version 2 - sfda · 2018. 5. 2. · kingdom of saudi arabia). symposium or conference sponsorships...

Version 2.1

Date of publication 6 June 2016

Date of implementation To be announced

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Transparency and Payments

Disclosure Guidance for Medical

Companies

Version 2.1

Please visit SFDA’s website at for the latest update

Comments to Drug Sector [email protected]

Comments to Medical Device

Sector

[email protected]

mailto:[email protected]

mailto:[email protected]

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Saudi Food and Drug Authority

Vision and Mission

Vision

To be the leading regional regulatory authority for food, drugs and medical devices with

professional and excellent services that contributes to the protection and advancement of the

health in Saudi Arabia.

Mission

To ensure the safety of food; the safety, quality and efficacy of drugs; and the safety and

effectiveness of medical devices, by developing and enforcing an appropriate regulatory system

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Document Control

Version Author Date Comments

1.0 Drug sector 6 June 2016 Draft

2.0 SFDA 5 February 2018 Final version

2.1 SFDA 29 April 2018 Update the implementation date

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Table of Contents

I. Introduction .......................................................................................... 6

II. Glossary and Abbreviations ................................................................. 7

III. Objectives of the Disclosure Initiative ................................................. 8

IV. Nature of Payments .............................................................................. 8

V. Information Companies Will Be Required to Provide ....................... 11

VI. Reporting Time Line and Format ....................................................... 12

VII. Appendices: ........................................................................................ 13

Appendix1: Companies Disclosure (HCP) ............................................... 13

Appendix2: Companies Disclosure (HCI) ................................................ 15

Appendix3: HCP Disclosure ..................................................................... 16

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I. Introduction

The relationship between medical companies supplying medicines and medical

devices on the one hand, and health care professionals (HCPs) and health care institutions

(HCIs) on the other hand is important and has a clear impact on the availability of medical

products proper to the needs of patients and beneficiaries. This relationship is also useful

in the exchange of medical and technical information regarding the quality, safety medical

products and their safety using. These relationships can benefit patients by providing

researchers with funds for drug development and clinical research or scientific research

and evaluating the efficacy or safety of medical devices, sharing ideas for best clinical

practices, and exchanging information on how new drugs can improve patients’ conditions.

Generally, medical companies like a pharmaceutical companies and medical devices

companies provide financial support related to HCPs and HCIs. These financial

relationships include payments for consulting, sponsorships for conferences or speaking

engagements, pay for travel, donations for research, and others either direct or indirect.

Consumer advocates, therefore, have long been concerned about the conflicts of interest

and demanded transparency in these relationships.

Because of the interest in making such relationships transparent, a number of countries

have begun initiatives to this end. To ensure continued public trust, many countries have

developed specific laws to bring transparency to the financial relationships among

pharmaceutical companies, HCPs, and HCIs to ensure that the trust of society maintained.

Greater transparency in HCP, HCI, and medical Companies interactions can positively

help all parties adhere to the fundamentals of collaboration. Therefore, if a transparency

report discloses Companies payments with accuracy and clarity, it can discourage

Unethical financial relationships and help control conflicts of interest while promoting

positive relationships.

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II. Glossary and Abbreviations

Medical companies: includes Commercial Institutions that owner of one or more of

the company engaged in the manufacture, marketing, or distribution of

pharmaceutical products or medical devices or the like, such as pharmaceutical

companies and medical devices companies and have licensed to operate according

to existing regulations in the Kingdom of Saudi Arabia.

Health care professional (HCP): is any person licensed to practice a health care

profession in the Kingdom of Saudi Arabia. Including individuals and committees

involved in making technical evaluation decisions and purchasing pharmaceuticals

products, medical devices and medical products.

Health care institution (HCI): is a public or private health care facility that provides

health care services, including hospitals, primary health care centers, general

medical complexes, specialized medical complexes, clinics, radiology centers,

medical laboratories, one-day surgery centers, health care service support centers,

and ambulance transport service centers.

Conflict of interest: is a contradiction between the professional or personal interests

and needs of an HCP and his or her professional responsibilities toward a patient.

Transparency report: The report submitted by medical companies discloses the

names of HCPs and HCIs that have received payments or other transfers of value

from them and the reasons for providing such financial support along with the total

amounts of payments or value transferred by type of activity.

Beneficiary Third party is a person or organization other than the pharmaceutical

company and medical devices (first party) or HCP (second party) involved in the

financial relationship.

Pharmacy and therapeutic (P&T) committee is a standing medical committee of

HCPs in hospitals located in Saudi Arabia. The committee is composed chiefly of

physicians, pharmacists, and nurses with broad representation from physician

specialty groups in the hospital. The committee recommends the adoption or assists

in the formulation of policies regarding evaluation, selection, and safe and

therapeutic use of drugs in the hospital.

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III. Objectives of the Disclosure Initiative The main objective of this initiative is to improve transparency of financial relationships

among medical companies, HCPs, and HCIs. Such transparency will help achieve the

following:

1. Organizing and clarifying financial relationships between medical companies,

HCPs and HCIs, and limiting any potential of illegal or unethical relationships.

2. Improving transparency of research funding (Increase transparency in all health-

related procedures)

3. Protect the patient rights and beneficiaries by ensuring the integrity of medical

decisions based on scientific and professional basis.

4. Minimizing potential conflicts of interest for regulatory related decisions

5. Documentation of direct and indirect financial support data provided by medical

companies.

IV. Nature of Payments

Medical companies must report to Saudi Food And Drug Authority (SFDA) all

financial supports including, but not limited to, the following activities:

1. Consulting fees

2. Speaking fees

3. Training fees

4. Sponsorship of HCPs to attend an educational event

5. Research or educational grants (restricted or unrestricted)

6. Symposium or conference sponsorships

7. Hospitality

8. Gifts or entertainment

9. Supplying scientific materials (e.g., books or instruments).

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Nature of

payments Definition

Consulting Fees

Fees paid to HCPs for professional advice and expertise on a specific medicinal

product, usually provided under a written agreement.

Example:

- Payments made to a physician for advice on how to design a study to evaluate

the efficacy of a newly developed drug or Study and evaluation of the

efficiency of medical devices and products —the physician is paid on an

hourly basis for his or her advice, and travel and accommodations are

provided.

- Fees paid to HCPs in their roles as advisory board members, such as sitting

fees, accommodations, and travel.

Speaking Fees

Payments made to an HCP for serving as a speaker at an event or provide a lecture or

introductory/teaching presentation about a disease or medical technique

Example:

- A medical company fund a practitioner to present his experience on dealing

with a medical device inside or outside the hospital or publishing an article

about the device.

Sponsorship of

Travel and

Accommodation

and/or

Registration

Fees

Payments made to HCPs for attending an educational event/ conference/ Specialized

exhibition that involves acquiring specific knowledge or skills.

Example:

A medical company sponsoring an HCP to attend a symposium or conference on a

particular medical subject—the pharmaceutical company pays for travel,

accommodations, and/or registration fees (whether held within or outside the

Kingdom of Saudi Arabia).

Symposium or

Conference

Sponsorships

Payments made to HCIs or scientific societies for organizing a symposium or

conference.

Example:

- A medical company sponsoring a conference on a particular medical

condition at a teaching hospital in Saudi Arabia.

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Research and

Educational

Grants

Research grant: funding for activities related to research.

Example:

- A medical company providing funds for coordinating and implementing a

research study or payments for enrolling participants to cover expenses in

relation to the study.

Educational grant: funds provided to HCPs or HCIs as support for a special course

or performing a specific activity.

Example:

- A medical company providing a grant to a physician in support of special

training or a course that provides updates on a disease’s treatment by covering

part of the cost.

Restricted grants: funds given for specific purposes.

Unrestricted grants: funds that could be used for any purposes.

Hospitality

(Food and

Beverages)

Any payments made to HCPs or HCIs for meals and hospitality or guarantee cost of

hospitality that exceeds the specified financial standards like the defined limit set by

the Saudi Code of Pharmaceutical Promotional Practices (SR 50) Or any cost

approved by related parties.

Gifts or

Entertainment

Any payments made to HCPs or HCIs for gifts or entertainment that are above the

specified financial standards like the defined limit set by the Saudi Code of

Pharmaceutical Promotional Practices (SR 50) or Any financial limit approved by the

relevant authorities

Gifts: promotional items (e.g., pens, prescription pads, clocks, flash memory, etc.) or

anything provided to HCPs or HCIs that does not fit into another category.

Entertainment: Ensuring fees and attendance expenses that exceed the cost of

specific financial standards.

Example:

- Pharmaceutical companies should not report any payments or transfers of

value that are less than SR 50 per payment unless the total aggregate amount

exceeds SR 500 per calendar year.

Scientific

Materials

Supplying scientific materials to HCPs that involve acquiring particular scientific or

medical knowledge or skills.

Example: Textbooks, journal articles, or research instruments.

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V. Information Companies Will Be Required to Provide

Payments to HCPs require the following information:

HCP title (i.e., physician, pharmacist, nurse, and relevant decision makers such as

professionals participating on the pharmacy and therapeutic [P&T] committee or

planning and Tender committee members and technical evaluation of medical

devices and products)

Full name of the HCP (first and last name)

Specialty

National ID / Iqama no.

Saudi professional registration ID

Principal practice address of HCP

City and region

Contact e-mail

Payments to HCIs require the following information:

Name of institution

Department(s) where the payment will be utilized

Payment recipient (section/department)

City and region

Address line

Postal code

Contact e-mail

Payment details must include the following:

Date of support and expenses

City and country of the event

Nature of the payments

Purpose of the payments (e.g., advertising, education, fees for consultancy,

donations, grants, fees for services, and travel and accommodation)

If the payment was made to a third party:

The amount of each payment or transfer of value

The aggregate amount of payments per calendar year (yearly amount)

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VI. Reporting Time Line and Format Saudi Food & Drug Authority (SFDA) will provide an electronic form for

disclosure as well as a time line for submission of the required data.

Medical companies and HCPs will enter the required disclosure data in the

electronic form

It is the responsibility of Medical companies to document, complete, and submit

the disclosure data to SFDA according to the SFDA approved time period (Annual

/ monthly)

Before to publication of disclosure data, a medical companies and HCPs are given

a time limit for matching and auditing the data entered.

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VII. Appendices:

Appendix1: Companies Disclosure (HCP)

This form is submitted by medical companies when providing financial

support to HCP

Submission no.

Company/ institution name

Data entry name

Submission date / /

HCP

Title

First name

Family name

Specialty


National ID / Iqama no.

Email

Mobile no.

Payments details

Type Gift (not cash) Financial (cash)

Total amount (in case of gift, please mention the total cost)

Purpose of the payments

Research Training Conference Product Promotion Product Presentation Gift Other

Receiving data

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Third party (If any)

HCI name

HCI code

Department that utilized payment (optionally)

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Appendix2: Companies Disclosure (HCI)

This form is submitted by medical companies when providing financial

support to HCI

Submission no.

Company/ institution name

Data entry name

Submission date / /

HCI

Institution name (hospital) / Association

Region name

City name

Department that utilized payment (optionally)

Payments details





Receiving date

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Appendix3: HCP Disclosure

This form is submitted by HCP when receiving financial support from

medical company

HCP - Beneficiaries

Submission no.

Data entry name


National ID/ Iqama no.

Payments details





Receiving date

In case of it from company:

Name of the funded / supporting company

Company Commercial Register No.

In case of it from HCI:

HCI name

HCI code

HCI telephone no.

Date of payment received HCI name

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