‘Patents for 325 drugs to expire between 2012-19’

The expiry of patents for 325 biological drugs between the years 2012 and 2019 has emerged as a major challenge for the local pharmaceutical companies, but the patent rights’ expiry in the near future offers a lot of opportunities to the Pakistan pharma industry, said Pakistan Pharmaceutical Manufacturers Association (PPMA) Chairman Haroon Qasim.
He said this while addressing the participants of the first National Pharma Summit, which resolved to support the country’s universities and science and research centres engaged in bioequivalence studies, in a declaration adopted at the conclusion of the moot on Thursday. Reading out the resolution, Qasim said the expiry of patents will lead to an increase in demand for bioequivalence to replicate biotechnology products like biological drugs. “We will need bioequivalence studies that are globally accepted and comply with international standards,” he said.
“Branded generic opportunities should be availed,” he stressed, “the PPMA intends to sign a Memorandum of Understanding with Iran for collaboration and cooperation in the field of pharmaceutics as transfer of technology, which may be much more cost effective.” Moot participants also unanimously supported the proposal for early acceptance of International Conference on Harmonisation (ICH) guidelines, supporting the PPMA to go forward with its plan for pharmaceutical Research Advocacy Council with market oriented economists and technocrats to lobby for their implementation.
The participants were of the view that the judiciary also needs to be educated on the pharmacy-related laws. In view of the fact that the country has inadequate infrastructure and the highest infrastructure operating cost in the world, the participants resolved to support the government towards quality education and good governance.
Considering the health status of people, representatives of pharma industry resolved to contribute towards the preventive side, instead of concentrating on the curative side. It was also acknowledged that some companies in Pakistan were not meeting even local standards and there was a need to persuade every pharmaceutical company to undertake stability studies of their products.
The PPMA chairman pointed out that drug pricing was a real problem and in the present circumstances there was no chance of investment in quality assurance. “Since there is no policy; hence no strategic investment,” he said. “We must keep costs under control, only then we can compete and focus on core products and not on everything.”
Urging the pharmaceutical manufacturers to go for WHO qualification, he said that though it was a tough regulator, it opens vistas for newer avenues and markets for medicinal products of developing countries like Pakistan.
“One of the biggest challenges we face today is human resource development. National pharmaceutical industry has changed a lot but we still need to do a lot more and recognise the importance of human resource development as it is the people who make the difference. Acknowledging that they need to think globally, the moot participants said since there will be more cross-border trade and investment in the days to come, the country needs to adopt free-market orientation. “These days, geography and time zones do not matter and we have to be mindful of different cultures,” said the PPMA chairman.
He said National Bioethics Committee (NBC) Guidelines on Physicians’ interaction with pharma trade and industry has been approved by the federal health ministry and the document has also been dispatched to all stakeholders. He hoped that the documents once deciphered by pharma industry, medical institutions and professional specialty organisations will mark the beginning of checking unethical practices. The summit participants regretted that the country does not have any FDA approved drug manufacturing plants, and urged the government to revoke SRO 288 by way of which 17% GST was imposed on the import of plant machinery and equipment.
They demanded that the pharmaceutical industry be placed under the ‘zero-rated’ category and export retention of 100% proceeds be allowed in foreign currency. They urged the government to share mark-up cost on loans and allow investment adjustment against future taxes for putting up international standard manufacturing facilities targeting the pharmaceutical markets of the US, UK, Australia, Japan and also those in developing countries.