Will There Be a ‘Sunshine’ in India?

by buildingpharmabrands

Sunrise Act

Paradoxical as it may seem there is no Sunshine (ACT) in India. Not yet. The Times of India article on the Bid to Legalize Pharma Companies’ Sops for Doctors dated April 19, 2013, casts a permanent cloud whether there would ever be an ACT similar to the Sunshine Act of the US governing payments to physicians.

The ever-increasing and seemingly never-ending corrupt practices involving physicians and pharmaceutical industry is difficult imagine. There seems to be a sort of contractual relationship that is mutually rewarding between a number of physicians and some Pharma companies. It could be payments in cash or kind, huge discounts to the pharmacies owned or sponsored by the prescribing physicians or as services that include paid vacations for the family in India or even abroad or expensive to very expensive gifts.

The Ethical Codes are well defined both by the OPPI (Organization of Pharmaceutical Producers of India), the industry organization and the MCI (Medical Council of India), the regulatory body for medical practice and practitioners in India. Both seem to be toothless paper tigers, who cannot ensure compliance from their respective members.

What is alarming, is the lack of any kind of public discussion or outrage at the implication of legitimizing sops to physicians. Already rampant is the systemic disregard for transparency in financial and other interactions between members representing the Pharmaceutical industry and the physician community. The current proposal can only serve as an attempt to legitimize the feeble deterrents to the current questionable practices despite  the OPPI Code and MCI guidelines (details below). It’s not about the Code or guidelines. It is about their implementation. Once the principle of transparency in all transactions replaces the current practice of total concealment, things are most likely to fall in place. In this context, the Physician Payments Sunshine Act in the US and the American Medical Association’s view on CME are worth emulating.

OPPI Code

  1. No financial benefit or benefit-in-kind may be provided or offered to a healthcare professional in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so. Nothing may be offered or provided in a manner or on conditions that would have an inappropriate influence on a healthcare professional’s prescribing practices or would influence their professional integrity and autonomy or will compromise patients interest in any manner
  2. Member companies or their representatives shall not give any travel facility inside the country or outside, including rail, air, ship, cruise ticket, paid vacations, etc., to healthcare professionals for self and family members for vacation or for attending conferences, seminars, workshops, CME program etc, as a delegate.
  3. Member companies or their representatives shall not give any travel facility inside the country or outside, including rail, air ship, cruise ticket, paid vacations, etc, to healthcare professionals for self and family members for vacation or for attending conferences, seminars, workshops, CME program, etc., as a delegate.
  4. Member companies shall not provide any hospitality like hotel accommodation to healthcare professionals and family members under any pretext except when they are engaged in advisory capacities as consultants, as researchers, as treating doctors or in any other professional capacity.
  5. No entertainment or other leisure or social activities should be provided or paid for by member companies.
  6. Member companies shall not provide to a medical practitioner any cash or monetary grant for individual purpose in individual capacity under any pretext.
  7. Member companies or their sales people or representatives shall not provide any gift to a medical practitioner.

MCI Guidelines

  1. No gifts from pharmaceutical or allied healthcare industry
  2. No junkets inside the country or abroad from pharmaceutical or allied healthcare industry
  3. No cash or money grants. Funding for medical research, study etc, only through approved institutions under specified guidelines
  4. Allowed medical research projects funded by pharmaceutical and allied healthcare industries on certain grounds including due permission from competent authorities
  5. To maintain professional autonomy

Penalties Quantified by MCI

  1. Gifts worth ₹1,000 – 5,000: Censure on traveling abroad for work or studies
  2. Gifts between ₹ 5,000 – 10,000: Name to be struck off medical register for three months, plus censure
  3. Gifts between ₹ 10,000 – 50,000: Suspension from practice for six months, plus censure
  4. Gifts worth ₹50,000 – 100,000: License suspension for a year
  5. Gifts worth over ₹100,000: Suspension for more than a year

Less than a year ago, when the Congress, MP, Jyoti Mirdha stirred up the hornet’s nest of physician payments by Pharma through a letter to the Prime Minister, the 45 Parliamentary  Standing Committee report recommended that appropriate regulations be added to the drugs and cosmetics rules to prohibit the pharmaceutical manufacturers from offering such freebies that are prohibited under MCI rules.

The government seems to be backpedalling the decision of ban on the gifts and sponsorships of physicians by Pharma companies to day giving to the pressure of respective lobbies. The reason for such a round-about-turn? The department of pharmaceuticals explains in a letter: Most of the hospitals / institutions in India do not have any provisions to send doctors to congresses and conferences. Appropriate support from pharmaceutical and allied healthcare industries will enable the Indian doctors to get access to the latest developments in medical research, which in turn will enable them to improve the level of patient care in India.

AMA (American Medical Association) on CME 

Compare this with what the American Medical Association’s Journal, Virtual Mentor, said about CME (Continuing Medical Education): Industry support of CME activities should be limited to contributions to a central fund that would disburse the money to programs accredited by the Accreditation Council for Continuing Medical Education. Only CME activities that are entirely free of direct pharmaceutical industry funding should qualify as education. The best solution would be that the education of physicians be funded by physicians, not by a third party, whose profits are directly related to prescribing behavior.

Brinda Karat, a member of Rajya Sabha said in this context: It is absolutely shocking. This is not what was told to Parliament about bringing about reforms to put an end to the practice of Pharma companies bribing the doctors. We will definitely be taking this up in Parliament.

What is even more disturbing is the process of concealment instead of disclosure of such payments. Even after making the payments to physicians by Pharma companies taxable from the earlier tax-deductible status as marketing expenditure, it does not deter anyone from doing it. What is needed is transparency. Disclosure. Disclosure of the amounts paid and for the purpose for which they paid. Once that information is made public, it would probably bring in the necessary change through social pressure, albeit gradually.

Sunshine ACT in the US

Two Senators – The Republican Senator from Iowa, Charles Grassley and Herb Kohl, the Democratic Senator from Wisconsin introduced the Physician Payments Sunshine Act to bring transparency to the pharmaceutical industry in the US. The Act will change the face of drug research and development by enhancing transparency between drug makers, physicians and the public. Here are the major requirements of the Sunshine ACT.

  1. Pharma companies need to make the information available for the public regarding all payments made to the physicians giving details such as: the name of the physician, or the teaching hospital along with address; the amount value of the payment or other transfer value; the national provider identifier for the physicians; the dates on which the payment is made; a description of the form of the payment or the transfer value – cash or cash equivalent in kind, items or services; stock or stock option or any other ownership interest, dividend, profit or other return on investment; a description of the nature of payment or other transfer value as – consulting fees; compensation for services other than consulting such as honorarium, gift, entertainment, food and beverage, travel and lodging, education, research, charitable contribution, royalty or license, current or prospective ownership or investment interest, direct compensation for serving as faculty or as a speaker for a medical education program, grant etc. Pfizer has been reporting all its payments to physicians from 2010.
  2. By 2013, pharmaceutical and device manufacturers in the US must report all gifts and payments greater than $10 made to physicians and hospitals. If the gifts or payments valued are less than $10 but exceed $100 annually should also be reported. Failure to submit the required information result in fines: $1,000 to $10,000 for each payment not fully reported with a cap of $150,000. Any applicable manufacturer that knowingly fails to accurately and completely submit required information in a timely manner is subject to pay a penalty of between $10,000 and $100,000 for each payment that is not reported with a cap of $1,000,000. The database will go live by September 2014.

It is worth noting, remembering, reflecting and practicing what Dr. Jeremy A. Lazarus, President, American Medical Association, wrote in an online communique as reported on February 4, 2013: The AMA will carefully review the new Physician Payment Sunshine Act Rule. Physician’s relationships with the pharmaceutical industry should be transparent and focused on benefits to patients.

Will there be a Sunshine Act-like legislation governing the payments to physicians by Pharma in India? There was at least a hope that someday there might be. But not now. Not after this bid to legalize Pharma companies’ sops for doctors.