A VIEW ON THE ROLE OF PATENTS IN ANTI-BIOTIC RESISTANCE
There is a fundamental conflict between a desire to maximise profits by selling a patented antibiotic and public health threats.
The worldwide use of antibiotics in hospitals, by family practitioners and in husbandry (to fatten animals) has created a problem whereby millions of people are hospitalised each year for multi-drug resistant bacterial infections. Every dose of antibiotics creates selective evolutionary pressures, whereby bacteria survive to pass on genetic mutations.
It is possible that we are at a stage were human innovation is no longer capable of outpacing bacterial mutation which is possibly a result of abusing incentives for producing antibiotics.
A survey which was done in 2004 of fifteen major pharmaceutical companies, including Merck, Pfizer and Johnson & Johnson showed that of 506 drugs undergoing research and development, only five were antibiotics. It has been noted that in the last 30 years no significant new antibiotic has been put on the market.
A major cause for the decline in antibiotic development is the poor return made by the companies. This is because antibiotics are short-term therapies that completely cure their target diseases. The costs of developing a novel antibiotic is also extremely high, and is not considered a good investment.
One way in which pharmaceutical companies try to mitigate against this poor return is to push the sales of a specific antibiotic during the drug’s patent lifetime.
According to Horowitz JB the resistance to a specific antibiotic tends to increase when the patent on the antibiotic reaches its expiry date. This could be due to the sales which were pushed during the lifetime of the patent and because, upon expiry of the patent, there is a significant decrease in price and an increased availability of the specific drug.
The international intellectual property regime provides an environment which encourages pharmaceutical companies to develop and market drugs to maximize private profits, rather than benefit public health. Thus a pharmaceutical company is not generally willing to preserve the efficacy of a patented drug by limiting the use thereof, before the patent of the drug expires and generics can enter the market.
One way in which to increase the longevity of existing drugs (i.e. the effectiveness) might be to reduce the use of medically relevant antibiotics and to use new drugs only when they become absolutely necessary. This, however, directly impacts on the incentive to develop and produce new antibiotics.
The Infectious Diseases Society of America (“IDSA”) has strongly advocated the extension of patent protection for novel antibiotics to allow pharmaceutical companies to enjoy exclusive markets for longer. The belief is that the companies will have a longer period to generate profits to recoup investments and they will be encouraged to reserve antibiotics for future public health threats.
The downfall to this suggestion is the fact that prices will remain higher for longer and poor countries will be negatively impacted.
According to the World Health Organisation, the world is entering a “post antibiotic era” and if a solution is not found this could represent the greatest threat to public health in the twenty first century.
Monty Rademeyer – Partner