If ethics came in injection shots, life wouldnt be so complicated and the government could have chosen to mandate a dose for all newborns, along with polio, TB and tetanus vaccines. But unfortunately it doesnt, and this is the reason uprooting the virus of deeply entrenched corruption from the pharma industry and the medical profession was never expected to be free of formidable challenges.
Today, the dealings between pharma companies and medicos in India are governed by a 'half-law' enforced by the Medical Council of India (MCI), which imposes a blanket ban on doctors receiving expensive gifts and favours of any kind, including travel tickets and hotel stays. While the law is complete in the legal sense, in practice it is not, as there is no parallel law to book drug firms if they are caught offering bribes to doctors. It is this gaping hole that the government is seeking to plug. But the question isare the efforts being made now headed in the right direction, and would they bear any fruits
Is govt catching wrong bus to right destination
The department of pharmaceuticals (DoP) is busy giving final touches to a set of guidelines that could soon become the overarching code of ethics for pharma companies in India. So, would the half law then become complete No, not in the current circumstances. Drug regulatory experts point out that the pharma department doesnt have the statutory power and authority to mandate such a law in the first place. So whatever code that may get framed for drug marketing companies is likely to remain voluntary in nature till such time when the Parliament grants additional power to ministry of chemicals and fertiliser (of which pharma department is a part) or through an ordinance, which is a highly unlikely prospect, says Chandra Mohan Gulhati, an eminent drug regulatory expert. And so the real chances of this voluntary code of conduct turning mandatory are remote.
The pharma department sprang into action on this matter after receiving instructions from the Prime Ministers office (PMO) to address the issue. But what escapes reason is why did the PMO not nudge the health ministry instead, which brings amendments to the Drugs and Cosmetics Act (the moot law governing the pharma industry in the country), to formulate a parallel law for pharma companies
Meanwhile, the pharma department has hosted two meetings in the past 20 days to consult various stakeholders, including industry associations, MCI, ministry of health and doctors even, so that prudent norms to regulate pharma companies behaviour could be firmed up. Multiple stakeholders present in the meeting confirmed to FE that issues such as misuse of physician samples, inducement to doctors, funding continuing medical education (CME) programmes largely dominated the agenda of the meeting.
Misuse of physician samples
There are concerns about medicine samples meant for physicians leaking out and getting sold in the open market. The government has apparently prescribed two cures. Firstwhenever a medical representative (MR) hands over a physician sample to a doctor, he should obtain a receipt from the doctor with his signature on it. Second, top 100 pharma companies by market share, which control over 80% of the total domestic drug market, assure the government that such misuse wouldnt happen. The pharma companies are mighty worried about the signature bit.
We incur a cost in making those tablets which go labeled as physician sample. If that gets sold in the open market, we actually end up losing commercially on two counts, because revenue accruing from sale of physician samples doesnt reach the companys kitty, and secondly the drug firm also loses business because had the consumer not bought these samples, he would have bought these medicines from proper channels, says DG Shah, secretary-general, Indian Pharma Alliance, an industry association of top 18 drug firms in the country.
While this may to a little extent ensure that medical representatives (MRs) do not sell these medicines, how would you ensure that doctors in small places dont sell it to their patients or send it out to the open market, a medium-sized pharma company promoter, not wishing to be named, asks.
Shah points out that large pharma firms are extremely cautious about their channels and abuse of samples and have already invested in elaborate daily electronic record systems and other checks and balances to prevent such embarrassments. Most of these promotional plans under which drug parcels are sent for doctors are usually prepared months in advance in case of large drug firms and implementation of such plans is monitored by multi-tier hierarchy, including district and regional supervisors. The doctors whom the MRs call on or visit on any day is not on their whim, but according to a predetermined plan approved by the company, says Shah. The top 10 pharma firms employ 2,500-6,000 plus MRs each, who could be covering over five lakh doctors spread across the country. A marketing head of a leading drug firm tells FE: You must understand the fundamental equation between the MR and the doctor and realise that a MR who has gone there to promote his companys product and is vying for a few minutes of the doctor is clearly in no position to insist on his sign before he hands over the sample. Simply speaking, he may never get an appointment with the doctor if he imposes pre-conditions such as this.
Gifts & CMEs
The PMOs wake-up call on the matter was partially prompted by a letter from MP Jyoti Mirdha, alleging that a reputed pharma company sponsored an eight-day Scotland trip for 15 doctors from Madhya Pradesh, a charge the firm concerned has denied.
We are also of the view that barring small brand recall items such as diary, calendar, pens and patient aids such as human anatomy chart or heart models for cardiologists, pharma firms should be barred from offering gifts, Shah says without mincing words. But pharma companies are pleading that an exception be made for CMEs. We also do not back family holidays for doctors, but we must lay down some clear provisions under which ongoing therapy advancement can be communicated to doctors. For instance, a paradigm shift is taking place in diabetes and three generations of medicines continue to be available in the market. But if the doctor is not aware of the new advancements, how can he make an informed choice while prescribing he questions.
Medical device firms are making similar demands All we are asking for is to devise a separate code of conduct for medical technology firms by taking into account the ground realities. We are definitely prepared for a cap on such costs. But a blanket ban barring medical technology firms from holding such training sessions for doctors would prove to be counterproductive, said 3M Healthcare India executive director Gautam Khanna recently. Many doctors have private practices here and when they are invited to attend such courses or workshops to upgrade their skill sets, it implies they either have to remain absent from their work for a few days or may even have to shut their clinics for a while, forgoing their income for those days. With this as the backdrop, it becomes practically impossible to convince them to attend such sessions when you are not even paying for their basic train tickets or stay, Khanna had added.
The truth is even MCI law has not been implemented effectively. Not a single doctor has been penalised under the law and we still sometimes get bills from doctors for goodies they have bought in the hope that we would pay, the promoter of a mid-size pharma firm says. Pharma companies whine that the MCI law on CME is too stringent to be practical and it should be amended.
A lesson from media
Meanwhile, the pharma industry has floated the idea of erecting an institution resembling the Press Council of India with a retired judge as its head to self-regulate the industry. While IPA conceived the idea, other industry associations such as Organisation of Pharma Producers of India, an industry body representing foreign multinationals and Indian Drug Manufacturers Association, have warmed up to the concept and are ready to pitch in. We can firm up the modalities in a months time, but are waiting for a green signal from the governments side, says Shah.
If a law has to be brought into force to address the distortion of half-law today, the government could consider amending the Drugs & Cosmetics Act.
According to Gulhati, the other ways to do it is amending the Income Tax Act and Companies Act. There can be an amendment in the Income Tax Act, saying any expenditure incurred by any pharma company or its agents that violates a provision of any other Act, currently applicable in India (referring to MCI Act), shall not be allowed as an expense in computation of tax or an amendment in Companies Act, which forces pharma companies to reveal all such details of expenses incurred on medical profession in their balance sheets. This would discourage drug firms from indulging in such practices and may invite the wrath of shareholders if the firm is listed, Gulhati recommends.
For this, however, exception would have to be made for the pharma sector in general taxation laws, a circuitous route the government may not prefer.
Moreover, in matters of ethics, historical evidence shows that imposing laws on an optimistic note acts only as a deterrent. But just like anti-bribery laws have not wiped out corruption, anti-dowry laws have failed to eradicate dowry system and a law against pre-natal detection test could not change mindsets on female foeticide in the country, to expect that simply bringing a law would completely snuff out the disturbing practices between doctors and pharma companies would be a hope in vain. At worst, these laws can serve as reminders of a utopian world; at best they could act as the starting point of a bigger change.
Law for doctors under MCI code of ethics
* No gifts from pharmaceutical or allied health care industry
* No junkets inside the country or abroad from pharmaceutical or allied healthcare industry
* No cash or monetary grants. Funding for medical research, study, etc, only through approved institutions under specified guidelines
* Allowed medical research projects funded by pharmaceutical and allied healthcare industries on certain grounds including due permission from competent authorities
* To maintaining professional autonomy
Quantified punishments by MCI
* Gifts worth R1,000-5,000: Censure on travelling abroad for work or studies.
* Gifts between Rs.5,000-10,000: Name struck off medical register for three months, plus censure
* Gifts between Rs.10,000-50,000: Suspension from practice for six months, censure
* Gifts worth Rs.50,000-1 lakh: Licence suspension for a year
* Gifts worth over R1 lakh: Suspension for more than a year
MP Jyoti Mirdhas presentation to pharma pricing GoM
* Marketing expenses of top 50 companies: R5,340 crore a year that generates sales of R28,769 crore
* 18.56% of total income spent on selling expenses, which means R1,33,500 per doctor per year, the highest among all manufacturing activities
* Profits earned by pharmaceutical companies in the past were primarily used in promotional activities and foray into other businesses
* In April 2007, one company spent R10.5 crore to fly 1,300 doctors with spouses to a holiday resort in Bali for five nights to participate in a two hour clinical conference. Not a solitary case
Domestic pharma industry disputes these figures
CMIE data of 332 companies for FY 2009-10 shows total selling and distribution expenses of the pharmaceutical industry was R6,699 crore on sales of R92,956 crore, averaging 7% of sales