Suspend E.I. 2023 restricting import of 142 medicines – PIWA, GNCoP to MoH

The Pharmaceutical Importers and Wholesalers Association of Ghana (PIWA), together with Ghana National Chamber of Pharmacy (GNCoP), is calling on the Ministry of Health (MoH) to immediately suspend the impending Executive Instrument (E.I.) 2023 on the Restriction of Medicines from Importation.

According to PIWA and GNCoP, the new E.I. seeks to restrict an additional 142 Products in three Schedules. This when passed in haste will potentially put in jeopardy the country’s healthcare system.

The association believes there should be further engagements with key stakeholders, including parliamentarians, policymakers, service providers, manufacturers, regulators and importers, among others, on the scope and timelines envisaged under the instrument.

In a joint press briefing, Executive Secretary-PIWA, Fiifi Yamoah, stated that despite the initial products being restricted from importation years ago, local manufacturers have still not been able to cater for them.

“It will be recalled that historically the first restriction on importation of medicines for local-manufacture only happened a few years ago with 27 Products. Subsequently in 2016, pursuant to E.I. 181, the importation of 49 Products were again restricted for local manufacture. The New E.I. seeks to restrict, at a go, an additional 142 Products in three Schedules.

“Such a huge increase will undoubtedly have serious ramifications on the country’s health sector. Prior to the drafting of this E.I. 2023, the Pharmaceutical Manufacturers Association of Ghana (PMAG) submitted a list of 116 pharmaceutical products to the Ministry of Health for consideration.

“The ministry thereafter forwarded the said list to the Food and Drugs Authority for their indispensable technical expert comments and recommendations. Of the initial 116 products submitted to the FDA, the Authority recommended only 38 products for restriction from imports and for local manufacture only,” Mr. Yamoah stated.

This move has raised significant questions about integrity of the list and its implications for local manufacturers after the MoH failed to comply with directions and advice from the FDA.

Concerns

PIWA and GNCoP’s serious concerns are with the subsequent changes to the list since the process began. According to them, all products added after the initial 116 were done arbitrarily without being subjected to regulatory review and standards by the FDA.

Again, they believe sensitive issues such as a medication import ban list- if allowed to be arbitrarily generated in such a manner as has been done previously – can undoubtedly result in serious consequences such as price hikes, medicine shortages, among others.

Capacity of Local Manufacturers

PIWA stated during the briefing that there is a clear absence of data to support the capacity of local manufacturers to meet the nation’s pharmaceutical needs in the immediate- and short-term if this E.I. is passed immediately.

PIWA added that: “There is even no data to confirm this capacity for the products under the previous E.I. 181. This is a glaring fact from the Ministry of Health’s own reports on the Framework Contract 1 and 2 statistics. Save a maximum of two local pharmaceutical manufacturing facilities in Ghana, none of the remaining local manufacturers have demonstrated an ability to meet their contractual obligations to the full as far as awards to supply under MoH, Ghana Health Service tenders are concerned.

“In fact, nearly all the local manufacturers are well-known importers of many finished products on the market. Even with their own customer demands, they have to fall on imports as they are not able to produce enough for their own demands.”

Recommendations from PIWA

Timelines for restricting certain pharmaceutical products should be adjusted to allow for critical national interventions. These include setting up a system for collecting data on local manufacturers’ capacity to meet national needs of medicines restricted under E.I. 181.

Again, there should be an establishment of effective support infrastructure – like contract manufacturing plants in three locations – to reduce the barriers in local manufacturing and limit restrictions to the 38 FDA-recommended products with regulatory support.