A/HRC/11/12 page 24 provision in the United States-South Korea FTA, would cost US$ 504.5 billion and a four-year extension would cost US$ 722.5 billion, consequently putting a strain on the national health insurance system in South Korea.86 2. Data exclusivity 78. Before a pharmaceutical company introduces a new medicine onto the market, it has to submit clinical test data to national drug regulatory authorities (DRA) to prove the medicine’s safety and efficacy. In many countries, a subsequent generic manufacturer who seeks approval to market the generic equivalent is not required to submit fresh clinical test data but can show that its medicine is bioequivalent to the medicine of the originator company. Relying on the clinical test data of the originator, the DRA can grant marketing approval to the subsequent version. This allows generic medicines to enter the market quickly. Data exclusivity prevents such reliance on the original clinical test data by the DRA for a number of years and requires generic producers to submit their own clinical test data. Such a replication requires generic producers to allocate time and money to prove what is “already known” and also raises ethical concerns of replicating trials on human populations. Data exclusivity deters and considerably delays the entry of generic medicines and can lead to the maintenance of high prices of medicines.87 79. Although developed countries proposed the inclusion of data exclusivity in TRIPS, it was not adopted.88 TRIPS does not require countries to provide data exclusivity. Where a national DRA requires the submission of undisclosed data for the registration of a medicine, TRIPS only requires countries to protect such data against “unfair commercial use” in case it relates to a “new chemical entity” and if the origination of such data involved a “considerable effort”.89 Countries can therefore determine how to protect such data. Reliance by the DRA on the clinical trial data of the originator company to approve a subsequent medicine does not amount to unfair commercial use.90 80. The requirement to impose data exclusivity features in several FTAs. For instance, the US-Morocco FTA provides for data exclusivity. In fact, it does not limit data exclusivity to a “new chemical entity”, which is known internationally, but mandates the protection of test data of any “new product” defined as one previously unapproved in that territory.91 86 The Hankyoreh, “U.S. FTA may cost drug industry $1.2 billion” (18 Oct 06). 87 See footnote 9 above, p. 125. 88 UNCTAD-ICTSD (2004), chapter 28 (Undisclosed Information), s.2.2 (Negotiating history), pp. 523-26. 89 TRIPS Agreement, article 39, para. 3. 90 Carlos Correa, Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement (Geneva, South Centre, 2002). 91 US-Morocco FTA, section 15.10.