Data Exclusivity: Making the Case - Pharmaceutical Executive

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Data Exclusivity: Making the Case

Pharmaceutical Executive


DE can encourage R&D in developing countries. DE has become a topic of intense discussions when addressing access to medicines in developing countries; DE is seen as an insurmountable obstacle that keeps cheaper copies of brand name drugs off the market, which then results in higher prices paid for medicines.

A linchpin to the debate is TRIPS Article 39.3, which states that undisclosed data are subject to protection against unfair commercial use or disclosure. This period of DE (which is not defined in TRIPS but varies between five and 11 years among countries that provide DE) means that another company when applying for a marketing authorization for a generic medicine, may not directly or indirectly use or rely upon the data submitted by the innovator to prove safety and efficacy.

DE is often criticized as encouraging excessive profiteering but that assertion should be weighed against the growing cost and resource burden of conducting clinical trials, often across geographies and varied populations whose medical needs are often subsidized by the inventor even after a trial ends, making even larger capital investments necessary. It is becoming evident that only the largest companies can actually afford or take the risk to bring these medicines to market.



With regard to the TRIPS agreement and access to medicines, the 2001 Doha Declaration on TRIPS and Public Health, acknowledges that a balancing of interests (between private and public rights) is needed in order to accommodate access and innovation. It provides exceptions that countries can implement on the national level to address public health issues such as seeking voluntary licenses or compulsory licensing. This selective approach might be tried first before endorsing the wholesale dismemberment of DE rights. Another is access to medicines secured through corporate sponsored patient-access programs, which apply innovative strategies to make medicines accessible and affordable in resource constrained regions. This remains an important way for patients to obtain patented medicines.

Data exclusivity can promote R&D into personalized medicines. The pharmaceutical industry is in the process of re-inventing itself by rethinking how it has historically approached R&D. The continued investment of substantial sums by the industry into R&D for personalized medicines (PM), although in the short term may be more costly to the consumer, is expected in the long run to reduce costs; advanced technology may help to minimize time on R&D side. The good news is that PM will be targeted to patients that are genetically programmed to benefit to ensure the patient has the best and safest drug for them. Protecting and maximizing the right incentives for such important work will be paramount to the substantial investment made into PM. DE protects that repository of specific data that developers produced to show regulators how a target drug can work efficiently in the right patient; without such exclusivity, one wonders how fully the promise of PM can be realized.

The importance of DE to our innovation strategy. DE can be an important tool in our national innovation strategy that will continue to keep the United States relevant and globally competitive, and it is worrisome that anti-innovation forces are working to water down the value of DE in raising the critical early stage capital that is necessary for R&D into medicines. Truly breakthrough drugs that can cure or prevent chronic diseases, cancer, or other emerging diseases can potentially lower healthcare costs and keep our nation at the forefront of science. Policymakers should therefore maximize the benefits of DE by considering even enhanced periods of exclusivity for truly breakthrough drugs—perhaps given through the FDA, which grants marketing approval. It is important that we do not deter the incentives into R&D, if we want to remain a global leader in cutting edge medicines.

Lastly, DE can incentivize and encourage companies to disclose all of their trial information as it provide a much needed measure of certainty to the innovator.

Carol Ann Williams is Senior IP Policy Specialist for Pfizer Inc. She can be reached at (212) 573-1593.


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