Regulatory Impact Assessment Report on Medicines and Allied Substances (Marketing Authorization of Medicine) Regulations

PROBLEM STATEMENT

Zambia lacks a developed pharmaceutical manufacturing industry to supply locally made essential drugs. As of 2022, there were ten registered pharmaceutical manufacturing companies in Zambia, seven of which are undertaking full manufacturing while three were involved in the repackaging of finished pharmaceutical products. Of the seven companies undertaking full manufacturing, only four were active. These companies were mostly engaged in the manufacturing of generic small and large volume parenteral, oral solid dosage forms, liquid dosage forms, powders, external preparations and medical supplies. Data from the Zambia Medicines Regulatory Authority (ZAMRA) indicated that only 123 registered medicines were produced locally, out of over 8,154 medicines on their register as of June 2022. Therefore, it was, estimated that the local production of medicine represented between 10 to 15 percent of the demand for pharmaceuticals in Zambia. (Parliamentary Committee Report on Health and Community Services, 2022).

As a result the country has been relying on imported drugs.  The importation of pharmaceutical products has further resulted in the Government accumulating debt owed to players in the pharmaceutical sector for the provision of various goods and services. The resultant effect of this debt was the shortage of medicines and medical supplies in most public health facilities. The shortage of medicines had impacted the patients negatively as they bear the cost of accessing medicines and medical supplies from private pharmacies.

According to the United Nations COMTRADE database on international trade, Zambia’s import for pharmaceutical products was US$208,422,130 in 2019 and US$260,058,974 in 2020 as indicated in the table below:

This costly undertaking resulted in the Government accumulating debt of about K3 billion as of 31st January 2020, owed to players in the pharmaceutical sector for the provision of various goods and services.

The Zambia Pharmaceutical Business Forum attributes the failure to attract investments in the sector to a range of issues such as taxes on inputs into manufacturing process and other customs impediments. The Forum also attributes the problem to high regulatory fees under the Zambia Medicines Regulatory Authority. It is this later issue that this regulatory impact assessment focusses on.

The fees referred to are contained in the Medicines and Allied Substances (Marketing Authorization of Medicine) Regulations, Statutory Instrument No. 79 of 2019. The fees are reportedly too high and contribute to the already high cost of doing business for the pharmaceutical industry.  The fees are categorized as follows:

 Marketing Authorization

Amendment to Marketing Authorization

 Importation of Medicines & Allied substances (Import permit)

 Other fees

 Good Manufacturing Practices (GMP) fees

Comments are invited from stakeholders on this matter. Stakeholders may provide any other relvant information on why investments in pharmaceutical manufacturing have not been anywhere close to meeting domestic demand for medical supplies.