ENFORCEMENT OF LAWS AND REGULATIONS

Intellectual Property Rights (IPR) violations are a serious cost to any research based pharmaceutical industry; it can also lead to issues such as counterfeiting and production of sub-standard drugs. A research molecule is protected by a patent. This patent has to be respected in order for innovative companies to keep research and development of life saving drugs. In Pakistan, both IPR and Data Exclusivity are relatively newer concepts but with the establishment of a robust IPR regime and the Intellectual Property Organisation of Pakistan, it is hoped that IPR infringements will be addressed in a more serious manner.

Pakistan is lacking in proper enforcement of this law and proper functioning of Intellectual Property Organization. Until the expiry of patents, according to TRIPS, Originator Brand has the exclusive rights to market a particular patented product. Any drugs registered of another company for generics are in violation of international law.

Generics are being registered based on the documents produced by the Originator Brands. They should be tested for impurities to assess their side effects on human health. If the results show that the impurities are harmless then dissolution tests should be conducted. After it passes the dissolution testing, Bio Equivalence Study has to be conducted to evaluate whether a Generic has the same standards of efficacy and safety as compared to the Originator Brand. Government must establish centers to conduct such studies that are reliable and have international recognition.

Punjab Government has recently started to test pharmaceutical products from the market on a sample basis by sending them to local labs and some to labs in the UK.

Before issuing license to any company, laws require that there should be stringent and thorough checks whether the manufacturing facilities are compliant with the current Good Manufacturing Practices (cGMP) and current Good Packaging Practices (cGPP). Certain small-scale manufacturers do not follow best practices of Health, Safety and Environment that a Multi-National or a large local company has to follow. This creates differences in the costs of production that are not considered when determining prices in Pakistan.