The future of some 450 local pharmaceutical companies and at least 0.5 million direct employees of the industry are in jeopardy, as Ministry of Health is amending Drug Act in accordance with Trade Related Intellectual Property-Rights (TRIPS) under the agreement of WTO.
Well-placed sources in health department told Business Recorder on Friday that ministry of health has already prepared summary to implement data protection and making linkage of patent with registration of generic medicine. The sources said the ministry has sent the summary to law department for legal advice.
Defining the data protection, the sources said according to the agreement only those companies could sell their medicines, which invented the medicines and eventually these have the right to save their data. The sources said after implementation of this law no other company could manufacture this drug forever, which is against the basic laws of humanity.
Explaining the prevailing registration law in the country, they said the local pharmaceutical companies, when wanted to induce new generic drug, took international drugs data from any pharmacopoeia and get register the new drug with their new generic name.
After the amendment in Drug Act, the sources said, no local pharmaceutical company in Pakistan could get register their medicine, as not a signal company is conducting research for making new drug due to their limited budget and lack of government interest. The sources said although many western countries have signed the WTO, but some countries had bitterly opposed it, only to save the trading rights and providing employment to their peoples.
They said Russia, India, Brazil, Argentina, Thailand, Bangladesh and other countries have already opposed the DP and Patent linkage. The sources said the World Health Organisation (WHO) has already stated that DP and linkage between patent status and generic registration "will trade away the people's rights to have access to medicines" and "DP and Patent linkage requirement are going beyond the TRIPS agreement".
The source said in case of implementation of law, the local pharmaceutical companies that are manufacturing 47000 generic medicines would be deprived of their trading rights. On other hand the sources said the people of Pakistan would be deprived from local and cheap medicines, while country's exports of millions of dollars would be hurt.
Pointing out the other aspect of the situation, the sources said that only 26 multinational pharmaceutical companies were manufacturing the medicines in the country, which were not fulfilling the country needs. They added that among the companies two have already wind up their business from Pakistan and other were considering to do so.
"In such a situation the only way for patients to approach the drugs was importing medicines, which would further distract the depleting foreign exchange reserves and the already mounting trade deficit," they added. Regarding the amendments in the act, the sources said that health department is responsible for maintaining efficacy and safety of drug not for trademark or copyrights.
The sources said that according to law only IPO department is responsible to maintain copyright, trademarks and other legal right of companies. The sources said local pharmaceutical companies, which is growing 29 per cent annually mighty collapse in case the proposed law was enacted.