Trade Agreements and Direct-to-Consumer Advertising of Pharmaceuticals.

Deborah Gleeson,David B Menkes

doi:10.15171/ijhpm.2017.124

Abstract

There is growing international concern about the risks posed by direct-to-consumer advertising (DTCA) of prescription pharmaceuticals, including via the internet. Recent trade agreements negotiated by the United States, however, incorporate provisions that may constrain national regulation of DTCA. Some provisions explicitly mention DTCA; others enable foreign investors to seek compensation if new regulations are seen to harm their investments. These provisions may thus prevent countries from restricting DTCA or put them at risk of expensive legal action from companies seeking damages due to restrictions on advertising. While the most recent example, the Trans-Pacific Partnership Agreement (TPP), collapsed following US withdrawal in January 2017, early indications of the Trump Administration’s trade policy agenda signal an even more aggressive approach on the part of the United States in negotiating advantages for American businesses. Furthermore, the eleven remaining TPP countries may decide to proceed with the agreement in the absence of the United States, with most of the original text (including the provisions relevant to DTCA) intact.

Highlights

International trade agreements negotiated over the last two decades include many provisions affecting domestic health policy,[1] but their implications for direct-to-consumer advertising (DTCA) remain relatively unexplored
Why Direct-to-Consumer Advertising Is Contentious? DTCA of prescription pharmaceuticals is banned in most countries due to perceived deleterious effects on rational prescribing, pharmaceutical expenditure, and health outcomes
The United States, which hosts the headquarters for many of the world’s transnational pharmaceutical companies, sought to legalise DTCA via the internet through the clause15: “Each Party shall permit a pharmaceutical manufacturer to disseminate to health professionals and consumers through the manufacturer’s Internet site registered in the territory of the Party, and on other Internet sites registered in the territory of the Party linked to that site, truthful and not misleading information regarding its pharmaceuticals that are approved for sale in the Party’s territory as is permitted to be disseminated under the Party’s laws, regulations, and procedures, provided that the information includes a balance of risks and benefits and encompasses all indications for which the Party’s competent regulatory authorities have approved the marketing of the pharmaceuticals.”

Summary

Introduction

International trade agreements negotiated over the last two decades include many provisions affecting domestic health policy,[1] but their implications for direct-to-consumer advertising (DTCA) remain relatively unexplored.

Results

Conclusion