Opinion A dose of transparency

The bulk of innovation in the drug industry has taken place in Europe and the US. These developed countries have a reasonable system of health insurance that pays for the treatment cost. Due to an environment where direct marketing is allowed,pharma companies spend millions of dollars,more than Coke and Pepsi combined. To deflect any criticism related to drug pricing,companies hide behind the veneer of corporate social responsibility,often through their presence in underdeveloped markets. Drug regulatory bodies,in the absence of a strong legislative mechanism,are toothless and unable to enforce quality standards and are instead part of the regime that milks consumers,insurers and public funds alike. It helps to preserve the status quo because it is so richly rewarding in terms of stock options and millions of dollars in payouts to those who have perfected the art of gaming the system.

The Indian patent law does not recognise evergreening,that is,small changes in the chemical constituents of a drug’s active molecule to grant marketing exclusivity. Indian firms have employed this to their advantage by manufacturing and selling cheaper copies of the original molecules. Yet,their contribution to original research is zilch.

Every drug has an active ingredient and an excipient that is pharmacologically inert. When ingested,it has a specific mechanism by which it affects the body and undergoes breakdown. It has to reach a certain concentration in the systemic circulation to be able to exert its biological effect. This is called bioavailability and is an essential component of pharmacokinetics. A generic molecule should be able to demonstrate equivalent kinetics. The comparison study between the kinetics of a generic and an original molecule is called bio-equivalence. In the absence of this crucial data in the public domain in India,it is impossible to take marketing claims of “good manufacturing practices” without a handful of salt. The prescription of these drugs involves a leap of faith because it is unknown whether they really reach the desired levels in systemic circulation. Worse,the fiduciary and fringe benefits that influence prescriptions are difficult to discount.

A comparative price index shows minimal difference in the retail price of the orginal Novartis drug in question,Gleevec,and its Indian equivalent,Glivec. Before making cursory noises about the huge price difference between the Western and Indian prices,it would be instructive to head over here: drugsupdate.com/brand/showavailablebrands/65.

Here is a simple pointer. Imatinib needs to be taken once or twice a day,often for years together. Do the math and the prices would nearly be equivalent. It might be preferable to prescribe the original molecule,since its bioequivalent studies are on record. The jury is still out on Indian generics.

Let Novartis or any pharma company bring out their audited reports in the public domain,listing the quantum of investments in research. Let them demonstrate that by stopping the flow of funds,it is going to adversely affect drug discovery. If they are conducting a trial,let them list the drug under study,the place as well as the institutional review board,detailing the restrictions,if any. This should be a good enough exercise before they complain about slowing down “innovation”. In the interest of patients,let the government of India bring out a white paper on the price control order and bio-equivalence studies,including the detailed methodologies used to evaluate a company’s merit and claims before they are allowed to market the drug.

This is not to hold the drug industry culpable for this mess.

A thriving industry is needed,but pro-consumer regulatory measures tend to evoke collective whining from the chamber of commerce. Mercifully,the SC kept the interest of Indian nationals first. Drug pricing and control is imperative if public health is a paramount principle. Unfortunately,the government,in its present dispensation,sticks with fossilised ideas and is paralysed in its ability to take decisions.

The writer is a practising oncologist,express@expressindia.com