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In the US, biologics are protected from competition of biosimilars by market ex- clusivity for twelve years from the time they are granted marketing approval. 69 Data exclusivity prevents the regulator from accepting an application for marketing authori- zation from a generic producer; this regulatory measure is independent on the patent system. 70 Data exclusivity system works as following: when a generic manufacturer wants to register his generic version of a drug, he has to provide data showing that the product is a bioequivalent to the original drug. The regulator already has all the clinical data from the original producer. However, the data exclusivity system prevents the regulator from “referring to existing clinical data to approve registration of generic version.” 71 This form of protection prevents competition even after a patent of the original product expires. 72 The only way the generic manufacturer can obtain the nec- essary registration is to repeat all the necessary clinical trials. The biologics producers, who are represented for example by the Biotechnology Industry Organisation, pushed during the TPP negotiations for a twelve year 73 data exclusivity period. They argued that the term was a result of a lengthy debate and that it is the best balance that both stimulates research and provides biosimilars in a timely manner. 74 However, evidence suggests that neither the existence of patentability of biolog- ics nor the market encourage development of new drugs. 75 The US proposition for the prolonging of biologics protection was one of the most controversial and raised protests from the observers, especially due to fears that it would lead to increase costs of medicines and reduced access to them. 76 On the other hand, evidence from Japan and Canada showed that health expenditures did not increase after the introduction of longer biologicals protection. 77 Nevertheless, the fact that the countries did not spend more on biologics does not mean that the treatment was available for everyone who needed it – the reason for not increasing the expenditures might have been budgetary restrictions, making the expensive treatment available only for few patients. The fact is that the biologics are extremely expensive and their extensive protection delays access to more affordable biosimilars. Due to this fact, even the US have been considering 69 The Conversation supra note 144. 70 Generics supra note 141. 71 “Trading Away Health” Doctors Without Boarders (August 2012) online [Trading Away Health]. 72 The Conversation supra note 144. 73 An early proposition of the US was even more restrictive: fourteen years; ibid . 74 Dan Stanton, “TPP: Five years data protection for biologics in US-Asia trade deal,” BioPharma (5 October 2015) online . 75 The Conversation supra note 144. 76 “New Report Suggests RDP Does Not Increase Healthcase Expenditures,” Biotech Now online . 77 Ibid.

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