The Pharmaceutical Regulatory Authority is established under the Pharmaceutical Act (No.14) of 2004 as a body corporate with perpetual succession and a common seal and capable of suing and being sued in its corporate name. PRA is made up of the Board and the Secretariat. The Authority is responsible for regulating and monitoring the entire pharmaceutical industry in Zambia and the movement of pharmaceutical products throughout the distribution chain.
The main objective of the PRA is to ensure that all medicines and allied substances conform to the required standards for quality, safety and efficacy throughout the chain of manufacture, importation, exportation, distribution, storage and supply and that the drug information is accurate and conform to the required standard and that only appropriately qualified persons carry out relevant pharmaceutical practices.
Solution
Generally, Developed countries should take this issue into account as the crucial issue. It can endanger the developed countries citizens indirectly. As the globalization emerges, people can travel around the world, across the boundaries, including Zambian people. HIV/AIDS, TBC, and any others dangerous diseases can be transferred easily as the consequence of globalization. If the developed countries still stick to their stand point, sooner or later, its citizens can be suffered as well. There are two solutions that can be offered by Zambia on this issue:
Subsidy from the developed countries
Developed countries which are also the countries which produce the patented medicines are suggested to give subsidies to the least-developed countries in order to create the inexpensive medicines and affordable to its citizens. Subsidies can be the reduction of price, and give price to the LDCs the price which constructed with the production cost only, no royalty fee, distribution fee, and no profit at all.
Compulsory license policy
Developed countries are suggested to give compulsory license to the third party to create generic medicines which is cheaper than the patented one. The third party also suggested to be bonded with the rules that prohibit them to reap much profit from this business opportunity. This agreement prohibits the third party to put the brand name in the medicine packages to avoid the dumping politic. Beside that, these medicines cannot be sold in the home country and developed countries in order to give the market share to the patented medicines, but also to secure the health of the developed countries citizens. In the other word, these generic medicines are only for export to the least-developed and developing countries.
