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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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Status2015

50 YEARS OF PHARMACEUTICAL LEGISLATION50 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 pharmaceuticalsNow: 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 millionEmployment less than 2,000Employment less than 2,000

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Exports less that €100 millionExports less that €100 millionEmployment 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 LegislationEU 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 CodesTwo 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 CodeAddition of new clause that clarifies existing practices regarding the provision of patient support items to HCPs  (Clause 4.9)

Annex VHCO Definition clarified Section 1 of Annex V

ToV disclosure on company website/central platformVersion 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 ifInexpensiveDirectly relevant to practice of medicine/pharmacyDirectly beneficial to patient care

Pens/paper at company organised meetings if No product brandingInexpensive

Other meetingsNo pen/paper distribution at exhibition standsNo 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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SamplesClause 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 sponsoredSupport 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 platformVersion 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 promotionThe 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 nurseDecision 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 patientsNurses 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 onlyCompanies 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 46. 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 remunerationRemuneration 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 58. 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 confidentialityPatient 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 employerCompanies 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 PracticeNurses must be fully conversant and compliant with the Code of Practice.

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Statement of Best Practice 712. Adverse reaction reports

Nurses should transmit to their companies any adverse reactions reported to them.

13. Companies responsible for nursesCompanies 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-outThe 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 ControlThe 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 AssociationsFunding 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 RulesFor 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 PublicFor 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&AsThird 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.ieUp-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!