In the second part of its 2018 annual report, CPhI Worldwide,?the world?s largest pharma event taking place later this year in Madrid, Spain, Dilip Shah, CEO of Vision Consulting Group, and Bikash Chatterjee, President and Chief Science Officer at Pharmatech Associates review the impact of IPRs and trade agreements and regulatory divergence respectively, suggesting the implications of both could have profound impacts globally.

Patent restoration
Dilip Shah argues strongly in his paper that the global trend towards patent term restoration and extension will result in patients needing to wait an extra 5 or 10 years to access generic versions of medicines. In many cases Regional Comprehensive Economic Partnership (RCEP) texts seek to redefine the protection period to 20 years from the date of marketing approval.

?For example, ?Patent linkage? under Comprehensive and Progressive Trans-Pacific Partnership Agreement (CPTPP) will require companies to gain consent from patent holder prior to use of data in a (generic) marketing approval. CETA between the EU and Canada has similar patent restoration as does EU-Japan economic partnership agreement.? commented Shah.

However, Shah believes this may, in fact, result in longer term consequences for the industry with consumers and governments ultimately forcing a fundamental reform of how medicines are reimbursed. Over the course of the next 5-years, he forecasts that, based on savings from generics in the U.S. reported by Association for Accessible Medicines (AAM) healthcare costs could potentially rise globally by as much as $100bn.

Port Worthy
American Lung Association
Novasep PharmaZell Group

The implications for the patented pharma industry is that it is likely to come under sustained pressure in the medium term (5-10 years) to reduce prices.

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Bikash Chatterjee in his paper on ?regulatory philosophy divergence and innovation convergence in the next decade?, predicts China?s rate of advancement is still accelerating and that we can very quickly expect full harmonization with ICH standards. The net result will be that China?s overall standards will improve quickly and poor quality manufacturers will drop out of the market in the next two to three years.


China is issuing new guidelines at a feverish pace and will be harmonised with ICH very quickly. The result is that over the next two to three years poorer quality manufacturers will drop out of the market and China?s manufacturers will look to compete in international markets as well as domestic


Globally, Chatterjee foresees that while regulators are actively diverging in their philosophies, technology and innovation is simultaneously converging ? with frameworks grounded in scientific tools and analytical techniques.

Individual patients
For example, process validation in the future will be completed for individual patients, not batches. CAR-T and NGS have opened a potential regulatory pathway for even 3-D bioprinting of organs to follow.

?We have seen ground-breaking drug therapies and diagnostics approved in the last five years that position regulatory bodies to embrace these new innovations. Whether risk is managed via enhanced control and oversight, such as with the Europe’s GDPR legislation, or is a by-product of intelligently gathered real-world data, as provided under the United States? 21st Century Cures Act, the regulatory evaluation in each framework required to evaluate these new technologies will be grounded in today?s scientific tools and analytic techniques,” Chatterjee said.

“Technology is playing an increasingly large role in improving rates of attrition. Over the next five years, big data will catalyse drug discovery with R&D leading to quicker advancement of more targeted therapies” he added.

The full findings of the CPhI Annual Report will include 12 in-depth expert contributions as well as the CPhI Manufacturing and Bio leagues tables, which will evaluate the relative reputations of each major pharma country.

“CPhI Worldwide, where 45,000 executives combine their knowledge, is widely seen as a bellwether of industry trends and analysis,” CPhI’s Brand Director Europe, Orhan Caglayan said.

“Our Annual Report experts show China is now making great strides in harmonising with international standards, so it will be interesting to see over the next few years if its reputation in our annual report league tables continues to improve. However, the effects of patent extensions whilst clearly beneficial for big pharma may mean there are a number of late entering generics companies. But what is most exciting is the impact big data could have on bringing process improvements to market as well as in drug discovery. In fact, this year we are specifically holding sessions exploring the impact big data, machine learning and digital will have on pharma over the years ahead. The vastly expanded content agenda will address many of the opportunities and threats across both bio and small molecule industries,? Caglayan concluded.


Last Editorial Review: September 18, 2018

Featured Image: Cost of healthCare: ? 2010 ? 2018 Fotolia. Used with permission.

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