E-DRUG: Industrial perceptions of medicines regulatory harmonization in the East African Community
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https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0218617
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Industrial perceptions of medicines regulatory harmonization in the East African Community
By Live Storehagen Dansie, Walter Denis Odoch, Christine Årdal
Abstract
Background: Medicines regulatory harmonization has been recommended as one
way to improve access to quality-assured medicines in low- and middle-income
countries. The rationale is that by lowering barriers to entry more
manufacturers will be enticed to enter the market, while the capacity at the
national medicines regulatory authorities is strengthened.
The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing
regional platforms with harmonized regulatory procedures for the
registration of medicines. The first region to implement medicines
regulatory harmonization was the East African Community (EAC). The
harmonization was based on the existing EAC Free Trade Agreement, which
officially launched the free movement of goods and services in 2010.
Methods and findings: In this study we conducted semi-structured interviews
and performed document reviews. The main target group for our interviews was
pharmaceutical companies. We interviewed 18 companies, including 64% of the
total companies who had experienced the EAC joint product assessment
procedure, and two EAC-based national medicines regulatory authorities. We
found that generally pharmaceutical companies are supportive of the
African-based MRH efforts and appreciative of the progress being achieved.
However, many companies are now hesitant to use the joint product assessment
procedure until efficiency improvements are made. Common frustrations were
the length of time to receive the actual marketing authorization;
unexpectedly higher quality standards than national procedures; and
challenges in getting all EAC countries to recognize EAC approvals. Smaller,
less attractive markets have not yet become more attractive from a corporate
perspective, and there is no free trade of pharmaceuticals in the EAC
region.
Conclusions: Pharmaceutical companies agree that medicines regulatory
harmonization is the way forward. However, regulatory medicines
harmonization must actually result in quicker access to the harmonized
markets for quality-assured medicines. At this time, improvements are
required to the current EAC processes to meet the vision of harmonization.
Christine Oline Årdal
Norwegian Institute of Public Health
Oslo, Norway
christine.ardal@fhi.no
www.fhi.no