Right time, right place, right medicine:
why functioning regulatory systems are the bedrock of access to medicine

Despite global consensus that access to pharmaceuticals as a lifesaving commodity is a fundamental human right, 2 billion people globally still lack access to medicines. Ensuring access to the right medicine for the right patient in the right place at the right time is a complex feat that requires a multifaceted approach. That said, we cannot achieve universal health coverage without overcoming the challenges and assuring access to medicines for all.

Today marks the first World Patient Safety Day, an annual moment to increase awareness and engagement and to foster global concerted action to enhance patient safety. While patient safety is implicated at every step of the healthcare continuum of care, unsafe pharmaceutical practices and medication errors are the leading cause of injury and avoidable harm in health care systems across the world.

Notwithstanding the complexity of this issue, the concept of strengthening national and regional regulatory systems as the foundation to achieving timely access to quality medicines and vaccines is often not given due attention. Functioning national regulatory authorities ensure that pharmaceutical and biological products released for public use are evaluated properly and meet international standards of quality and safety. In low- and middle-income countries (LMICs), national regulatory authorities are typically characterised by reduced technical expertise, shortage of qualified staff, limited resources, inadequate infrastructure and suboptimal regulatory processes. When considering the pharmaceutical value chain, several hurdles that act as barriers to access can be rooted in poor regulatory oversight.

Why are weak regulatory systems problematic?

Immature or poor regulatory systems affect the pharmaceutical industry, governments, health systems and, ultimately, patients on the ground. Pharmaceutical companies require functioning regulatory systems to operate in any jurisdiction. Before a pharmaceutical product can be sold in a country, it must be registered with the national regulatory agency. However due to technical and capacity constraints, national regulatory systems in LMICs often have lengthy processing times. This has hindered access to new, innovative medicines as large research-based pharmaceutical companies avoid or delay launching their new products in these countries. This delay in access can range from 4 to 7 years after the medicines are first made available in high-income countries.

A lack of regulatory oversight results in falsified and substandard or fake medicines making their way into local pharmacies and hospitals. The WHO estimates that 1 in 10 medicines in LMICs are affected, potentially leading to significant patient harm. Naturally this creates distrust in locally produced or imported non-branded medicines. The impact of this is twofold. First, it results in serious affordability issues as patients opt to purchase higher priced branded versions of the medicine due to their perceived higher quality. Bearing in mind most people buy their medicine out of their own pockets, this will continue to push more families and vulnerable people into poverty.  Second, this distrust undermines health systems’ cost-containment measures of maximising the use of generic medicines – which means less money left in the pot to purchase higher cost, newer patented medicines. The global counterfeit market is estimated to be worth $200 billion annually, which represents a grave waste of resources and increases the strains on already stretched healthcare budgets. Health systems and patients incur extra costs from having to buy medicines a second time when the fakes don’t work or from having to cover the cost of treatment of ill health caused by the fake pharmaceutical products itself.

Factors contributing to the growth in substandard and falsified medicines

* substandard and falsified. Source: WHO Global Surveillance and Monitoring System for substandard and falsified medical products. Geneva: World Health Organization, 2017

Restoring faith in the quality of pharmaceuticals in LMICs  

Governments must prioritise investments in strengthening national regulatory systems and increase cross-country collaboration to strengthen regional and global regulatory networks and systems. This investment will have positive spill-over effects in fostering a strong domestic pharmaceutical landscape. LMICs can look to engage the World Health Organization’s capacity-building initiatives and technical assistance to ensure national regulatory authorities reach a level of maturity that enables a stable, well-functioning integrated system of oversight for medicinal products.

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