Abstract
In Chaps. 5 and 6, I have discussed the impact of test data exclusivity on the availability of generic pharmaceuticals. However, some FTA test data exclusivity provisions may also restrict access to originator pharmaceuticals in an FTA party as well. In this chapter, I focus on this possibility. As shown in Chap. 5, test data exclusivity provisions in FTAs have become quite detailed and comprehensive over time. They not only prohibit reliance on test data submitted with pharmaceuticals containing new molecular entities but also test data from new clinical studies for new indications and line extensions. In addition, these provisions regulate another aspect of pharmaceutical approvals: prohibition of reliance on a foreign marketing approval or test data.
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Notes
- 1.
Meitinger (2005) at 136-7.
- 2.
See notes 56 and 59 in Chap. 2.
- 3.
Art 1711(7) NAFTA: ‘Where a Party relies on a marketing approval granted by another Party, the reasonable period of exclusive use of the data submitted in connection with obtaining the approval relied on shall begin with the date of the first marketing approval relied on.’
- 4.
The provision is silent regarding reliance on data submitted with the foreign marketing application. In practice, reliance on data submitted with the foreign application does not make much sense unless the foreign application is approved and granted in the foreign country. The approval or grant is an evidence for the approval authority of the subsequent country of the usefulness of the data.
- 5.
The respective provisions in these FTAs have identical language relating to this issue. See Art 15.10.2(c) Panama FTA, Art 16.10.2(c) Peru FTA and Art 16.10.2(c) Colombia FTA (‘Where a Party relies on a marketing approval granted by the other Party, and grants approval within six months of the filing of a complete application for marketing approval filed in the Party, the reasonable period of exclusive use of the data submitted in connection with obtaining the approval relied on shall begin with the date of the first marketing approval relied on.’)
- 6.
Art 14.9.1(b) Bahrain FTA and Art 15.9.1(b) Oman FTA.
- 7.
Art 15.10.1 Morocco FTA.
- 8.
See Art 4.22 Jordan-US FTA and footnote 11; Art 17.10.1(c) Australia-US FTA; Art 18.9.1(b) Korea-US FTA and Art 16.8.2 US-Singapore FTA.
- 9.
Last sentence, Art 15.10.1(b) CAFTA-DR (‘… In order to receive protection under this subparagraph, a Party may require that the person providing the information in the other territory seek approval in the territory of the Party within five years after obtaining marketing approval in the other territory.’)
- 10.
This is to highlight the impact of test data exclusivity only.
- 11.
However, in Guatemala, some generic pharmaceutical products were removed from the market when originator products were later filed and received test data exclusivity protection. See Sect. 2.3.2.
- 12.
A possible impact for the originator company can be that the market may shrink in B after some time because of patients’ deaths, in case of fatal ailments. There will be some patients who will be able to access the pharmaceutical from A in the grey market. But the prices of such pharmaceuticals will be quite high as well.
- 13.
This assumes that even after taking into account other factors like cost of filing and marketing etc, launching the originator product in countries A and B is profitable.
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Shaikh, O.H. (2016). Test Data Exclusivity in FTAs and Access to Originator Pharmaceuticals. In: Access to Medicine Versus Test Data Exclusivity. Munich Studies on Innovation and Competition, vol 4. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-49655-8_7
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