Disputing Distribution: Ethics and Pharmaceuticals in Nepal Nabin Rawal, Ian Harper and Madhusudan Subedi

Pharmaceutical Industry in Nepal $100 million per year in Nepal and increasing Approx. 30% of the market Nepali products, but still dominated by India Over 45 Nepali companies No export (as of yet)

The Context: On July 19th 2007, the Government of Nepal, through its Department of Drug Administration (DDA) released its Guidelines on Ethical Promotion of Medicine The objective of this guideline is to promote ethical promotion of medicine to support and encourage the improvement of healthcare through the rational use of medicine and discourage unethical practices. (Drug Bulletin of Nepal, “Ethical promotion of medicine: Benefit to consumers”, 2007)

The guideline dwells on a number of issues, for instance: - information to physicians and health related professionals - Information to general public - Advertisments - Company procedure and responsibilities - Medical Representatives (MRs) - Free sample of medicine for promotional purposes - Symposia and other scientific meetings among others But what is interesting is that the issue of ‘bonus’ has come to take center stage.

Antecedents of the Guideline In 1988, WHO had published a concept on Ethical Criteria for Medicinal Drug Promotion. DDA commissioned a group of pharmacists to conduct a study on the Promotional Practices of Pharmaceuticals in Nepal. With the consent from all the “stakeholders”, DDA put the guideline into effect on Shrawan 3, 2064 (2007/07/19).

Guideline: Claims and Counterclaims

Graduate Pharmaceuticals Association of Nepal (GPAN) The “Why” of the Guideline Wide variation in bonus scheme offered (Offers ranged from 10 percent to 100 percent depending on the product) No offer system in sale of some product Conclusion: Business practices should meet high standards of ethics and legal compliance

Nepal Chemist and Druggist Association (NCDA ) The Guidelines on Ethical Promotion of Medicine 2007 should be abrogated (why??) Drawn up unilaterally Reduction in bonus must give way to reduction in prices of the pharmaceuticals ( DDA in cahoots with producers) Guidelines not in consonance with the context of the country (Regulation of “unregulated” market with paramedics expansion into this trade) DDA focused on “deal bonus” but did not attend to other issues put forth by NCDA when the president was called just before the guideline was to be issued

Nepal Medical and Sales Representative Association (NMSRA) NMSRA should be registered in the DDA Foreign companies distributing drugs in Nepal should either open their office in Nepal or the importer is made responsible on their behalf. APPON and individual manufacturing companies want to make our job less secure. (uniformity in salaries and benefits) Link between pay and sales levels rescinded

Association of Pharmaceutical Producers of Nepal (APPON) Rise of competition gave way to rise of gifts and bonuses Regulatory mechanism of Nepali pharmaceutical market is yet to be developed. Different pharmaceutical producers--various companies to be consulted before developing the code of conduct for ethical marketing in Nepal. “Deals” make it easy to compete—open border and Indian companies offering bonus We will abide by the government (less bonus means the price in medicines will decrease)

Nepal Medical Association (NMA) Doctors not to blame for the anomalies Giving calendars, pens, diary is widely acceptable all over the world Doctors and retailers not taking gifts but pushed by the manufacturers A body consisting of all “stakeholders” must work to eliminate malpractices. DDA has started a correct move

Nepal Medical Association (NMC) We are bound by our own Code of Ethics DDA responsible body for quality control APPON should ensure fair business within the companies. NMC ready to punish corrupt doctors if found indulging in malpractices

Department of Drug Administration (DDA) Guideline responsibility of the companies but no action lead to DDA’s issuance of the guideline to control anomalies in the market Formation of a committee to look a the issue of fixing of prices for 22 items Bonus has been capped to percent upon the request of the producers Some companies’ “under the table” activities have discouraged companies adhering to the code

Currently, trying to curb “unethical” promoting” in the form of bonus and substitution Importer- Onus on imported drugs Currently, guidelines watered down on the bonus issue at the expense of others.

Discussion 1. Public welfare Vs Business (The Paradox)

2.“Ethics”—a relative positioning

3.Blame game rather than self- introspection of ones practices

5. What is at stake—In the face of emergent Nepali pharmaceutical industry is it about struggle and capture of generic market?

5. Different Actors different stances– How then should regulation be undertaken?