New guidelines to boost sales of drugs made in East Africa

Local drug makers to get a bigger share of the region’s pharmaceutical market.

President Uhuru Kenyatta on a tour at CIPLA Quality Chemical Industry LTD by Company Pharmacist at their manufacturing plant in Kampala, Uganda. The biggest challenge for the region is the high cost of manufacturing drugs. FILE PHOTO | NATION 

IN SUMMARY

  • The regional manufacturing plan of action takes effect on January 15, 2018.
  • Currently, the region imports even basic products like sugar and starch used in pharmaceutical firms.
  • The challenge to the Action Plan is that there are still a number of differences between national regulations.

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Local drug makers will get a bigger share of the region’s pharmaceutical market after the Council of Ministers approved the East African Regional Manufacturing Plan of Action 2017-2027, under which national procurement agencies are required to buy at least half of their medicines locally.

The regional manufacturing plan of action takes effect on January 15, 2018.

The Council has also challenged the manufacturers to produce more advanced products such as delayed release formulations, small-volume injectables and double-layered tablets.
In this case, national procurement laws will have to be reviewed to accord companies from other member states local treatment for them to enjoy preference in the procurement.

Hurdles

However, raising the profile of pharmaceutical companies will take more than protectionism with intellectual property rights and funding expansion being key hurdles to the success of the move.

Nevin Bradford, the chief executive of Ugandan drug manufacturer Cipla Quality Chemical Industries Ltd (CiplaQCIL) said for East Africa to become a major player in the pharmaceutical sector, it has to start with partnerships with big pharmaceutical companies outside the region that have the technology, the people and the intellectual property.

“The biggest challenge for the region is the high cost of manufacturing drugs, including the price of the raw materials,” said Mr Bradford, adding that parallel importation and counterfeits is another challenge which partner states must address urgently.

He added: “The cost of medicines could be reduced by boosting local manufacturing through increased sector funding from governments. This is what happens in the developed countries.”

Collaboration

Currently, the region imports even basic products like sugar and starch used in pharmaceutical firms. Local sourcing will require collaboration among the key players in the pharmaceutical industries including national medical stores, regulators, manufacturers’ associations and manufacturers.

The pharmaceuticals Action Plan also supports the expansion of the EAC firms’ product portfolio to cater for more than 90 per cent of disease conditions.

The pharmaceutical companies will however have to capitalise on the available market ensuring that the medical products are safe, efficacious and of acceptable quality.

The Action Plan requires a single registration of medical products that are marketed in the five EAC member countries to avoid duplication of efforts, costs and time to the sector.

Partner states will have to harmonise verification levy/charges on pharmaceutical products originating from the region in accordance with the Common Market Protocol.

National regulations

However the challenge to the Action Plan is that there are still a number of differences between national regulations, and the region is currently testing the feasibility of a joint approval from all five countries’ drug regulatory agencies.

At the Council of Ministers meeting in Kampala last month, Kenya raised the concern that Uganda National Drug Authority recently increased the drug verification fee from two per cent to 12 per cent on 37 products, which increased the cost of supply of these products from the region.

It was also revealed that Tanzania charges 2.5 per cent, Kenya 0.75 per cent and Uganda two per cent on pharmaceutical imports into the country, which contravenes article 15 of the EAC Common Market Protocol which calls for non-discrimination of the EAC products. The meeting said the issue has to be addressed urgently by the countries’ ministries of health.

The EAC ministers in their report said that in addition to regional policy harmonisation, local pharmaceutical industries need a supportive domestic policy environment, including on tax, research and development, and trade policies.

Investments will be done under the single registration of medical products that are marketed in the five EAC member countries as required by the Medicines Regulatory Harmonisation scheme and the joint Harmonised Good Manufacturing Practice inspections to avoid duplication of efforts, costs and time to the sector.

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