The period of data protection allocated to research-based, innovative drug companies is a hotly debated topic in the pharmaceutical industry and beyond. This period of protection allows research-based, brand name drug companies to maintain a monopoly on the market for any particular drug for a specified duration. During the period of data protection, competing generic drug manufacturers are not permitted to compare their product to the innovative one for the purpose of obtaining their own regulatory approval.
In a recent federal court decision, Justice Leonard Mandamin upheld federal regulations (created under Canada's Food and Drug Act), which provides data protection for a period of up to 8.5 years. Research-based, innovative drug companies (represented in this litigation by Canada's Research-based Pharmaceutical Companies (CRPA) and Eli Lilly Canada Inc.), consider this ruling a major victory in that it will help to promote the creation, production and distribution of new and innovative drugs in Canada. They claim that the positive effects generated by this ruling will ultimately have the greatest impact on Canadian patients, who will apparently have greater access to a wider variety of innovative medications and vaccines. These companies also stress that a rigorous data protection regime in Canada is necessary to secure sufficient and lasting investment in R&D. It is entirely understandable that potential investors would be hesitant to get involved in a project where data protection is weak.
Conversely, the generic drug companies (represented in this litigation by the Canadian Generic Pharmaceutical Association (CGPA) and Apotex Inc.), argue that this ruling is an unfair one, the negative effects of which, will be felt most markedly by Canadian patients/consumers. Jim Keon, president of the CGPA claims that as a result of this ruling, "brand drug companies will continue to have monopoly rules that go beyond Canada's international trade obligations and beyond similar provisions in the United States." However, according to a recent article, it seems highly probable that the United States will be extending the period of data protection in the near future. In a 16-7 vote, the US Senate health committee cast their ballots in favour of a 12 year data protection period.
In my opinion, the most important thing to consider in this debate between research-based, innovative drug companies and their generic counterparts is the interest/well-being of patients/consumers of these drugs. On the one hand, it is important to maintain a financial incentive for brand-name drug companies to continue to research and innovate to ensure that patients are receiving the most highly developed, quality products as possible. On the other hand, if generic drug companies are removed from the equation, it will become progressively easier for brand-name pharmaceutical companies to monopolize their respective markets, eventually causing undue hardship on the consumers who depend on these drugs.