Ethical Relation Between Doctors and Pharmaceutical

Industry !!!

Dr. Md. Shahinul AlamAssociate Professor of Hepatology

Bangabandhu Sheikh Mujib Medical UniversityDhaka. Bangladesh

Component of presentation

1. History and background2. Current status in the world3. What is going on in Bangladesh ?4. What should be our standard

recommendations for Bangladesh ?

History and Background

Prehistoric Medication (30,000 BC)

Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first soothing application.

Ancient Babylonia (about 2600 B.C.)

Practitioners of healing of this era were priest, pharmacist and physician, all in one. Ancient Babylonian methods find counterpart in today's modern pharmaceutical, medical, and spiritual care of the sick.

Medicine in Ancient China (2000 BC)

Chinese Pharmacy, according to legend, stems from Shen Nung. He reputed to have tested many of them on himself, and to have written the first Pen T-Sao, or native herbal, recording 365 drugs.

Egyptian Medicine (1500 BC)

Though Egyptian medicine dates from about 2900 B.C., best known and most important pharmaceutical record is the "Papyrus Ebers" (1500 B.C.), a collection of 800 prescriptions, mentioning 700 drugs.

Greece Medicine ( About 300 BC)

• Most medicines were prepared from plants.

• Physicians took care of the pharmaceutical part of treatment and they were responsible for the drug being prepared properly and for the administration of the drug.

• Were groups of drug preparers and sellers which some physicians used.

Theophrastus the greatest early Greek philosophers and natural scientists, is called the "father of botany

Pharmacy in Greece: Hippocrates

• Father of Medicine• Developed the concept of

the “ four humors”.• Blood, phlegm, yellow bile

and black bile.• Believed that illness was a

result of an imbalance of the humors.

Pharmacy in Greece: Dioscorides

• Traveled with Roman soldiers and recorded his observations.

• Developed the first encyclopedia of drugs, Materia Medica– A systematic way of

describing the drugs, their effects and how they should be stored.

Monastic Pharmacy

During the Middle Ages remnants of the Western knowledge of Pharmacy and Medicine were preserved in the monasteries (fifth to twelfth centuries).

The First Apothecary Shops in Baghdad in 754

The Arabs separated the arts of apothecary and physician, establishing in Bagdad late in the eighth century the first privately owned drug stores.

Avicenna – The “Persian Galen”

Among the brilliant contributors to the sciences of Pharmacy and Medicine during the Arabian era was one genius who seems to stand for his time - the Persian, Ibn Sina (about 980-1037 A.D.),

Separation of Pharmacy and Medicine (17th Century)

In areas where Arabic culture interacted with the West the idea of separation of pharmacy and medicine was passed on.

The First Official Pharmacopeia

The idea of a pharmacopoeia with official status, to be followed by all apothecaries, originated in Florence. The Nuovo Receptario, originally written in Italian, was published and became the legal standard for the city-state in 1498.

American Pharmaceutical Association was founded in 1852

The Great Transformation

1902-1952

The Standardization of Pharmaceuticals Development of Chemotherapy

Pharmaceutical Research The Era of Antibiotics

The Continuing Evolution1952-2002

Pharmaceutical Manufacturing Comes of Age

An advertisement, c. 1885, promoting the medicinal use of a cocaine based product.

The marketing of medication has a long history

Contribution of Pharmaceutical Industries

• Approximately 60 percent of biomedical research• Clinical trials of more than 70 %• Shoulders >50% of the costs of continuing medical education.

Pharma and Doctors

•Financial entanglement has bred close ties between the industry and physicians•Beneficiary of small “educational” gifts such as pens and pads or lunch •Many physicians attend dinners to hear expert talk about a product, take educational trips to resorts, or receive funds (explicitly without strings attached) in the form of research grants, trainee support, or lucrative consulting fees

Physician, Pharma and Patient•These interactions are defended as a way to provide useful information for physicians as they address difficult problems in treating their patients.•But at what point does the influence become corrosive to the good of the patient?•Governance of the relationships between physicians and pharmaceutical companies has long relied on professional concern about potential conflicts of interest, rather than legal regulation.

Anti Kickback Law in USA

•Federal prosecutors applied it in areas in which there was clearly an intent to increase referrals — for example, situations in which one physician kicked back a portion of the Medicare payment for a Holtermonitor to the referring physician.

•Also for drug prescription

Penalties of Pharma an Example

•Federal prosecutors charged TAP and Abott with criminal violations of the Prescription Drug Marketing Act,38 were intended to induce prescriptions for Lupron and therefore constituted kickbacks•TAP entered into a settlement with the government in which it agreed to pay $290 millionin criminal fines plus $585 million in civil penalties.

Penalties continued

On July 14, 2004, Schering-Plough pleaded guilty and paid a fine of $350 million, in part for providing grants to private physicians to conduct educational programs, which prosecutors characterized as kickbacks.

Who should address in Bangladesh?

In 2002 and 2003,• The American Medical Association•American College of Physicians•Accreditation Council for Continuing MedicalEducation•Pharmaceutical Research and Manufacturers of America their own codes of conduct

If Not ………….

prosecutorial activity that is currently focused on

conflicts of interest in the interactions betweenphysicians and pharmaceutical companies

Why not We ?

Current status in the world

At a Glance• The Global Pharmaceutical market is worth

US$300 billion a year

• A figure expected to rise to US$400 billion within three year

• Companies currently spend their one third of all sales revenue on marketing their product.

Pharmaceutical industry Spending on Promotion

17.8

21

15.713.9

12.511

9

0

5

10

15

20

25

1996 1997 1998 1999 2000 2001 2002

Prom

otio

nal e

xpen

ditu

res (

$ bi

llion

s)Promotional spending on prescription drugs, l996-2002

Source: NIHCM, 2001

DTC ads 12.5%$2.63billion

Samples 56.1%$11.78 billion

Detailing to doctors 25.3%$5.3 billion

Journal ads 2%$480 million

Hospital detailing 4.1%$861 million

Promotional spending on prescription drugs, 2002

Total spending: $21 billionSource: IMS Health

2.5

1.85

1.321.07

0.791

0

0.5

1

1.5

2

2.5

3

1996 1997 1998 1999 2000

Prom

otio

nal e

xpen

ditu

res (

$bill

ions

)Direct to consumer advertising on prescription drugs,l996-2000

Source: NIHCM, 2001

Direct to consumer advertising spending in the U.S., 2000

Source: NIHCM, 2001

125

146161

169

0

20

40

60

80

100

120

140

160

180

Pepsi Budweiser Vioxx GM Saturn

Spen

ding

($ m

illio

ns)

Comparison of median revenue dedicated to R&D, profits, and marketing/administration, Fortune 500 drug companies, 2000 (n=11)

Source: Public Citizen, 2001

12%17%

30%

0%

10%

20%

30%

40%

50%

60%

R&D as % of revenue Profits as % ofrevenue

Marketing &administration as %

of revenue

Main task of drug company employees, 2000

Distribution, Other

2%

Production,Quality Control

26%

R&D22%

Marketing39%

Administration11%

Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

Drug company jobs in marketing and research, 1995-2000

55,348

87,810

49,409 48,527

0

20,000

40,000

60,000

80,000

100,000

1995 1996 1997 1998 1999 2000

MarketingResearch

Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

# Jobs

18.7%

11%

5%

0%2%4%6%8%

10%12%14%16%18%20%

Prof

it as

% r

even

ue

drug industry median profit as % revenueother industry median profit as % revenue

Profitability of drug industry, l993-2000

•Source: Public Citizen update of Stephen W. Schondelmeyer calculation, Competition and Pricing Issues in the Pharmaceutical Market, PRIME Institute, University of Minnesota based on data found in Fortune magazine, 1958 to 1999; Fortune magazine, April 2000, Fortune 500 (www.fortune.com).

2.8%

Fortune 500 drug company profitability compared to all other Fortune 500 companies, 2000

Source: Public Citizen, 2001

19% 18%

29%

15.8%

3.9%4.9%

0%5%

10%15%20%25%30%35%40%45%50%

Profits as %of revenues

Profits as %of assets

Profits as %of equity

Drug industrymedian

All Fortune 500industriesmedian

Sources of increased drug expenditures, 2000-2001

Increased number of

RxsShift to more expensive

drugs

Increased cost of drugs

Source: NIHCM, 2002 Total increase: $22.5 billion

24%

39%

37%

At a Glance

• The 10 largest drugs companies control over one-third of this market

• Several with sales of more then US$10 billion a year. And profit margin of 30%

• Six are based in USA & other in Europe

What is going on in Bangladesh ?

Bangladesh

• Here, the pharmaceutical industry developed rapidly from the 1980s after the introduction of Drug (Control) Ordinance-1982.

• Due to recent development of this sector, the country is exporting medicines to global market including European countries and on the top of it, the industry has been supplying about 95 per cent of the domestic demand for medicines.

Over view of Last 5 Years Pharmacy Market in

BangladeshSI Number Year Taka in Crore Growth %

1 2009 5485 16.832 2010 6800 23.973 2011 8404 11.914 2012 9404 8.125 2013 10168 8.12

Ref. IMS 4th quarter report of 2009-2013

2009-13 Pharmacy Market Size is increased 85.38 %

SI No NameBusiness Value

in Crore % Growth % Over Last Year

National 10168 100.00 8.12

1 SQUARE 1972 19.40 12.55

2 INCEPTA PHARMA 1018 10.02 11.84

3 BEXIMCO 8,96 8.82 8.04

4 OPSONIN PHARMA 5,30 5.21 4.77

5 RENATA 5,05 4.97 8.75

6 ESKAYEF 4,54 4.47 4.28

7 ARISTOPHARMA 4,38 4.31 11.37

8 A.C.I. 4,26 4.19 8.69

9 ACME 3,95 3.89 5.76

10 DRUG INTERNATIONAL 3,92 3.86 10.51

Last year top 10 Company of Bangladesh

Ref: IMS 4th quarter of 2013

SI No Company Business Value in tk Crore

1 Beximco 1182 Novartis 1013 Square 864 Incepta 635 Techno Drug 46.16 Acme 24.9

7 Aristo Pharma 23.7

8 Renata 21.59 Eskafey 16.8

10 Globe Pharma 15.7

11 Biopharma 11.612 ACI 10.913 Popular 914 Opsonin 8.715 Jayson 7.6

Export Statistic 2013

What we are doing ?

Service to Qualified Doctors 1. Cash for products Prescription2. Pleasure trip (family, friends, colleague) for prescription share3. Cash or Sponsor for Personal program, such as wedding

program, birthday, akhika, different cultural program etc.4. Home decoration, chamber decoration5. Hotel room service6. Personal visiting card, Rx pad & prescription folder7. Medial Equipment & Medical Books8. Use survey companies provided prescription pad. ( which

contain carbon paper)9. Take share ( taka) from each prescription. Eg. Vitamin & food

supplement product.

10. Children tuition fee ( Domestic & overseas)11. Fix deposit or Monthly DPS for self or family person12. Exclusive gift such as Home, flat, car etc13. Personal overseas tour cost ( plane fare, hotel cost etc)14. Different food item15. Dress & cloth in different occasions16. Extra & excess sample medicine17. Use MR or MPOs for personal work- Banking work, family work18. All type of insurance coverage of physician & his family members.

Service to Medical College & General Hospital

1. Sponsor to Medical Conference & Seminar2. Sponsor to Cultural program & Picnic3. Medial Equipment & Medical Book for indoor use4. Doctors Refreshment room decoration ( Chair, water filter, TV

etc)5. Snacks, Lunch & Dinner6. Personal gift to doctor nurse & nurse.

To young Intern doctors

I. Give mobile recharge card, Internet modem & Recharge cardII. Free lunch, snacks, dinner.III. Finance in different pleasure trip & programIV. Medical book & EquipmentV. Extra Sample MedicineVI. Exclusive giftVII. Transport ticket

At OT

• OT dress• OT order sheet• Injectable Sample• OT instrument• Hand sanitizer & OT wash materials• Give sample, gift to OT boy

DMF/LMAF1. Special Discount (out of regular discount) 2. Cash for products Prescription3. Pleasure trip (family, friends, colleague) home & abroad4. Cash or Sponsor for Personal program, such as wedding

program, birthday, akhika, different cultural program etc.5. Home decoration, chamber decoration6. Medial Instrument7. Occasional gift

Some time they give below standard product due to high profit margin.

To Chemist ShopA) There are two type of discount 1. General ( all chemist shop

will get is), 2. Special discount ( it is vary)

B) Printed promotional item giftC) Special discount for selective product- such as Injectable

antibiotic, Amino acid, Injectable vitaminsD) Pleasure tripE) Sessional gift

Some time they change the brand that is prescribed by the doctor, due to biased

Over view of Cash serviceS No Company Cash Service per month Av. Sales per month

1 A 2.5 crore 90 crore

2 B 5.5 crore 105 crore

3 C 3.75 crore 65 crore

4 D 72 Lac 26 crore

5 E 24 Lac 7.8 crore

6 F 7 Lac 2.5 crore

Avg. 440 crore taka cash are given for 10,000+ crore sale

For confidentiality company name are not shown

A Case StudyIn Dhaka there is a famous diagnostic center & Hospital, situated at dhanmondi, Its name’s first later is P.

There are Total 105 is practicing, among them1.About 80 person receive different service from different companies ( by force)2.About 20 person receive not by force( if companies willingly gift)3.There are 5 doctor they do not take any kind of thing.

What should be our standard recommendations for Bangladesh ?

“Gifts are just a form of promotion or advertising, and advertising is a part of our society, like it or not ?”

Gifts:

• Cost money (like other advertising).• Influence behavior (like other advertising).• Create obligation, need to reciprocate (unlike

advertising). Conflict of interest• Create sense of entitlement (unlike

advertising).• Erode professional values; demean

profession (probably unlike advertising).

Conflict of interest

Set of conditions in which judgment concerning a primary interest tends to be unduly influenced by a secondary interest.

NEJM 1993;329:573-6

Should doctors be held to different (higher) standards?

The physician-patient relationship is a fiduciary relationship.

Characteristics of a Fiduciary:

• Has specialized knowledge or expertise• Holds the trust of others• Held to high standards of conduct• Avoids conflicts of interest• Is accountable or obligated (ethically and

legally)

World Medial Association International Code of Medical Ethics

DUTIES OF PHYSICIANS IN GENERALA PHYSICIAN SHALL

•always maintain the highest standards of professional conduct.

•not permit motives of profit to influence the free and independent exercise of professional judgment on behalf of patients.

•in all types of medical practice, be dedicated to providing competent medical service in full technical and moral independence, with compassion and respect for human dignity.•act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.

Continue……

The following practices are deemed to be unethical conduct:

a) Self advertising by physicians, unless permitted by the laws of the country and the Code of Ethics of the National Medical Association.

b) Paying or receiving any fee or any other consideration solely to procure the referral of a patient or for prescribing or referring a patient to any source.

Sources of In formations

Sources of Information

1.Irish Medical Council2. Code on Interactions with Healthcare Professionals: The Pharmaceutical Research and Manufacturers of America (PhRMA)- 2009

3. Association of the British Pharmaceutical Industry (ABPI):

Sources of Information continued

4. Organisation of Pharmaceuticals Producers of India (OPPI):OPPI Code of Pharmaceutical Practices- 2012

5.China Association of Enterprises with Foreign InvestmentR&D-Based Pharmaceutical Association Committee code

6. A Cross-sectional Analysis of Pharmaceutical Marketing Codes and the WHO Ethical Criteria for Medicinal Drug Promotion September 2006 - February 2007

7. WHO Ethical Criteria for Medicinal Drug Promotion

CODE OF PRACTICEfor the

PHARMACEUTICAL INDUSTRY

Second 2012 Editiontogether with the

PRESCRIPTION MEDICINESCODE OF PRACTICE

AUTHORITYConstitution and Procedure

ABPI

Iris Medical Council

Guide to Professional Conduct & Ethics for Medical Practitioners

Frequently asked question- relationship between doctors & industry

Edited & ApprovedNALA’s plan English Mark

October 2012

Drug Sample ??

Is it right for doctors to accept drug samples from pharmaceutical sales representatives?

•Most general practitioners (GPs) say they only accept drug samples to use as emergency medication during night calls. If the samples are used only in this way, it would be acceptable for doctors to receive them.

•Doctors must store the samples in line with their marketing authorizations and must make sure that all relevant safety and quality measures are in place to maintain the safety, quality and effectiveness of the drugs.

Irish Medical Council

• Shall not supply a free sample of a medicinal product to any person unless that person is qualified to prescribe such product, and in such case only where the following conditions are satisfied—

• The EFPIA Code is by far the most demanding international code on samples. It specifies that only a limited number of samples of a particular medicine may be provided, and this is only permitted in response to a written, signed and dated request from the health-care professional, qualified to prescribe the medicinal product [EFPIA 12.01 p10].

Sample in OPPI code: India

Samples Permitted: In accordance with local laws and regulations, free samples of a pharmaceutical product

may be supplied to healthcare professionals or to persons duly authorized by them who are qualified to prescribe

such products in order to enhance patient care. Samples should not be resold or otherwise misused.

such sample is provided on an exceptional basis only and for the purpose of acquiring experience in dealing with such a product;

the number of such samples of each product that may be supplied to any one recipient in any one year shall be limited and in any case shall not exceed six in number;

the supply of any such sample is made only in response to a written request, signed and dated, by the recipient;

the supplier of such samples maintains an adequate system of control and accountability;

each such sample is no larger than the smallest presentation of the product on the market;

each such sample is marked “free medical sample — not for sale” or words to the like effect; and

each such sample is accompanied by a copy of the summary of product characteristics for each such product.

Recommendation

1. Sample could be provided to the person only having the authority to prescribe, never for quack/ pharmacist/ chemist.

2. Should be marked as “free medical sample — not for sale”. Samples should not be used for business or otherwise misused.

3. the number of such samples of each product that may be supplied to any one recipient in any one year shall be limited.

Cash and kickback ???

Cash & Kickback

Member Companies shall not provide to a medical practitioner any cash or monetary grant for individual purpose in individual capacity under kickback or any pretext

OPPI, ABPI IFPMA, PMCPA, EFPMA

Recommendation

1. Cash/ Kickback/ commission of sells to physician either for previous prescription or future obligation is completely unethical.

2. It could be considered under criminal offense3. Prescription of drugs not approved by Drug

administration of (gov) is prohibited

Gifts

WHO Review

•In the IFPMA2006 Code, the payment in cash (equivalents) is prohibited• Contrary to the 2000 Code, in the 2006 Code all gifts for the personal benefit of the health practitioner are prohibited [IFPMA p13].• ‘The provision of an inexpensive gift, related to the practice of medicine, may be given on an infrequent basis to health-care professionals, in acknowledgment of significant national, cultural or religious holidays in some countries

American Medical AssociationCouncil on Ethical & Judicial Affairs

• “Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value.”

JAMA 1991;261:501

American College of PhysiciansGuidelines on Physician-Industry Relations

• The acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged.

• The acceptance of even small gifts can affect clinical judgment and heighten the perception (as well as the reality) of a conflict of interest..

• The dictates of professionalism require the physician to decline any industry gift or service that might be perceived to bias their judgment, regardless of whether a bias actually materializes.

Annals of Internal Medicine 2002;136:396-402.

American College of PhysiciansGuidelines on Physician-Industry Relations

Acceptable industry gifts:

• Inexpensive gifts for office use (pens and calendars).

• Low cost gifts of an educational or patient-care nature (such as textbooks). < 15 Euro/ 6 bp/ 100 USD

• Modest refreshment.

Annals of Internal Medicine 2002;136:396-402.

PhRMA Code on interactions with healthcare professionals

• Items primarily for the benefit of patients may be offered to healthcare professionals if they are not of substantial value ($100 or less).

• Items of minimal value may be offered if they are primarily associated with a healthcare professional’s practice.

• Items intended for the personal benefit of healthcare professionals (CDs, tickets to a sporting event) should not be offered.

www.PhRMA.org, April 2002

PhRMA Code FAQs

Question:

Under the Code, may golf balls and sports bags be provided if they bear a company or product name?

Answer:No.

www.PhRMA.org, April 2002

PhRMA Code FAQs

Question:

Under the Code, may healthcare professionals be provided with gasoline for their cars if they are provided with product information at the same time?

Answer:No.

www.PhRMA.org, April 2002

PhRMA Code FAQs

Question:

Under the Code, may items such as stethoscopes be offered to healthcare professionals?

Answer:Yes

www.PhRMA.org, April 2002

• It further says that“gifts for the personal benefit of healthcare professionals

(such as tickets to entertainment events) should not be offered or provided.”

Is it right for doctors to accept gifts and hospitality from pharmaceutical, medical devices or other commercial companies?

•Paragraph 59.9 of the Guide says that doctors should not accept gifts (including hospitality) from pharmaceutical, medical devices or other commercial companies.

•However, doctors can accept reasonable fees for any work they do as part of a contractual arrangement with a commercial company.

•Paragraph 59.9 also says that doctors should be aware that commercial companies may use even low-value promotional items to try and influence prescribing and treatment decisions.

Irish medical Council

Recommendation on Gift• “Any gifts accepted by physicians individually should

primarily entail a benefit to patients and should not be of substantial value.”

• Inexpensive gifts related to profession , infrequently may be given

• Low cost, educational and patient care nature eg Books may be given

• “Gifts for the personal benefit of healthcare professionals (such as tickets to entertainment events) should not be offered or provided.”

• Small gift for office use: pen, pad can be given• Cash gift is prohibited

CME/ Conference/ Events??

Events/Educational programme/CME

2 types•Organized by Pharmaceutical Industry•Organized by Professional Body Supported by pharmaceutical industry

Is it acceptable for doctors to attend promotional or sponsored educational meetings?

•A ‘promotional meeting’ is a meeting held by a pharmaceutical, medical devices or other commercial company to teach doctors about a particular new drug or device. •In general, promotional meetings do not give objective educational information and doctors should not use them for continuing professional development (CPD) points unless the event has been approved by a professional body.•The Guide also advises doctors not to rely solely on promotional literature from pharmaceutical companies for information about particular drugs and to seek independent, evidence-based sources of information on the benefits and risks before prescribing Irish medical council

Events

The WHO-ECPM: 1.The objective scientific content of a meeting should be paramount 2. Entertainment, hospitality be secondary to the main purpose of the event and kept to a modest level 3.Should not lead to any obligation to promoteany medicinal product.

The Medical Council advises doctors not to accept direct hospitality from pharmaceutical, medical

devices or other commercial companies so that their professional judgment is not affected by the

hospitality.

Pharmaceutical Research and Manufacturers of America

(PhRMA)

Code of Interaction with Health care Professionals 2009

CME: Continuing medical education

Continuing medical education (CME), also known as independent medical education (IME), helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate. PhRMA

Under the PhRMACode, what are examples of permissible items that

may be provided to educate healthcare professionals?

Items primarily designed for the education of patients or healthcare professionals, as long as such items are not of substantial value ($100 or less) and do not have a value to the healthcare professionals outside of their professional responsibilities. For example; medical text book, a subscription to a relevant scientific journal, or copies of relevant clinical treatment guidelines.

A field sales representative of Company X provides pizza for the staff of a medical office during lunch time. Is this consistent PhRMA with the Code?

Providing an occasional meal would be consistent with the Code if the sales representative will provide an

informational presentation to the medical staff in conjunction with the meal of modest value, so long as the

location of the in-office presentation is conducive to scientific or educational communication. Merely dropping

off food for the office staff, however, would not be consistent with the Code.

American Medical association/ PhARMA

American Medical Association/ PhARMA

Recommendation for Events/ CME

• Doctors can attend scientific events organized by pharmaceutical industry

• Doctors should not solely depend on the information provided by the pharmaceutical industry

• Professional organization could arrange scientific events with the support and hospitality of pharmaceutical industry

Recommendation on events continue

• Events should be primarily dedicated to objective scientific and educational activities

• Support should be accepted by conference organizer, not physician attendees• Meals must be modest• They do not cover travel, lodging, time, or

other personal expense of physician attendees who are not faculty

Recommendation on events continue

• Hospitality subsidies should be limited to modest meals or social events held as part of meeting

• Faculty honoraria and reimbursement must be reasonable

• Organizers should retain responsibility for and control over selection of content, faculty, educational methods, and materials

Recommendation on events continue

• Scholarships and special funds or trainees to attend “carefully selected education conferences” are permitted if selection of recipients is controlled by training institution

• “Legitimate” conferences or meetings are defined as having: Primarily dedicated (in

• time and effort) to objective scientific and educational activities

Recommendation on events continue

• They are convened to further knowledge on topic presented

• They ensure appropriate disclosure of financial support or conflict of interest

Recommendation on events continue

• Payment for meals by pharmaceutical companies should meet the following conditions:

• The meal is modest and is associated with valuable scientific or educational activities

• The venue is conducive to informational communication

• Guests are not included and takeout meals are excluded

Sponsorship ???

Is it acceptable for a doctor to accept sponsorship from a pharmaceutical, medical devices or other commercial company?The Medical Council accepts that payment of travel and accommodation expenses for doctors to attend meetings, either as participants or speakers, supports the aim of continuing professional development.

However, the Council says that these payments should go through unrestricted Education and Development Funds made available by the sponsoring company to the institution which is hosting the meeting or the conference organizer

Irish Medical Council

Sponsorship

“any such support must not be linked in any way with product promotion. No commitment must be sought or given in relation to the prescribing, supply or use of the company’s products.”

Sponsorship

“Where appropriate and depending on the time, location and length of the meeting, support to healthcare professionals may cover actual travel expenses, meals, refreshments, accommodation and registration fees.”

Sponsorship“It should be the programme that attracts delegates and not the associated venue or hospitality. Companies must not organise meetings to coincide with sporting, entertainment or other leisure events or activities. Venues that are renowned for their entertainment or leisure facilities or are extravagant must not be used.”

Sponsorship

Travel expenses may not be paid for spouses or other accompanying persons, unless they are healthcare professionals who qualify as participants in their own right;

WHO ReviewWHO-ECPM ,IFPMA2006,EFPIA : hospitality to meals, refreshments, accommodation, travel costs and registration fees is clear and relevant and therefore commendable for all codes on self-regulation of drug promotion. The additional restriction of travel costs to economy air travel, made by ABPI and MedA

Recommendation for sponsorship

• Payment of travel and accommodation expenses for doctors to attend meetings, either as participants or speakers, supports the aim of continuing professional development.

• Any such support must not be linked in any way with product promotion. No commitment must be sought or given in relation to the prescribing, supply or use of the company’s products

Recommendation for sponsorship

• Travel expenses may not be paid for spouses or other accompanying persons, unless they are healthcare professionals who qualify as participants in their own right

• Payments should go through unrestricted Education and Development Funds; it would be best

Is it acceptable for a doctor to accept sponsorship for research from a pharmaceutical, medical devices or other commercial company?

Doctors have a responsibility to make sure their work is not influenced in any way as a result of sponsorship or any other relationship with a pharmaceutical, medical devices or other commercial company.

Doctors should tell patients, employers and other institutions where they see or treat patients about the relationship.

If the relationship involves medical research, the doctor must make sure that the relationship does not influence the study, design or interpretation of any research data or affect the research or education in any way.

The doctor should also tell the relevant ethics committee about the relationship.

If you are paid directly or indirectly by pharmaceutical, medical device or other commercial companies or organizations to conduct medical research, you must address any potential conflict of interest arising from such payment and make appropriate disclosure in any publication of research results.

Is educational sponsorship or funding a good idea?•Paragraph 59.10 of the Guide says that, in general, educational sponsorship or funding from commercial companies should go through unrestricted Education and Development Funds. The funding should be managed without influence from the commercial company.

Paragraph 59.11 – If you receive financial support or other resources from pharmaceutical companies and/or related enterprises in connection with professional activities, including lectures, presentations and publications, development of clinical services or conducting research, you should address any potential conflicts of interest that arise. In these circumstances, your patients and any other relevant party should be informed about any potential professional relationship you have with these companies.

Summary

Thank You