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Article 58: a hidden potential

In 2004, the EMA introduced the Article 58 procedure to help increase access to medicines by low- and middle-income countries and to improve public health. Article 58 was borne from a collaboration with the World Health Organisation (WHO) to get much needed medicines such as vaccines to those countries in most need. 

Over the years, the EMA has put in place a range of regulatory tools to support applicants in the development and submission of applications for medicinal products relevant to Article 58.  Since its inception the EMA has thus far given positive opinion on seven products via the Article 58 route, mainly in the area of infections and vaccines.   Just last year, a report was published by the EMA on its first decade of experience with the procedure, noting that success has been somewhat limited.    "These seven products have experienced mixed commercial success in the LMICs' post-opinion," the report concludes.   "While over 60% of these products have been hampered by poor [national regulatory authority] NRA recognition of Article 58 opinions, most of the products with positive opinion from Article 58 have suffered from poor commercial viability, unrelated to the regulatory pathway."

As a result of this review, the EMA is clarifying the avenues through which companies can gain support in relation to utilising this procedure of registration.   Initially, the EMA is recommending companies to seek out formal scientific advice during the development phase of the molecule, thus helping to smooth the pathway towards registration on all aspects of the process.   The agency also notes that experts from WHO and national regulators may be brought into the scientific advice procedure.  The EMA is also encouraging companies to request business pipeline meetings with the agency.   During these meetings, the EMA says that companies have the opportunity to discuss their pipelines with "a restricted group of senior agency staff" to identify areas where the company may need guidance down the road.  Additionally, the EMA clarifies that Article 58 applications are also eligible for the agency's tools for speeding access to new treatments, including accelerated assessment, conditional scientific opinions, and scientific opinions under exceptional circumstances.

The current landscape regarding access to essential medicines in the developing world is constantly changing and ELC Group is best placed to help companies maximise the use of these procedures, as well as development and submission strategies.


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