CPhI Annual Report 2018 Part 2: the impact of global regulation and convergence. China is harmonizing to ICH standards at feverish pace and will force poor quality manufacturers out of market
Amsterdam, 18th September 2018: CPhI Worldwide the world’s largest pharma event – taking place in Madrid (9-11, October 2018) and organized by UBM (part of Informa plc) – has released the second part of its annual report, which evaluates the effects of regulatory divergence, trade agreements and IP rights over the next 5-years. Two annual report experts, 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.
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 [generic company] to gain consent from patent holder prior to use of data in (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 healthcare costs could potentially rise globally by as much as $100bn. The implications for the patented pharma industry is that it is likely to come under sustained pressure in the medium term (5-10 years hence) to reduce prices.
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.
Globally, he foresees that whilst regulators are actively diverging in their philosophies, technology and innovation is simultaneously converging – with frameworks grounded in scientific tools and analytical techniques. 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 EUs GDPR legislation, or is a by-product of intelligently gathered real-world data, as provided under the US’s 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. 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” added Chatterjee.
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 Brand Director Europe, Orhan Caglayan added: “CPhI Worldwide, where 45,000 executives combine their knowledge, is widely seen as a bellwether of industry trends and analysis. 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.”
CPhI Annual Report expert summaries:
Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates
- Innovation convergence and science-based approaches will allow for divergent yet integrated regulatory pathways
- 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
- Over the next five years, big data will catalyse drug discovery with R&D leading to quicker advancement of more targeted therapies
- The future will be constructed on science-based regulatory frameworks – for example, with process validation done for individual patients, not batches. CAR-T and NGS have opened a regulatory pathway for even 3-D bioprinting of organs to follow
Dilip Shah, CEO of Vision Consulting Group
5-10 year trends
- Global trend towards patent term restoration/extension, e.g. Regional Comprehensive Economic Partnership (RCEP) text seeks to redefine protection period to 20 years from the date of marketing approval.
- ‘Patent linkage’ under Comprehensive and Progressive Trans-Pacific Partnership Agreement (CPTPP) will require [generic company] to gain consent from patent holder prior to use of data in (generic) marketing approval.
- CETA between and the EU and Canada has similar patent restoration as does EU-Japan economic partnership agreement.
- The net result of these patent regulations is that patients may need to wait 5-10 years longer for access to generic medicine.
- This will significantly increase the overall cost of healthcare in developed and developing countries by as much as $ 100 Bn over the next five 5 years.
- Unintended consequences: In the medium-term the pharma industry will likely face a sizeable backlash from the government, health activists, and wider society that may see a fundamental reform of how companies are reimbursed for innovative medicines globally.