This section focuses on licensing activities, unlicensed illegal facilities, problems related to legal structures and implementation problems.

6.4.1 Licensing activities

Licensing-related activities include the issuing, renewal, suspension and revocation of licences. These can be considered as outputs of the licensing system. Measuring outputs is the fundamental and least complicated aspect of evaluating policy and performance of an organization. However, data for the various licensing activities carried out between 1994 and 1997 are not always readily available or accessible. Even when they do exist, they may have been compiled using different systems of categorization, making comparison across countries difficult. For example, the Australian TGA has a good data system for licensing of manufacturing, but licences are grouped under a product-type system, rather than an establishment-type system, as in most of the other countries. In Malaysia, the list of licensed manufacturers, importers and wholesalers of registered products is available on the DRA’s website. However, the website does not give the profiles of premises whose licences have been revoked.

In some countries data on licensing is not centrally available.

6.4.2 Unlicensed/illegal establishments

Another means of evaluating policy and organization performance is by measuring actual outputs against expected outputs. When asked whether unlicensed drug establishments and persons had been detected in their countries, five of the 10 countries responded that they had indeed detected such establishments and persons, but were unsure of their actual numbers.

For Malaysia, the official records indicate that there are no unlicensed establishments engaged in the pharmaceutical trade. However, the Malaysian Organization of Pharmaceutical Industries believes that this is not, in fact, the case. In Australia, Cyprus, Estonia, the Netherlands, Tunisia, Uganda and Venezuela, the great majority of - if not all - manufacturers, importers, wholesalers and retailers are licensed. However, unlicensed persons engaged in the pharmaceutical trade have been detected in most of these countries. In Australia and the Netherlands, their numbers are reported to be small, but in Uganda and Venezuela the numbers are much larger. In Cuba in 1998, only 25 out of 54 manufacturing laboratories had a licence, although this does not mean that the others were necessarily illegal establishments.

6.4.3 Problems related to legal structures

The studies revealed that problems in licensing pharmaceutical establishments can be grouped into those relating to legal structures and those relating to implementation.

The absence of mandatory manufacturer licensing in Cyprus is believed to be a factor in the establishment of small packaging units to bypass price-fixing procedures. Moreover, the procedure for issuing a licence to manufacture a product is, to a certain degree, retrospective, since the application is submitted after the manufacturer has built the facility. Ensuring that any requested modification of the facility is carried out is therefore difficult.

Another problem arises from the way in which the laws grant different responsibilities to different authorities, leading to coordination problems. In Cyprus, the licensing body for manufacturing and marketing is the Drug Council, which is an independent body with the DCQSS as its secretariat. The same body is responsible for GMP inspection. But inspections of distribution channels are undertaken by another department of the Pharmaceutical Services Division - the Inspectorate Sector - which is not related to the Drug Council. To make matters even more complex, the authority to issue licences to pharmacists and pharmacies rests with the Pharmacy Board, which is a consultative board to the Minister of Health.

In Zimbabwe, the employment of unlicensed pharmaceutical sales representatives by some importing companies can perhaps be attributed to the fact that no import permit is required for importing registered drug products. Therefore, once a company registers a product, any other company can also import and distribute that product using unregistered sales representatives.

6.4.4 Implementation problems

As shown in Chapter 4, the fact that laws exist to regulate a pharmaceutical function does not necessarily mean that they will be complied with, as can be seen in the following example from Uganda.

According to the law of Uganda, a medicine should never be dispensed in a retail pharmacy if the authorized person is absent. But given Uganda’s low number of qualified pharmacists, this requirement is not met anywhere in the country other than in the capital, Kampala. Moreover, many of Uganda’s drug shops, particularly those in rural areas, are neither licensed nor operated by medically trained personnel, and some drug shop premises are in poor condition.

More problems relate to the sale of drugs. Although Uganda’s wholesalers are required to sell drugs based on previously placed orders, wholesale pharmacies commonly operate like retail pharmacies, selling drugs to any purchaser at any time. Similarly, in spite of the fact that an import licence is required by law, a large number of drugs enter Uganda illegally.