This is a story of corporate greed, and the lengths to which the world's only superpower will go to ensure its voracious appetite is assuaged. It also illustrates the folly of attempting to humanise capitalism by negotiation. Greedy bullies will not be dissuaded from their gluttony whatever the human costs.
Countries have the right to protect the public health of their population. This is set out in the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This right was reinforced in 2001 by the historic Ministerial Declaration on TRIPS and Public Health, known as the Doha Declaration. The Doha Declaration places the protection of public health over and above private commercial interests. It gives countries the right to overcome patents in order to protect public health and allow access to medicines for everyone.
However, wealthy pharmaceutical industries are not taking this threat to their profitability lying down. They refuse to accept the primacy of health over commercial interests, and are pressurising wealthy countries, the United States in particular, to negotiate bilateral and regional trade agreements that undermine the Doha Declaration. One by one, therefore, countries are trading away their people's health to the United States in deals that deliberately restrict the availability of low-cost medicines. These agreements are negotiated in secret, and are the preferred choice of industry since they bypass the compromises of multilateral negotiations.
The negotiations wholly reflect the aims of the industry representatives who advise the US Trade Representative, and seek to introduce the following provisions;
1. The transformation of national drug regulatory authorities (NDRA) into patents enforcers. Currently the procedures for the patenting and registration of drugs are entirely separate, but the US want NDRAs to prevent the registration of cheaper generic versions of a drug where a patent is already held by one of their companies. This in effect is a ban on generic versions of patented medicines.
2. The imposition of data exclusivity. This would introduce new obstacles on test data that will delay the registration of generic medicines. In order to register a medicine with a NDRA, the applicant must demonstrate that its medicine is safe, effective and of quality. However, only the first applicant must show clinical trial data to prove the drug's safety and efficacy. The US wants exclusive rights over pharmaceutical test data for originator companies. Therefore generic drug producers will have to produce their own data. This will be a disincentive and delaying factor in the production of cheaper generic drugs.
3. Extension of the length of patents. Patents on drugs usually last for 20 years from the date of filing. A patent is applied for at the basic research stage, well before the application for drug registration. Registration occurs some 2-3 years later. The US wants to extend the patent life to make up for the time between patenting, and registration. This will result in lengthening the period of monopoly.
4. Measures which will allow companies to re-patent their drug for each new use discovered. This will give companies the opportunity to perpetually renew their monopolies for that particular drug.
5. Restrictions on a country's use of compulsory licenses. Compulsory licenses allow the production or importation of a generic medicine without the consent of the patent holder. These are issued to address the requirements of public health or other emergencies. The US wants to impose strict limitations under which these compulsory licences can be issued. They propose that they are limited to declared national emergencies only.
The consequences of these restrictive practices will only serve to add to the millions who suffer chronic sickness and preventable death each year just because they are poor.