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Sweetening a Bitter Pill: Of Drug Prices, Drug Delays and Data Exclusivity

Spina Alì, GabrieleSweetening a Bitter Pill: Of Drug Prices, Drug Delays and Data Exclusivity Asia-Pacific Journal of Health Law and Ethics 12, 2 (2019), 1 - 51.

Commentators and social activists vehemently demonize data exclusivity for increasing the price of essential pharmaceuticals beyond the purchasing power of developing countries' citizens, whereas R&D industries defend it as a necessary instrument for bringing new medicines into the market. The present work adds to the ongoing debate by addressing the topic under the light of the empirical evidence
suggesting that low-income countries significantly lag behind Western economies in the introduction of new drugs. Under a policy perspective, the paper reviews in a unitary and comprehensive framework the stance that data exclusivity has a role to play in reducing the international drug lag in developing
countries. This paper concludes that empirical evidence does not offer compelling arguments to either uphold or discard drug lag driven data exclusivity claims and there is no room to advocate for data exclusivity as a generalized solution to the international drug lag. In spite of this, developing countries tend to give in to the pressures of their western counterparts and have already accepted data exclusivity
in more than 30 bilateral and multilateral free trade agreements. As such, anytime data exclusivity is accepted as a bargaining chip to strike a more favourable trade deal, a health-oriented precautionary approach demands to safeguard those flexibilities that are best fit to strike a balance between intellectual property, affordable medicines and prompt drug introductions. The paper will, therefore,
analyse and defend the consistency of six data exclusivity flexibilities with the international intellectual property regime and in particular with the TRIPS Agreement. In doing so, the paper provides developing countries' governments with some legal and policy arguments in support of data exclusivity
flexibilities, with the goal of best protecting the health interests of their populations in the process of implementation and/or negotiation of international data exclusivity provisions.