Factors Encouraging the Distribution of Counterfeit Drugs
We already know counterfeiting drugs is illegal. The question is: why does this continue? The Peterson Group had asked members of Drug and Food Administration (DFA) to understand the agenda behind these kinds of fraudulent acts.
Lack of political will and commitment
The development, manufacture, import, subsequent handling within the distribution chain and use require specialized knowledge and skills. Consequently, they should conform to prescribed standards and their quality should be rigorously controlled. However, this would require strong government will and commitment to establish and operate а strong national drug regulatory authority.
Lack of appropriate drug legislation
According to major reviews, legislation and regulations form the basis for drug regulation. Where legislation and regulations do not exist for proper control of medicines, the otherwise criminal activity of counterfeiting of medicines is not treated as а crime. Currently, only а few of the WHO member states have enacted special national legislation addressing the issue of counterfeit drugs. Moreover, sanctions imposed on counterfeiters are in most cases no deterrent. The absence of deterrent legislation encourages counterfeiters since there is no fear of being apprehended and prosecuted.
Absence of or weak drug regulation
At present, out of the 191 WHO member states about 20% are known to have well developed drug regulation. Of the remaining member states, about 50% implement drug regulation at varying levels of development and operational capacity. The remaining 30% either have no drug regulation in place or а very limited capacity that hardly functions. In developing cities such as New Delhi, India, Jakarta, Indonesia and Kuala Lumpur, Malaysia, laws for counterfeited medicines are still under process.
Weak enforcement and penal sanctions
Enacting deterrent anti-counterfeiting legislation alone will not solve the problem. It needs to be enforced. Where existing laws are not enforced crime is perpetuated as criminals are not afraid of being arrested and prosecuted. Lenient punishments for offences tend to encourage criminal activities such as medicines’ counterfeiting, particularly when the penalties for counterfeiting non-medicinal products are more severe. Moreover, disregarding trademark rights may encourage large scale counterfeiting of drugs.
Corruption and conflict of interest
Corruption is one of the major factors that affect the entry of counterfeited medicines in countries. Big manufacturers of these drugs have connections involving political corruption that lets these scammers in and out of the country. The efficiency of personnel is adversely affected by corruption and conflict of interest resulting in laws not being enforced and criminals not being arrested, prosecuted and convicted for their crimes. Governments need to develop strategies to reduce corruption. One approach could be to empower public interest and consumer groups to participate in drug regulation and to make regulatory authorities accountable and their decisions transparent.