The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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The National Code of Ethics in Hungary How to turn the Code into the practice?

Rita Fülöp M.D.Head of Regional Diabetes Division Sanofi

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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Pharmaceutical promotion has a unique position

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„Pharmaceutical promotion influences the prescribing behavior of health professionals. The pharmaceutical industry differs from other industries in that its products directly affect the health of patients. International bodies, the pharmaceutical industry and various national professional or industrial organizations have voluntarily been developing and implementing codes of practice for the promotion of medicines. These have generally been based on the Ethical Criteria for Medicinal Drug Promotion.” WHO 1988.

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Ethical aspects of promotion●

ensures that healthcare professionals have access to the information they need;

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that patients have access to the medicines they need, ●

and medicines are prescribed and used in a manner that provides the maximum healthcare benefit to them.

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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The increasing healthcare costs have influence even on promotional activities

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Pharmaceutical companies are facing with●

The tendency of governments to hand over responsibility for the control of pharmaceutical promotion

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ongoing criticism on the self-regulation of pharmaceutical promotion;●

challenge on the profit levels in pharmaceutical industry, ●

impact of intensive marketing activities to influence prescribing behavior, and the health risks because rational use of medicines is jeopardized;

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The strategic goal of pharmaceutical industry: short and mid term goals●

To shift the government’s mindset • Healthcare is not a financial burden• Healthy population is major driving force of the economy

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How to reach it: the industry wants to be seen as a professional partner of the Government

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We intend to develop robust standards and to ensure compliance with the highest level of ethics, integrity and transparency to regain the trust of our stakeholders

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The continual code revisions are tools for the industry to implement best practices in the control of pharmaceutical promotion.

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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Message of Eduardo Pisani General Director of IFPMA

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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The key changes in the Code are harmonized with the IFPMA code

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Beyond promotional practices cover all interactions with healthcare professionals, medical institutions and patient organizations

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Provide new high level guiding principles for ethical conduct and promotion of pharmaceutical products and services

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Include a provision on disclosure of clinical trials information

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Require Code training for all relevant employees of member companies appropriate to their role

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Make a clear distinction between gifts, promotional items, and items in connection with medical practice

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Set forth guidance for management of complaints

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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History of self-regulation in Hungary

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The Communication Ethical Committee was established in 1994 ●

with 9 MAGYOSZ members●

focus on both RX and OTC products and additionally on paramedicines and veterinary products

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Common Ethical Committee with AIPM since 1996 ●

4-4 members from the associations●

Yearly changing president delegated by the associations●

Since 1998 – working only with Rx and OTC drug promotion●

Since 1st of March, 2012●

All the 4 associations signed the Code (AIPM, MAGYOSZ, Vaccines, Gx)●

The president of the committee will be independent from the pharmaceutical industry

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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Most common cases, what the Ethical Committee faced

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Travelling / congress participation organized for Health Care practitioners

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Free drug samples for clinicians

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Entertainments during scientific symposia

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Advertisement, with unbalanced promotional messages

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Promotion on medical websites with exaggerated messages

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Off label messages for Rx products

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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Timing and Scope

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Code of Practice on the promotion of prescription-only medicines to, and interactions with, healthcare professionals (HCP Code)●

Rx only●

14.06.2011

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EFPIA Code of Practice on relationships between the pharmaceutical industry and patient organisations●

14.06.2011

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Hungarian National Code - CODE OF ETHICS FOR PHARMACEUTICAL MARKETING COMMUNICATIONS●

4 associations (AIPM, MAGYOSZ, Vaccines, Gx)●

01/03/2012●

Amended - All mandatory EFPIA code changes included – HCP & Patient Code●

Changes of legal environment acknowledged

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IFPMA Code of Practice●

01/09/2012

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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The way of implementation and the high engagement level is key to reach success

Spirit of the Code●

It must be emphasized that best practice in the self-regulatory system of drug promotion depends not only on the letter of the code but also on the spirit underlying the code.

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All recommendations for code requirements and enforcement mechanisms can only lead to an effective and empowered self-regulatory system if the genuine objective of pharmaceutical promotion is to improve the rational use of drugs.

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For both health-care professionals and the pharmaceutical industry, the rational use of medicines and enhancement of patient care should have priority.

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Prescribing decisions should be evidence-based, instead of marketing- based.

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Therefore, the industrial spirit underlying these codes is of great relevance and should be focused on the rational use of drugs, in order to maintain professionalism and to ensure the position of the industry.

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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From advertisements towards social media the world of Internet creates new challenges for regulation

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The patients’ need for detailed medical information is getting higher – they want to play active role in their treatment and medication

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The „word of mouth” power competes with the Health Care Practitioners explanations

First step toward efficiency

Is Your Doc Social?

„FDA issues social media rules for pharma”

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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Unregulated activities – areas for development

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Pharmaceutical key activities in the past:●

Advertisements●

Clinical studies●

Publication of the scientific results●

Education programs●

Congress activities

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New fields of communication●

Patient education●

Patient support programs●

Use of Internet and web/based solutions to share information• Limited access for HCPs and / or• Limited information to patients?

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Authorities – outcome based financing system: active involvement of patients to have better therapeutic result would need the introduction of patient programs ●

How to inform patients improving their health care status keeping the standard?●

Does it mean responsibility or only opportunity for the pharma companies?

Information towards HCPs- as it is in their main interest

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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Pharmaceutical companies start activities on the Internet Health Care sites for patients are open for cooperation

The Sixth International Pharmaceutical Compliance Congress and Best Practices Forum

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Pharmaceutical companies are intend to become a 360°partner: delivering drugs with integrated healthcare solutions and also a support in disease management for the patients

PATIENTPATIENTPATIENT

NEEDSNEEDSNEEDSSupport in lifestyle changes

Dedicated & Equipped centres with all necessary

HCPs

Personalised programs

closed to home

SERVICESSERVICESSERVICES Disease management

programs

Medication

Patient education program with patient associations, HCPs

Education on disease and

complications

Special centers

Patient education programs / materials

Treatment / devices