Pharmaceutical Regulation: Friend or Foe?

A new policy briefing from Innogen argues that while regulation may help to ensure safe medicines, it can also act as an undesirable barrier to market entry in low- and middle-income countries, which in turn impacts on development, health delivery and access to medicines.

Drawing on a pilot study carried out in India, Kenya and South Africa with funding from IKD, Standards and Their Role in Pharmaceutical Upgrading in Low- and Middle-Income Countries aims to contribute to clearer understandings on what standards are, which are mutable and which immutable, and whether they hinder or promote innovation, technological capability upgrading and the making of medicines in low- and middle-income countries.

Questions asked range from who sets the standards and in whose interests, to whether or not enough is being done to purse alternative, easier-to-sustain but equally effective standards for developing countries given their manufacturing capabilities and health system requirements.

The main finding of the authors – IKD members Julius Mugwagwa, Dinar Kale and Geoffrey Banda – is that while standards for the pharmaceutical industry are sometimes viewed as independent drivers of technological capability upgrading, the reality is far more complex. Standards change over time and are shaped by a complex mix of firms’ innovations, lobbying, procurement politics and market protection. Consequently, standards may both help to ensure safe and efficacious medicines, and also act as an undesirable barrier to market entry.

Read more on the Innogen website. Read Standards and Their Role in Pharmaceutical Upgrading in Low- and Middle-Income Countries.