Dr. (Prof.) Mahesh Baldwa,
M.D,D.C.H, FIAP, MBA, LL.B,LL.M , Ph. D(law)
SENIOR PEDIATRICIAN & MEDICOLEGAL ADVISOR
Formerly Assistant Professor of Pediatrics at T.N. Medical College and Nair Hospital, Mumbai-400008
Ex. Asst. Professor JJ Hosp, Grant medical college
Ex.Professor, paper setter & examiner of law to postgraduate students of University Department of Law, University of Mumbai
Baldwa Hospital, Sumer Nagar,S.V. Road,
Borivali (West)Mumbai 400 092
Cell 09322990138
INTRODUCTION:
To make the rules stringent for doctors, MCI amended the code of ethics on December 10, 2009. A new section—6.8.1—was added. Since, it appeared self regulation was as bad as no regulation ! Hence MCI regulation 2009. Notwithstanding the strict code of conduct for doctors under the Medical Council of India’s code of ethics, the freebies given to doctors are many and at many levels.
MCI -THINKING
MCI considered promotional activity is nothing short of bribery.
MAJORITY OF DOCTORS THINK
Why there should be another rule for doctors, who are already saddled with multiple rules and regulations. It’s not fair to only crucify doctors and dub them as corrupt. Greed and violations run across all profession, so why single out doctors? On the contrary, doctors do the maximum amount of charity.”
YOUNG DOCTORS THINKING
But our younger colleagues are proud to have illicit relationship with drug companies! Younger generation no longer consider this as an offense , since they are born and brought up with capitation fee as their principal fodder. Commercial forces have taken over medical profession. Many of the colleges are owned by politicians, business barons and alcohol manufacturers / vendors in India. It is a well known fact, MBBS seats are now sold for 50lakhs and MD seats between 75 lakhs to 3 crores in year 2013.
LATEST DEVELOPMENTS IN PHARMA INDUSTRY
After banning doctors from taking gifts and sponsorship from pharmaceutical companies, the government seems to be backpedalling by trying to amend the medical code of ethics to legalise travel and hospitality sponsorship for doctors by pharma companies. Drug manufacturers seem greatly concerned about how poorly informed Indian doctors would be without access to company-sponsored scientific meetings to keep them up-to-date with the latest developments in medicine. This has so worried the pharma industry that the department of pharmaceuticals under the ministry of chemicals and fertilizers has sent a draft of what amendments should be made to the code of ethics to legalise drug companies’ sponsorship of continuing medical education (CME) sessions, that is conferences for doctors again. It seems the pharma companies are worried about the new MCI (Medical council of India) guidelines that restrict sponsorship for conferences and freebies to individual doctors. They think it is a big setback as it may interfere with doctor’s education and knowledge!
HOW PHARMA INDUSTRY SLOWLY MARCHES AHEAD TO MARKET THEIR PRODUCTS
It begins with some teasers. A pen, a calculator, a vanity bag, a dinner set and so on — things that cost no more than Rs. 2,500. It is the response at the receiving end that changes the game in the nexus between pharmaceutical companies and doctors. In the second stage, the doctors opt either for cash or goods. Some of the most popular gifts are home appliances — a mixer-grinder, a television or a refrigerator. The value of the freebies climbs up when the potential of the doctor is high in promoting the drugs or in prescribing investigations at the diagnostic laboratories. There has also been an instance in which a company set up a home theatre for a doctor. A plasma television or a car for which monthly installments are paid by the pharmaceutical company are common these days. However, these gifts have become passé as some doctors have switched to all-expense-paid trips abroad. In fact, it is learnt from the medical community that the Asian locations are not preferred for these foreign trips sponsored by medicine manufacturers. Europe and the U.S. are the destinations in demand.
HOW BIG PHARMA COMPANIES MARKET
Big pharma companies continue to dole out gifts to doctors as lavish as cars and televisions and to pay for international trips despite voluntary strictures and government censure. “There is no let-up in this evil practice and the pharma companies continue to sponsor foreign trips of many doctors and shower with high value gifts like air conditioners, cars, music systems, gold chains, etc to obliging prescribers who then prescribe costlier drugs as quid pro quo. In a conference of 5,000 doctors, one would hardly find 500 doctors in the conference hall.
2009 -2013 -PHYSICIAN-PHARMA INDUSTRY RELATIONSHIP
The physician-industry relationship has been a subject of considerable focus in recent years. It is a shocking transgression of medical ethics that despite a ban imposed by the Medical Council of India in 2009 on medical practitioners and their professional associations from taking any gifts, cash or monetary grant from pharmaceutical and allied health sector industries, the practice is continuing with impunity. Besides being against medical ethics this puts extra financial burden on patients as doctors prescribe costly medicines supplied by these pharmaceutical companies in preference to cheaper available alternatives. There is a tendency too for inappropriate and irrational prescriptions by doctors who are beholden to specific manufacturers. Doctors’ prescribing should be based on evidence of what is best for patients rather than commercial influences. Only time will tell whether these are mere pious intentions or that they will be implemented in letter and spirit. Such malpractices stem from a shocking lack of accountability in the medical profession. There is poor deterrence against recalcitrant doctors and pharma companies. With direct funding coming under scanning, the companies will now look for alternative routes to provide such benefits to their favoured doctors.
IDEAL CONDUCT OF A DOCTOR
When a doctor recommends a medicine, laboratory investigation or treatment to a patient, the recommendation should be purely guided by what is best for the patient. Any other influence is totally unacceptable, entirely unethical and against all tenets of the Hippocratic oath all doctors are required to take. Pharmaceutical companies and physicians have an interdependent relation. This interaction has attracted a lot of attention in recent times, primarily because the fundamental ethical duty of the physician is to provide the most effective treatment to patients and the key motive of pharmaceutical companies is to extract the maximum possible profit out of their dealings.
MCI regulation Law Cited: 6.8.1 in dealing with Pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below:-
a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry and their sales people or representatives.
b) Travel facilities: A medical practitioner shall not accept any travel facility
d) Cash or monetary grants: a medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed.
LEGAL LOOP HOLES DISCOVERED BY PHARMA INDUSTRY AND DOCTORS BOTH
1. MCI 6.8.1 does not cover associations and trusts
2. Unless the doctors is proven to be a beneficiary he cannot be implicated
3. In charitable societies members are not suppose to take monitory benefits
4. Societies should not be funded or their activities sponsored by companies and doctors members have conflict of interest.
5. Endorsement by association is seized by the High Court.
THE STATUS REPORT OF DOCTORS PUNISHED BY MCI
2009-10
769 complaints against doctors were received by MCI in 2009-10 and registration of 16 doctors was suspended temporarily and warnings issued to six doctors, while remaining 254 cases were referred to states.
2010-11
In 2010-11, a total of 824 complaints were received and 468 were referred to State Medical Councils/ governments while registration of 10 doctors was suspended temporarily and warnings issued to four doctors.
2011-12
a total of 702 such complaints against doctors have been received by the MCI in 2011-12, of which 343 have been referred to state Medical Councils/governments, while registration of three doctors has been temporarily suspended and one doctor has been given a warning and 168 cases are under consideration of the MCI.
WHY MCI & GOVT. IS NOT ABLE TO STOP THE MENACE
In 2009, the MCI had set forth guidelines for doctors vis-a-vis pharmaceutical companies. “But that was just a half measure. MCI has no jurisdiction over pharmaceutical companies. Hence the government proposes to make the existing provisions more stringent through ‘Uniform Code of Pharmaceutical Marketing Practices’ (UCPMP) proposed by the Department of Pharmaceuticals. IT act 1961 says in Explanation to Section 37(1) which disallows expenses that are in violation to any law of the land. I-T depart is also going to tax pharma firms spending on freebies for doctors. The income-tax department would tax the amount pharmaceutical and allied health sector industries spend on freebies for medical practitioners and their professional associations. Those who accept the freebies will also be taxed. Moreover, those who received these freebies will also have to pay tax on the value of the gift or the money spent on them. For instance, if a doctor received a fridge as a gift, its market value will be treated as his or her income.” The department has asked assessing officers take an appropriate action.
The government should now amend the Companies Act in such a manner that so that companies have to mention in their balance sheets expenditure incurred on doctors or medical associations but disallowed by the IT Act.
The Indian pharmaceutical industry associations-Indian Drug Manufacturers’ Association (IDMA) and Organization of Pharmaceutical Producers of India (OPPI) – have their own codes of Pharmaceutical Marketing Practices, which focus on ethical promotion of medicines to healthcare professionals but not effective.
IN USA, WHAT THEY DO
“In the US, companies are asked to mention on their websites all details of the expenses made to doctors and associations under sunshine law.”
STRONG POINTS AND SHORT COMINGS OF THE ABOVE SAID MCI REGULATION ARE:
In simple words, what the above states is that a medical practitioner should not accept any gifts, travel facilities, hospitality, cash or monetary grant, etc for himself or his family. However, it apparently permits some of these being channeled through an association or institution. The importance of the regulation lies in the fact that now the following would become possible:
1—Anybody can complain to the medical council that a doctor is violating regulation 6.8.1 and, acting upon the complaint, the medical council can punish the doctor as per law.
2—A consumer can complain to the consumer court that the service provided by a doctor was deficient or negligent because he prescribed a medicine or appliance or test etc wrongly or unnecessarily in return for favours granted by the pharmaceutical company, even though acceptance of such favours was illegal.
3—The ban is apparently only on travel facilities for vacation or for attending conferences, seminars, workshops, CME programme etc as a delegate. Giving a lecture seems to be excluded.
4—The practice prevalent among physicians of accepting gifts from pharma companies for promotion of their products is against law. It is specifically banned by the MCI Regulations, 2002. Similar ban operates in USA and other countries.
5—The practice prevalent among pharma companies for giving gifts in order to promote their products was not covered under any law so far. Around mid-2012, the Department of Income Tax has issued instructions that expenditure incurred in this connection by the pharma companies would not entitle them for claiming any tax benefits.
6—The question of promotion of pharma products is intimately linked with the practice of promoting brand names of drugs. The Drug Controller General has taken a decision around August-September, 2012 that no permission for brand names would be given in future.
7-The provisions of the MCI Code seem to fulfill the need for a legal mechanism. However, the code has been criticized, as it did not prescribe any penalty for the doctors who violate the provisions. In response, MCI has suggested various degrees of punishments for doctors who accept gifts worth Rs.1000 from any pharmaceutical or allied healthcare company. The punishments range from censure (for accepting gifts valued between Rs.1,000 and Rs.5,000) to removal from the Indian or State Medical Registry for more than one year (for accepting gifts worth more than Rs.1,00,000).However, there are still questions about the process of monitoring, and complaints. Besides, the code does not have any actions for the industry.
8-the term “approved institution” is ambiguous. the term “consultant/advisor” is ambiguous. This provision can be misused for paying fees to a private medical practitioner by appointing him/her as a consultant/advisor. However, if it is meant to cover medical practitioners working as fulltime medical advisors in pharma industry, it will support the medical advisors working in pharma industry in withstanding pressures of marketing departments and in exercising their professional autonomy.
The objectives of the code can be served only if the MCI provides explanatory notes for ambiguous provisions and creates a robust mechanism for monitoring and implementation. Also, this MCI effort needs to be supported by other stakeholders – state and central government, professional medical associations and healthcare industry.
If the new regulations are implemented effectively by the Government, then dramatic change in the prescription share of various companies in the next 3 to 5 years . Thus, the brand name game in the pharmaceutical marketing space is not going to vanish in immediate future. Promotion of generic names needs the winning innovative ideas, whose time has just become ripe.
WHY PHARMA COMPANIES WOO DOCTORS
“Drugs for diabetes, hypertension and chronic renal diseases are the fast-moving drugs and in large volumes,” said a former Health Services doctor. These drugs face the toughest competition in the market because of the large varieties available, and a doctor can be a big help in pushing up the sale of a favourite.
A cholesterol lowering generic drug Atorvastatin is believed to have nearly 150 brands. And the price ranges somewhere from Rs. 40 to Rs.150 for ten tablets of 10 mg each. Likewise, a gastritis drug Pantoprazole has about 250 or more brands and may vary in cost from something over Rs. 20 to about Rs. 100.
Another category of drugs that face tough competition is antibiotics. Cancer drugs and psychotropic drugs are others that require long-term use, bringing more brands and competition and price ranges.
CONCLUSION:
Both doctors as well as pharma industry shall keep striving for better ethical, legal framework but one cannot ignore unethical rigorous marketing by pharma industry luring unethical doctors to boost pharma sales in all the time to come. Who wins? Or could it be win-win situation for both pharma industry and doctor with approval of government regulations. Only time will tell.
