Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds – statnews.com

Report on Pharmaceutical Accessibility and its Implications for Sustainable Development Goals

1.0 Executive Summary

A recent analysis published in JAMA Internal Medicine reveals a significant disparity between the locations of clinical trials for new medicines and the subsequent availability of these medicines. The findings raise critical questions regarding the ethical obligations of pharmaceutical companies and present substantial challenges to the achievement of the United Nations Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being) and SDG 10 (Reduced Inequalities).

2.0 Key Findings of the Study

The research reviewed 172 medicines approved by the U.S. Food and Drug Administration (FDA) that underwent testing between 2015 and 2018. The primary data points are as follows:

1. Scope of Trials: Clinical trials for the approved medicines were conducted in 89 different countries.
2. Accessibility in Trial Host Countries: Of the 144 drugs tested in countries outside the United States, only 34 (24%) were physically accessible to patients in those same countries post-approval.
3. Marketing Authorization vs. Access: Among 77 countries that publicly report marketing authorizations, a mere 11 (14%) provided patients with physical access to all the medicines that had been tested within their borders.

3.0 Implications for Sustainable Development Goals (SDGs)

The study’s conclusions highlight a direct conflict with the principles of global development and equity as outlined in the SDGs.

3.1 SDG 3: Good Health and Well-being

The lack of access to approved medicines in countries that hosted clinical trials directly undermines Target 3.8 of SDG 3, which aims to “achieve universal health coverage, including…access to safe, effective, quality and affordable essential medicines and vaccines for all.”

• Ethical Concerns: The practice of conducting trials on populations that do not subsequently gain access to the proven treatments creates a significant ethical dilemma, questioning the principle of beneficence in research.
• Health Equity: This disparity perpetuates global health inequities, where communities contribute to medical advancement without reaping the benefits, thereby hindering progress towards ensuring healthy lives for all.

3.2 SDG 10: Reduced Inequalities

The findings illustrate a clear inequality in the global pharmaceutical landscape, contributing to the gap between developed and developing nations.

• Exacerbating Disparities: By limiting access to innovative medicines in many trial-hosting nations, which are often lower-income countries, the current model reinforces and widens health and economic inequalities between and within countries.

3.3 SDG 17: Partnerships for the Goals

This issue points to a weakness in the global partnership for sustainable development, particularly between the private sector (pharmaceutical companies) and national governments.

• Need for Stronger Partnerships: Achieving global health goals requires ethical and equitable collaborations. The report suggests a need for revised frameworks that ensure pharmaceutical companies adhere to post-trial access responsibilities as a core component of their partnership with host countries.

SDGs Addressed in the Article

• SDG 3: Good Health and Well-being

  The article’s central theme is the lack of access to essential medicines, which is a fundamental component of ensuring healthy lives and promoting well-being for all at all ages. The finding that only 24% of medicines tested in countries outside the U.S. were physically accessible to patients in those same countries directly highlights a failure to provide for the health of these populations.

• SDG 10: Reduced Inequalities

  The study reveals a significant inequality in health outcomes and access to medical innovations. There is a clear disparity between countries where drugs are tested (often lower-income nations) and the country where they are approved (the U.S.). The fact that populations who participate in clinical trials do not get access to the resulting medicines demonstrates an inequality of outcome based on geographic location.

• SDG 17: Partnerships for the Goals

  The issue points to a breakdown in the ethical responsibilities within public-private partnerships. Pharmaceutical companies (private sector) partner with host countries (public sector and civil society) to conduct trials. The article raises concerns about whether these companies “are adhering to ethical standards,” suggesting that the partnership is not effective in delivering equitable benefits, a key principle of SDG 17.

Specific SDG Targets Identified

• Target 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.

  This target is directly relevant as the article focuses on the “access to… essential medicines” component. The statistic that only 34 of 144 medicines tested outside the U.S. were accessible in the host countries is a direct contradiction to the goal of ensuring access for all.

• Target 3.b: Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines…

  The article discusses medicines that have completed the research and development phase (clinical trials) but are not made accessible. This points to a failure in the second part of this target, which is to “provide access” to these medicines after they have been developed, particularly for the populations that contributed to the R&D process.

Indicators for Measuring Progress

• Proportion of medicines tested in a country that are physically accessible post-approval.

  The article provides a direct measurement for this indicator. It states that of the 144 drugs tested outside the U.S., “only 34 — or 24% — were physically accessible in those countries.” This percentage serves as a clear, quantifiable indicator of the access gap.

• Proportion of countries with full physical access to all medicines tested within their borders.

  The article implies this indicator by reporting on countries that have formal marketing authorizations. It notes that among 77 such countries, “patients in only 11 — or 14% — had physical access to all of the tested medicines.” This measures the comprehensiveness of access on a country-by-country basis.

Summary Table of SDGs, Targets, and Indicators

Source: statnews.com