The globalization of medicines as a challenge for governments

Article type: Research Article

Authors: Valverde, Jose Luis

Affiliations: Chair Jean Monnet of EU Law, Granada, Spain. E-mail: jlvalver@ugr.es

Abstract: Health is a global concern. The need for a globalized response is evident in the pharmaceutical industry. Although pharmaceutical products are developed and marketed internationally, they are currently regulated only at national level. The pharmaceutical agencies regulate medical products in a globalized environment. However, national regulations can create significant barriers to pharmaceutical availability. We must formulate our laws with a global focus. The globalization of regulation weakens national sovereignty but empowers transnational epistemic networks. For this reasons the pharmaceutical agencies are involved in several bilateral and multilateral cooperation activities with international partners. International cooperation is a key area of work for the agencies. This process will benefit of advancement in global governance and progress toward supranationalism. The internationalization of the pharmaceutical industry, highly globalized, involves changes in policies, lifestyle and culture, and has altered drug research, production, and regulation.

Keywords: Pharmaceutical industry, globalization, regulations, ICH, governance, governments, pharmaceutical agencies, products liability, pharmaceuticals inspections

DOI: 10.3233/PPL-160429

Journal: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 19-29, 2016