Recently, the United States and 11 other nations finished final negotiations for the Trans-Pacific Partnership (TPP) Agreement, the proposed trade pact that stands to influence nearly 40 percent of the world’s global trade. The agreement has been marred by disagreement, with congressional representatives, presidential candidates and corporations voicing their perspective on the treaty. Further adding to the drama, WikiLeaks has published what it believes to be the full text of the chapter on intellectual property including exclusivity for biologic drugs, prompting speculation on the impact of the stated provisions on intellectual property and biosimilars adoption.
While such disclosures avow to the authenticity of their information, many of the specifics of the agreement as relating to the exclusivity period for biologics are at best still vague. It is unknown to what extent this mirrors the final language in the agreement. It will be essential to understand if the nature of “exclusivity,” (data or marketing), transition periods for countries which have different or no exclusivity, and the context of “other measures”. Hence, the agreement could significantly increase patient access and drive innovation – a fair compromise – or, the agreement could reduce access through the delay of biosimilar introduction in member countries.
As has been noted by many, the TPP has the potential to modify regulations and alter tariffs across industries, including biopharmaceuticals. Most concerning within this rubric is access to biosimilars – biologic drugs deemed, in the language of the Food and Drug Administration (FDA), as without clinically meaningful differences to a reference product. While a biosimilars market has existed in geographies such as Europe and Australia as well as other Asian-Pacific countries for years, the United States only established regulations for biosimilars in 2010. It is clear, given the experience within other countries, the importance of these therapies in decreasing healthcare costs for all stakeholders, as documented in those regions where biosimilars have been adopted. If the TPP Agreement creates longer periods of exclusivity for biologics, it will put out of reach such medications for millions of patients in the region.
Without question, the development and manufacturing of biologics is costly. However, finding solutions to address these costs to a diverse set of populations and patients is not to reward ongoing monopolistic environments, by devices such as expanded exclusivity periods, but by rewarding innovation. Biosimilars represent copies of reference products without clinically meaningful differences for patients; however, the bioanalytical science and the manufacturing systems upon which this is based have taken years of research and development, with significant invested resources. Biosimilars are a disruptive innovation which provide competition and lowers prices. These lower costs translate to greater access, which saves patient lives and relieves suffering. The TPP Agreement, with the caveats on finality of language noted, may impact countries with and without healthy payer systems, minimizing patient access and effectively prohibit availability to important specialty medications.
Rather than reinforcing monolithic industries, legislators and policymakers must encourage marketplace competition, putting patient access first for the 800 million people in the countries under which the TPP Agreement applies. As Congress looks towards and eventual vote and potential affirmation of the agreement, they must consider the full impact of the TPP Agreement upon all global stakeholders, supporting regulations that avoid protectionism, and rather drive innovation.
Dr. Bert Liang is the founding and current CEO of Pfenex Inc., a biologics company focused on the development of biodefense products and providing access to biosimilars. Dr. Liang acts as the Chair of the Biodefense Policy Advisory Committee of BIO, and was recently elected inaugural Chair of the Biosimilars Council, a division of the Generic Pharmaceuticals Association.