Legal & Regulatory > Zimbabwe > Regulatory, Pricing and Reimbursement Overview: Zimbabwe

The key facts about regulatory, pricing and reimbursement overview in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The Medicines Control Authority of Zimbabwe (MCAZ) is the authority tasked with regulation of drugs and medical devices in Zimbabwe. It is established in accordance with the provisions of the Medicines and Allied Substances Control Act [Chapter 15:03] (hereinafter “the Act”).

It must be noted that only two medical devices (namely condoms and gloves) are currently regulated (under Statutory Instruments 183 of 2005 and 1 of 2016 respectively).

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

This is also governed in terms of the Medicines and Allied Substances Control Act. MCAZ authorises the manufacture, sale, registration and cancellation of registration of drugs. Dangerous drugs are governed in accordance with the provisions of the Dangerous Drugs Act [Chapter 15:02]. Authorisation to manufacture and sell drugs in terms of this Act is granted by the Minister on such terms and subject to such conditions, including, in the case of a license, the payment of a fee, as the Minister may fix.

There are however no regulations for the pricing and reimbursement of drugs, biological and medical devices in Zimbabwe. Drugs for the treatment of HIV and AIDs, malaria and tuberculosis are subsidised through grants and the payment of an AIDS levy by companies and individuals (Section 14(7) of the Finance Act [Chapter 23:04]) and are therefore more reasonably priced in Zimbabwe (see Schedule 2 – Limitations and Exclusions – National Social Security Authority Voluntary Informal Sectors Schemes Notice, 2018).

The lack of available foreign currency in Zimbabwe, together with high overhead costs, has, however, caused a sharp increase in the pricing of all drugs – both in the private and public sector (see Report to Parliament of Zimbabwe, dated 5 September 2019 – https://www.parlzim.gov.zw/national-assembly-hansard/download/2748_e5266 cde422c832cb75729a001cc16b9).

3. What are the steps to obtaining authorization to develop, test, and market a product?

3.1 Developing a Drug

To develop a product, the manufacturer must make an application, which is accompanied by a dossier of the product to the Medicines Control Authority of Zimbabwe (Section 68 of the Medicines and Allied Substances Control (General) Regulations, 1991, hereinafter “the Regulations” as read with Sections 30 and 38 of the Act). The dossier must include all information relating to the product. The Registration department will thereafter review the dossier to ensure that the manufacturing of the product complies with the World Health Organisation Good Manufacturing Practices (GMPs) as set out in the MCAZ Good Manufacturing Practice Guidelines. If the product is registrable in Zimbabwe, the MCAZ inspectors will thereafter inspect the manufacturing plant at the manufacturers cost.

3.2 Testing a Drug

MCAZ has an established laboratory for purposes of quality control testing. The laboratory is a functional part of the MCAZ and they do not contract the service elsewhere (Section 25A of the Act).

In accordance with Sections 16 to 21 of the Act as read with Section 100 of the Regulations, to test a product through clinical trials, a signed application in the prescribed form, seeking authorisation of the Authority must be submitted to the Director-General. Where the medicine is to be tested on human beings, their names and physical identification particulars must be included in the application. Where the trials are conducted on animals, the kind of animals will take part in the clinical trial, and the names and addresses of the owners must also be included in the application. If the trial is to be conducted in a hospital or other medical institution, the medical superintendent or a senior medical officer of comparable rank of such hospital or medical institution must countersign the application. The Director General will thereafter submit the application to MCAZ, which will consider the application and consult with the Secretary. Where the application is granted, the trial shall only commence where:

1. voluntary written consents of all adult persons, taking part in the clinical trial have been freely obtained; and
2. in the case of a medicine for the treatment, the voluntary written consents of parents or legal guardians, as the case may be, of minors or persons under legal disability have been freely obtained; and
3. the voluntary written consents of the owners of all animals taking part in the clinical trial have been freely obtained; by the person conducting the trial.

3.3 Marketing a Drug

Prior to marketing both human and animal medicines in Zimbabwe, registration and approval by MCAZ is compulsory (Sections 29 and 30 of the Act). The application for registration must be done by or on behalf of the principal medicine owner. The applications for registration of conventional medicines are made through completing a statutory application form and providing MCAZ with a dossier of supporting documents (Section 31 of the Act). A prescribed form must be completed and submitted to the Evaluations & Registration Division by the applicant. The division staff will complete the form and send it back to the client with appropriate fees for the service required. There are the three main types of medicine applications that require different application fees namely generic medicines, new chemical entities and line extensions. Applications may only be submitted after payment for the application has been made.

In relation to finished pharmaceutical products, the following is also required:

(i) a list the countries in which:

• the finished product has been granted a marketing authorisation;
• finished product has been withdrawn from the market; and
• an application for the marketing of the finished product has been rejected, deferred or withdrawn.

(ii) The details of registration in the country of origin are required. Reasons for non-registration should be stated if the medicine is not registered in the country of origin.

(iii) Registration status in the country of manufacture should be indicated including any withdrawal, cancellations, suspension / revocations. The reasons for these should also be indicated.

A finished product, in relation to a medicine, means a medicine, which is wholly manufactured outside Zimbabwe, is imported into Zimbabwe, and is ready for sale without have to be relabelled or repackaged.
Applications are thereafter screened and may only be evaluated after passing screening. Re submission is permissible after failed screening. An extra fee is payable.

4. What are the approximate fees for each authorization?

The fees are set out in the First Schedule of the Regulations and are as follows:

Application for a Registration of a Medicine

(a) in the case of a medicine imported into Zimbabwe as a finished product for:

1. a new chemical entity including dosage form or a delivery system (human) $3000.00
2. a new chemical entity including dosage form or a delivery system (veterinary) $2000.00
3. a generic medicine (human) $2500.00
4. a generic medicine (veterinary) $1500.00
5. a line extension of a medicine (human) $1500.00
6. a line extension of a medicine (veterinary) $1000.00
7. orphan medicine $750.00
8. a previously registered medicine $750.00
9. resubmission of an application $600.00

(b) in the case of a medicine imported into Zimbabwe and which is re-labelled or repacked before being sold as –

1. human medicine $1500.00
2. veterinary medicine $900.00
3. a previously registered medicine $750.00
4. resubmission of an application $600.00

(c) in any other case –

1. human medicine $900.00
2. veterinary medicine $600.00
3. a previously registered medicine $750.00
4. resubmission of an application $600.00

(d) In the case of expedited review of –

1. a new chemical entity $4 500.00
2. a generic medicine $4000.00
3. a line of extension of a medicine $3000.00

Application to Conduct a Clinical Trial of a Medicine

If funded by a local sponsor –

1. human medicine $2000.00
2. veterinary medicine $1000.00
3. sub-study $1000.00
4. operational research study $1000.00
5. observational study $200.00
6. any other case $100.00

If funded by a non-resident –

1. human medicine phase 1 study $5000.00
2. human medicine phase II study $4000.00
3. human medicine phase III study or phase IV study $3000.00
4. veterinary medicine $1000.00
5. in any other case $500.00
6. operational $1000.00
7. bioequivalence/bioavailability $500.00
8. observational $200.00
9. in any other case $200.00

Marketing

1. Generic Medicines (excluding 15% VAT) per product application 2500.00 [foreign] $900.00 [local]
2. New Chemical Entities (excluding VAT) per product application $3000.00
3. (Biological and biosimilar medicines are included under this group) Line extensions excluding VAT per product application $1500.00

Approval of Advertisements or Promotional Material

1. in the case of an imported medicine $50.00
2. in the case of a medicine imported which is re-labelled and repacked before being sold $50.00
3. in any other case $50.00

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Once a product is registered, it is published in a drug register. All licenses shall be valid for a period of 12 months (Section 11 of the Regulations). Thereafter, a yearly retention fee must be paid. The retention fee is paid for the permission to market a registered or approved product for one year and the fee is payable by 1 April each year (Section 35 of the Regulations). If this fee is not paid, registration will not be renewed (Section 34 of the Act).

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The Act and regulations do not distinguish between local manufacturers and foreign-owned manufacturers. Both local and international manufacturers are required to comply with Good Manufacturing Practices, which are published by the government.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

There is no specific regulation relating to combination products. Each item will have to comply with the regulations specific to the product.

8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Compliance is monitored and evaluated by MCAZ inspectors (Section 65 and 66 of the Act). The inspectors are permitted to inspect premises where pharmaceutical activities are performed. These inspections are also a pre-requisite for the licensing of private facilities. Where inspections are legal requirements, these are the same for public and private facilities. The following inspections are carried out on local entities that are inspected for Good Manufacturing Practices compliance:

• Local manufacturers – Every two years
• Private wholesalers – Once a year
• Retail distributors – Once a year
• Public pharmacies and stores – Once a year
• Pharmacies and dispensing points if health facilities – Once a year (MCAZ Good Manufacturing Practice Guidelines)

The U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements are more strict that those relating to Zimbabwe. The inspectorate recognises manufacturers under the jurisdiction of “well-resourced Regulatory authorities” in countries which include the European Union, USA, Australia, Canada and Japan.

9. What is the potential range of penalties for noncompliance?

For noncompliance with the Act, penalties range from a fine and or imprisonment for not more than five years (Section 67 of the Act).

10. Is there a national healthcare system? If so, how is it administered and funded?

There is no national healthcare system in Zimbabwe. There are, however, public hospitals which are subsidized by Government.

11. How does the government (or public) healthcare system function with private sector healthcare?

As there is no public healthcare system, this does not apply. There is very little overlap between public and private health care in so far as hospitals are concerned, but both public and private doctors fall under the same governing body (Medical and Dental Practitioners Council and Health Professions Authority) in accordance with the provisions of the Health Professions Act [Chapter 27:19].

12. Are prices of drugs and devices regulated and, if so, how?

There is no regulatory framework for the price of drugs and devices although some professional bodies have established policies in relation to the pricing of drugs as set out above in paragraph 2.

13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?

Patients pay for drugs and devices themselves. Many Zimbabweans are also members of a medical aid society, and will pay premiums towards the same. Health care, drugs and devises may therefore be subsidized by medical aid societies, with the patient being responsible for the payment of any shortfall.

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Medicines are dispensed by a licensed medical practitioner or pharmacist or any other person licensed by the Authority (Section 17 of the Regulations). Dispensers will ordinarily include their own charges on top of the base price for the drug and device, which shall be used as compensation for their services.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

The regulations with respect to dispensing is set out in the Medicines and Allied Substances Control Regulations. In terms of these regulations, every person who dispenses a prescription preparation shall ensure that the prescription is not dispensed more than once, unless the prescriber has directed otherwise and in such event, the prescriber’s lawful instructions shall be complied with. At the time of dispensing, or where a prescription preparation has been supplied, on the subsequent receipt of the prescription, there is noted on the prescription the name and address of the supplier and the date on which the prescription is dispensed.

A licensed pharmacist may also dispense drugs from a licensed premise (in accordance with the provisions of Sections 54 and 55 of the Act). The sale of medication without a license is a criminal offence.

In addition, no person must dispense medication for an area to which members of the public have access (Section 59 of the Medicine and Allied Substances Control Regulations, 1991 – hereinafter “the Regulations”).

Doctors and pharmacists will be held to the standard of an expert, and any failure to dispense drugs in a manner in which a reasonable doctor or pharmacist would be considered to be negligence, and could lead to disciplinary or criminal action.