define a legitimate need
- Written contract or agreement with payment details needs to
be signed
- Record needs to be kept
- Not an inducement to prescribe medicinal products
- Compensation must be fair and reasonable
Consultants are encouraged to disclose such arrangements in
their public engagements.

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Market Research, Post Marketing
Surveillance (Clause 18)
General Principles:
 Promotion must not be disguised as market research
(Clause 18.4)
 Do not gain access by subterfuge (Clause 18.2)
 Provisions apply to post-marketing surveillance i.e.
never promotional and must be conducted primarily
with a scientific or educational purpose (Clause 18.5)

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Non-Interventional Studies (Clause 19)
Definition: study of authorised medicines “prescribed in the
usual manner” where “the assignment of a particular
therapeutic strategy is not decided in advance by a trial
protocol but falls within current practice.”
Requirements:
- Specific purpose and written study plan
- Written contract
- Remuneration must be at market rate
- Not an inducement to prescribe
- Scientific Service must approve the study protocol and
supervise its conduct

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Relations with the General Public
(Clause 20) – General Principles
 Prescription-only medicines may not be advertised
to the public (Clause 20.1)
 Information about scientific discovery of a medicine
only to be supplied if necessary or desirable to do so
in public interest or to keep public informed of
scientific/ medical progress (Clause 20.3)
 Disclosure to shareholders or persons with other valid
interest may be required or desirable (Clause 20.3)

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Requirements Concerning Information
to be Released to the Public (Clause 20)
 Be balanced to avoid raising unfounded hopes
 Not be released to public before the medical profession
is informed (Clause 20.5) (exception Clause 20.3)
 Not cover information and advice on personal medical
matters as these need to be dealt with by HCPs (Clause
20.2). This does not however obviate the regulatory
obligation of the MAH to collect appropriate and
comprehensive info from patients (with their consent) to
support meaningful ADR reports as per the legislation.

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Version 8.1 – Recap of Code
Changes
 New clause on patient support items to HCPs
 HCO definition clarified
 ToV disclosure on company website/central platform
Version 8.0 of the Code only required public disclosure of
ToVs, it did not specify location /format. Version 8.1
requires it to be placed on a company website or central
platform.
 EFPIA template mandatory for disclosure of ToV

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Edition 8.1 Code Master Class
Annex I: Code of Practice
Complaints Procedure

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 Anyone can complain
 Respondent has 10 days to reply to IPHA
 Complainant may remain anonymous
 Code Council meeting within 30 days
 Decision 10 days after
 Only respondent can appeal
 Sanctions vary
General Principles

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Edition 8.1 Code Master Class
Annex II: Guideline on Nursing Services
Provided by Pharmaceutical Companies

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Context & Purpose of Guidance
 Companies provide services of specially trained nurses to
educate patients about the medicines they take.
 The nurses may be employed by the pharmaceutical company
or contracted by 3rd
party agency.
 Seeks to ensure standards of best practice in the operation of
these services.
 Enhance the understanding of the role and authority of such
nurses in the provision of these services.

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Statement of Best Practice 1
1. No promotion
The provision of nursing services must be done in such a
way as to avoid any inference that they might be
considered to be an inducement designed to promote the
prescription, supply, sale or consumption of a medicine.
2. No prescribing by nurse
Decision on what medicine to prescribe rests with person
prescribing. The nurse has no authority to prescribe or to
change a prescription in this context.

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Statement of Best Practice 2
3. Advice about medicinal products to patients
Nurses may provide direct advice to a patient about a
medication upon receipt by the patient of a prescription.
The advice must be consistent with PA.
4. Services by prior arrangement only
Companies should only offer the services of nurses in a
doctor’s clinic by prior arrangement.

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Statement of Best Practice 3
5. Role of nurse
Nurses must operate to detailed written instructions provided
by the company which should clearly set out their role.
Nurses must by mindful of their professional nursing role and
of the need to maintain registration with the Nursing and
Midwifery Board. The Board’s Code of Professional Conduct
states that registration status should not be used in the
promotion of commercial products.
Important not to confuse the nurse’s role with that of a
medical representative.

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Statement of Best Practice 4
6. Written protocol for doctor
Written protocol to be provided by the company to the medical
professional in the practice/clinic which is receiving the nursing
service to avoid any misunderstanding as to what he/she has
agreed.
7. Nurse remuneration
Remuneration of nurse must not be linked to sales in any territory
or place or to sales of a specific product or products and may not
include a bonus linked to such sales.
Bonus schemes linked to a company’s overall national
performance or to the level of service provided, may be
considered.

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Statement of Best Practice 5
8. Printed material for patients
Printed patient oriented material provided by the nurse to the
patient must:
− be non promotional;
− not promote the prescription, supply, sale or consumption
of the company’s products;
− identify the pharmaceutical company involved.
9. Patient confidentiality
Patient confidentiality is crucially important
– Any details taken and retained by the nurse should be agreed
with the health professional and patient;
– Comply with current data protection legislation.

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Statement of Best Practice 6
10. Training of nurses by employer
Companies must ensure that nurses are adequately trained
for the role that they will undertake. In particular, they must
be familiar with:
– the products of the company in relation to which the
services are provided;
– this Statement of Best Practice.
11. Code of Practice
Nurses must be fully conversant and compliant with the
Code of Practice.

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Statement of Best Practice 7
12. Adverse reaction reports
Nurses should transmit to their companies any adverse
reactions reported to them.
13. Companies responsible for nurses
Companies are fully responsible for the activities of the
nurses (including those contracted from a third party) within
the scope of their employ/contract.
14. Patient right to opt-out
The patient may at all times reserve the right to decline the
support offered by nurses and such decisions must be
respected.

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Edition 8.1 Code Master Class
Annex III: Guideline for Pharmaceutical
Companies on Working with Patient
Associations

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2, General Principles
 Independence of the patient association (PA) must be
guaranteed
 Mutual respect and trust applies
 Public disclosure of direct and indirect support is required
 No link with product promotion
 Mutual provision of background information on the project needs
to be made available upon request
 Permission required for public use of PA’s logo by a MAH

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3, Funding Patient Associations
There are a number of ways to fund
 Core funding
 Funding for publication, meeting, project, research etc
for which company has little or no involvement
 Facilitation of association meetings by sponsoring
speakers, venue or contributing to travel expenses
 Undertaking of projects of joint interest

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Editorial Control
The independence of the PA must
be guaranteed...
pharmaceutical companies must
not seek to influence the text of PA
materials they sponsor in a manner
favourable to their own commercial
interests...
However...
at the request of PAs, companies
may contribute to the drafting of the
text from a fair and balanced
scientific perspective.

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Transparency
 Partnership programmes & funding arrangements proper & seen
to be so
 Each MAH make ‘publicly available’ a list of PAs who received
financial support and/or significant indirect/non-financial support
include description of the nature of the support that is
sufficiently complete to enable the average reader to form
an understanding of the significance of the support...
include monetary value of financial support and of invoiced
costs.
 For significant non-financial support that cannot be assigned a
meaningful monetary value the description must describe clearly
the non-monetary benefit that the PA receives

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Transparency explained
 Not reasonable to expect companies to list insignificant
items (e.g. coffee at spontaneous meeting).
 Although non-monetary support not invoiced cannot be
allocated an accurate financial value, such support
perceived to be ~€250/ activity should be included.
 Info may be provided on national / European level
 List updated at least annually by Q1 of next year

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Contracted Services
 Where MAH contracts services from a PA must have
written contract, legitimate need, record maintenance
and reasonable service compensation etc...
 MAH must make public
– list of PAs engaged to provide significant contracted services
with a description of the nature of the services sufficient to
enable understanding
– total amount paid per PA over the reporting period

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Funding Patient Associations
Funding principles:
 Recognition of the limit of pharma’s involvement
 No one company should fund a project to the exclusion of
other available and willing sponsors
 PAs retain independent control of their project
 Hospitality only extended to those who qualify in their own
right and a bone fide ‘carer’ of a participant if the participant
has clear health needs (e.g. disability).

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Edition 8.1 Code Master Class
Annex IV: Guideline on Digital
Communication in the
Pharmaceutical Sector

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Scope
 Digital communication / marketing aimed at HCPs here
– social networking sites
– content communities
– blogs & microblogs
– user forums & digital platforms developed with users
– wikipedia, digital games
– emails, SMSs etc
 Incl internet outside Ireland, placed / authorised by Irish
company making reference to use / availability in Ireland
 Rx medicines only
 This guidance is a compliment to the IPHA Code
 Effective Jan 2014

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1.1 General Rules
For company owned/controlled digital platforms
 Must provide
– Information source
– publication date
– description of entities from which information obtained
 Homepage mandatory & must link to following information
– Identity of digital platform owner (company logo, street
address, e-mail address, phone number)
– Purpose & target audience(s)
 Information must be reviewed & authorised (dates)

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1.1 General Rules ctd
 No Rx medicine promotion on landing page
 ADR, complaint and content monitoring procedures
 Reasonable care when referencing (linking)
– Code compliance in introducing links
– Clear to visitor whether company sponsored /independent platform
– Clear to visitor if leaving platform owned/funded by company
– Avoid linking to dynamic content (Code adherence difficult)
 Data privacy legislation for email databases
 Unsubscribe facility & appropriate archiving

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1.2 Information aimed at Public
For company controlled/sponsored digital platforms
 No Rx medicine promotion
 Mandatory statement on landing page (& possibly other)
– “ Information placed on this digital platform is not intended as a
substitute for consultation with your HCP” or similar
 Statement for consideration
– “Please consult your HCP for further information’’

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1.3 Information aimed at HCPs
For company controlled/sponsored digital platforms
 Process preventing access of others at entry point
 If platform has information for both HCP & public
– Segregate sections & use statement such as ‘this section is
intended for HCPs only’ or similar
 If platform enables exchange of views by medics
– Should have moderation rules in T&C
– Must have procedures to remove offending material & to advise
contributor of issue in the event of breach

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1.3 Information for HCPs ctd
Banners etc
 If insufficient space
– direct visitor to click on Ad to bring to required information or
– Button with ‘Abbreviated Prescribing Information‘ or similar
 Direction / button prominent & clearly legible
 Hyperlink direct from Ad to SmPC, API etc
 SmPC, API etc in prominent & clearly legible format
 Linking to www.medicines.ie is recommended

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Other
• Company policy regarding social media use by employees
recommended (1.4)
• email addresses confidential & Data Protection rules (1.5)
• Mechanisms to prevent unwanted / abusive messages (1.6)
• If content not controllable - right to remove material in rules (1.6)
• ‘Share’ ‘Like’ or similar only in circulars to public if no Rx medicine
related content (1.6)

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Third Party Platforms / Q&As
Third Party Digital Platforms (1.7)
• Funded by companies through sponsorship, grant etc
• Written contract outlining obligations including
– PhV responsibilities (if relevant)
– control of digital platform content to ensure Code compliance
• For platforms aimed at the public
– measures taken to ensure no Rx medicine promotion (e.g.
wording in agreement)
Questions and Answers (3.0)

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Edition 8.1 Code Master Class
Annex V: IPHA HCP / HCO
Disclosure Code

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Disclosure Obligation
 MAH must document & publicly disclose all
ToVs
– direct or indirect
– OTC, items of med utility, meals, samples or
items that are part of ordinary course of sale &
purchase excluded
– If OTC medicines available Rx (e.g.
reimbursement condition) then ToVs related to
these OTCs are disclosed
– http://www.youtube.com/watch?v=Me6LzUR_68U

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Disclosure Obligation
 MAHs proactive in seeking consent from HCPs & HCOs
 Annual disclosure cycle starting in 2016 for 2015 data
 Disclosure in country where HCP has physical address
 Publish within 6 months of year end

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Disclosure Obligation ctd
 Information to remain public for 3 yr
 Records kept for >5 yr after end of reporting period
 Recommend consent in new (& check existing) contracts
 Non duplication (disclose only once)
 Company must publish summary note of methodology

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Categories for ToV to HCO
 Donations and Grants
 Contribution to cost of events
– Registration fees
– Sponsorship agreements
– Travel and Accommodation
 Fees for Service and Consultancy
– Fees
– Related expenses detailed in the contract

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Categories for ToV to HCP
 Contribution to costs of events
– Registration fees
– Travel and Accommodation
 Fees for Service & Consultancy
– Fees
– Related expenses in the contract

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Individual & Aggregate Disclosure
 The aim is for disclosure on an individual basis
 Category-by-category aggregation for an individual is
acceptable if itemised data shall be made available
upon request to authorities and/or recipient
 Aggregation permissible if
– Valid legal reason why cannot disclose individually
– Related to Research and Development
a. Non-clinical studies (as defined in OECD Principles of GLP)
b. Clinical trials (as defined in Dir 2001/20/EC)
c. prospective non-interventional studies involving patient data collection
from ,or on behalf of, HCPs specifically for the study

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HCP Disclosure – where are we?
 Formal part of Annex to the IPHA Code
 Meetings & discussions with HCOs in 2013, ’14 & ‘15
 Roundtable HCO meetings
 Final disclosure template from EFPIA
 Member communication pack available
 Message to HCPs: disclosure will not occur without prior
HCP consent & knowledge

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Medical organisation perspective
 Generally positive
− e.g. RCPI
• if support is received from the Pharma Industry, the
company should be a member of IPHA
• In public presentations, journal articles and
equivalent, individual trainees, members and fellows
must declare potential conflicts of interest and any
industry funding received
• Section describing IPHAs ToV Disclosure initiative
REF: RCPI Guidance on Industry Sponsorship and Support, Feb 2015

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Useful Websites (1)
 www.ipha.ie
 www.medicines.ie
Up-to-date SmPCs and Package Leaflets for products available in Ireland
 Irish Statute Book online www.irishstatutebook.ie
 Health Products Regulatory Authority www.hpra.ie
 Department of Health www.doh.ie

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THANK-YOU!