By Goldis Chami and Rebecca Goulding
Imagine you are dying from an infectious disease. An expensive, patented, life-saving medication is available only to those who can afford it, but since you happen to live in a developing country, neither you nor your local health-care authorities have the money to pay for it.
Today, hundreds of millions of people are in this position, having contracted treatable illnesses such as HIV/AIDS, tuberculosis, and other neglected diseases, yet lacking access to medicines that will cure them. A solution to the problem is relatively straightforward and within reach, and currently rests in the hands of Canadian politicians.
In 2004, Canada enacted legislation that allows for greater access to life-saving medicines for people in low- and middle-income (LMI) countries. Canada’s Access to Medicines Regime (CAMR) permits generic drug companies based in Canada to obtain a “compulsory licence”, which allows them to produce on-patent, essential medicines for export to LMI countries. Although CAMR has great potential to impact the health of the poorest people in the world, it is too complicated to be of interest to generic companies, and needs a number of amendments so that its promise can be realized.
University researchers perform much of the initial basic science research that leads to the development of medications. Biotech and pharmaceutical companies pick up where universities leave off, investing a great deal of money into research and development to bring a drug to consumers.
Given the financial risks associated with drug development, it makes sense that pharmaceutical companies are allowed to recoup their investment. Currently, companies recover their investment costs by patenting their technologies. Patents grant the patent owner the exclusive right to use and distribute an invention for a fixed period of time. Patented medicines are then sold at high prices to guarantee a profit. In 2004, the five leading drug companies in the U.S. had a median profit of 16 percent of their sales, which represents exceptional profits compared to other top industries.
High drug prices aren’t as serious a problem in high-income countries because our health-care systems are relatively well funded and tend to subsidize the cost of medicines. However in LMI countries, high medicine prices are entirely prohibitive to health care because governments can’t afford to subsidize them.
Part of the solution to the price problem is to allow for generic production of essential medicines. Internationally, drug patent rights are protected by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement of 1995. In 2001, a follow-on agreement called the Doha Declaration allowed low-income countries to obtain compulsory licenses to generate generic versions of essential medicines. However, most countries don’t have the capability to manufacture drugs themselves. Therefore the TRIPS agreement also encourages high-income countries to implement CAMR-like legislation, thereby allowing the medicines to be manufactured in wealthy nations such as Canada for export to LMI countries. In enacting the CAMR legislation, Canada was the first country in the world to take this important step.
Under CAMR, brand-name pharmaceutical companies could still make a profit selling medicines to high-income countries (where they currently make most of their profits), while simultaneously allowing generic producers to manufacture copies, thus ensuring access to cheaper versions of medicines in low- and middle-income countries. But while CAMR was passed into legislation in 2004, the first shipment of drugs manufactured under this law only went out in October 2008. Canadian generic drug company Apotex shipped seven million tablets of Apo-TriAvir, a triple combination HIV/AIDS drug, to Rwanda. The selling price was about one-third of what it would have been if the brand-name drugs were each purchased separately. Apotex was able to obtain a licence to produce and export the equivalent of a one-year course of treatment for approximately 21,000 people.
But it is possible that this shipment will be one of the only of its kind made under the CAMR. Why? Because the generic company has to file a licence application for every drug, for every amount of drug produced, and for every country that it wants to export to. Further, the list of drugs that generic companies can produce for export is narrow. Norway, India, the European Union, and China have also enacted CAMR-like legislation, and are experiencing similar issues.
Proponents of the current legislation maintain that strict controls are needed to ensure that generic versions of medicines are not re-imported back into wealthy countries, such as Canada, where the patents remain in force. But there is no evidence that re-importation exists as a significant issue especially in light of the significant public-health impact that generic medicines could have in LMI countries.
Bills have been put through the Senate and the House of Commons, reflecting many of the reforms that need to be made. These amendments will greatly simplify access to Canadian-made generics, and may well serve as a model for other countries with similar legislative roadblocks. Canadian politicians need to recognize the global health significance of CAMR and amend it. Because no one should be dying from a treatable illness, no matter where they live in the world.
Goldis Chami and Rebecca Goulding work with the Open Health Initiative housed at the Centre for Sustainability and Social Innovation at the University of British Columbia. They are also members of Universities Allied for Essential Medicines, an organization that works to ensure that biomedical end products, such as drugs, developed in campus labs are made accessible and affordable in low- and middle-income countries. Goulding is also a postdoctoral fellow with the Intellectual Property Policy and Research Group based out of the W. Maurice Young Centre for Applied Ethics at UBC.