The relationship between intellectual property (IP) rights & drug efficacy and safety

Without any meaningful input from patients, intense efforts are underway at the WHO to weaken – or dismantle – the system of intellectual property (IP) rights that has produced nearly every life-saving medicine that is available today.  On behalf of a variety of both public and private sector special interests, anti-IP NGOs are using the Intergovernmental Working Group on Intellectual Property and Public Health (IGWG) as a vehicle to weaken the rules for drug innovation and development by promoting the expropriation of patent rights through compulsory licenses.

Issues of innovation, access and safety are of keen interest to patient advocates. The regulatory framework that supports a healthy patent regime is entwined with standards of safety & efficacy and is threatened by the proposals to weaken patent rules that are currently before IGWG.

Last summer, Bright Simons wrote an article that examines the relationship between patents and drug safety and efficacy.  According to Simmons:

Without clear patents and robust licensing regulations, the incentive to enforce standards disappears. Patents need not be owned solely by individuals or firms. They may also be owned by communities. But whoever owns these patents would be able to license them for revenue, and will therefore be much greater disposed toward ensuring adherence to standards by licensees. Without patents governments are likely to be solely responsible for enforcing standards. A licensing regime brings in more self-interested brand managers and intellectual property trustees. Hence, the efficacy of standards and the health of any patent regime are intimately intertwined.

Recent events in the East African country of Ethiopia illustrate this principle very well. Late last year, the country’s health and safety watchdog (DACA) withdrew the licenses of some 60 pharmacies representing Indian generic drug manufacturers. The action was prompted by the outcome of a series of working tours conducted by DACA personnel in India during which extensive evidence was uncovered that showed a high rate of negligence among some India drug makers in complying with internationally recognized standards of drug manufacturing. In many cases, the medicines that some of these companies were busily marketing to Ethiopians through local intermediaries had never passed any well-supervised clinical trial. There were even instances of outright fraud in which some of the drugs sent to Ethiopia from India were misrepresented as other, more standards-compliant, drugs. The Ethiopian authorities felt that they had no choice than to bar the entry of many Indian generics in order to protect the health and well-being of the Ethiopian people.

It follows without need for much argument that if standards suffer due to the absence of robust patent regimes, commercial prospects are similarly undermined. This is a piece of common knowledge not amiss anywhere, not even in India, the home in Asia of the patent-busting movement.