The report traces how regulatory policy, in particular relating to intellectual property, has shaped the emerging markets. In doing so, it explores differences in the treatment of generics and innovative medicines, from a policy/regulatory perspective. It also looks to the future to see in which direction government policy is headed.
Features and benefits * Understand the operating environment in the emerging markets from an intellectual property and wider regulatory perspective.
* Enables research-based companies to prepare for the impact of generic competition in emerging markets.
* Evaluate which countries enforce intellectual property rights most effectively.
* Identify in which countries your products will be most at risk of compulsory licensing.
* Assess whether governments’ policies favor generics over innovative products.
Highlights
Although all of the emerging markets (except Russia) covered by the report have updated their national legislation to comply with TRIPS, they have been resisting pressure to implement many of the "TRIPS-plus" measures that have been called for by the research-based industry and by developed countries such as the US.
A recurrent trend in many of the emerging markets is that the drug approval process for generics is becoming more rigorous, with a view to ensuring that the safety and efficacy of these products meets the same standards as patent-protected medicines.
There are two main driving forces which will in future encourage emerging markets to implement more stringent measures for protecting intellectual property: the lure of potentially lucrative free trade agreements; and the fact that, in several cases - their domestic pharmaceutical industry is moving towards an innovation-led approach.
Your key questions answered
* What is the current state of IP protection in the emerging markets of Brazil, China, India, Mexico, Russia, and Turkey?
* Do these emerging markets conform to international norms in terms of IP protection?
* In what ways do regulations differ for innovative products and generics?
* Do governments’ policies favor generics over innovative products and in what direction are future governments’ policies headed?
* Is there a realistic threat of compulsory licensing?
Executive Summary
Brazil
China
India
Mexico
Russia
Turkey
About the author
Disclaimer
Summary
Markets in context
International IP framework
TRIPS
ACTA
IMPACT
Industry viewpoint
IP trends in emerging markets
Pipeline protection
Incremental innovations
Data protection
Compulsory licensing
Other regulatory trends
Future prospects
Brazil
Summary
Evolution of IP protection
Patent application process
Drug approval process
Compulsory licensing
Kaletra
Stocrin
Viread
Pricing & reimbursement
Patent extensions/litigation
Viagra
Lipitor
Group trials proposal
Generics market progress
Industry perspective
Relationship with Europe
Future prospects
Technology transfers to strengthen local industry
Originator companies to adopt new strategies
China
Summary
Evolution of IP protection
Drug approval process
Practical effects of new regulations
Pricing & reimbursement
Price controls
Prescribing practices
Compulsory licensing
Patent extensions/litigation
Viagra
Docetaxel
Generics market progress
Industry perspective
Future prospects
Government strives to encourage innovation
Wider picture
India
Summary
Evolution of IP protection
Membership of WTO leads to stricter patent regulations
Drug approval process
Compulsory licensing
Pricing & reimbursement
Price controls
Patent extensions/litigation
Glivec (imatinib)
Valcyte (valganciclovir)
Nexavar (sorafenib)
Generics market progress
Industry perspective
Research-based industry viewpoint
Generics industry viewpoint
International relations
Future prospects
Other policies
Mexico
Summary
Evolution of IP protection
Pipeline patent extensions
Data exclusivity
Drug approval process
Rise of bioequivalent generics
Removal of local manufacturing requirement
Compulsory licensing
Pricing & reimbursement
Public sector
Private sector
Patent extensions/litigation
Generics market progress
Industry perspective
Future prospects
Russia
Summary
Evolution of IP protection
Drug approval process
Pricing & reimbursement
Price controls
Compulsory licensing
Patent extensions/litigation
Generics market progress
Industry perspective
Future prospects
Pharma 2020
Health 2020
Turkey
Summary
Evolution of IP protection
Drug approval process
Data exclusivity
Approval delays
Pricing & reimbursement
Prescribing practices
Compulsory licensing
Patent extensions/litigation
Generics market progress
Industry perspective
Future prospects
Appendix
Scope
Methodology
Abbreviations
References
Endnotes
Other selected research from the 'Regulation & Policy' category:
Reissuing pharmaceuticals in the NHS: Challenging the chain of trust
Biosimilars: Regulatory Issues - Europe continues to make strides while the US lags behind
Other selected research from the 'Intellectual Property' category:
Intellectual Property Protection and Regulatory Regimes in Emerging Markets
Patent Protection Strategies: Maximizing market exclusivity