Generic Biosimilar Medicines Association

Making Medicines Affordable

  • Home
  • About GBMA
    • Contact us
    • GBMA Members
    • Guiding principles
    • Code of Practice
      • Code Complaint Committee
      • Event Reporting
        • Educational Events
        • Non-Price Benefit Reports
      • Annual Review
        • 2011
        • 2012
        • 2013
        • 2014
        • 2015
        • 2016
        • 2017
        • 2018
        • 2019
      • Lodging a complaint
    • Media Enquiries
    • Our Objectives
    • Links
  • Advocacy
    • Extended Strategic Agreement
    • Generic Medicines Working Group (GMWG)
    • Submissions
  • Generics
    • Facts and Fallacies
    • Key Figures on Generic Medicines
    • What is a Generic Medicine?
    • Bioequivalence Explained
  • Biosimilars
    • IGBA Global Biosimilars Week
    • GBMA Position on Biosimilars
      • Impact of Biosimilars
      • Switching
      • Pharmacy Substitution
      • Regulation
      • Awareness and Uptake
      • Naming
    • Key Figures on Biosimilars
  • Topics
    • IGBA
    • Price Disclosure
    • Intellectual Property
    • International Trade Agreements
  • News
    • News 2020
    • News 2019
    • News 2018
    • News 2017
    • News 2016
    • News 2015
    • News 2014
  • GBMA Education
  • COVID-19 Virus
    • COVID-19 Virus: The Facts
You are here: Home / Generic Medicines Facts / Topics / International Trade Agreements

International Trade Agreements

GBMA supports the negotiation of international trade agreements aimed at fostering trade in generic and biosimilar medicines.

The competitiveness of the generic and biosimilar medicines industry is threatened by regulatory divergences with respect to country requirements for the approval and marketing of generic and biosimilar medicines, and excessive standards for intellectual property rights (IPR) protection. Specific instances of IPR abuse/misuse, as well as pricing and reimbursement policies are also areas of concern.

The removal of such barriers will reduce costs for the development of generic and biosimilar medicines, and ensure that such products can be traded freely and enter markets without delay.

To this end, GBMA support the IGBA set of trade principles that should systematically inform trade negotiations. These principles concern four key priority areas:

  1. Fostering regulatory convergence of the requirements for the approval of generic and biosimilar medicines, and recognition of compliance inspections through the establishment of frameworks providing for regulatory cooperation;
  2. Ensuring that the regulation of IPRs in trade agreements does not lead to excessive IP standards that delay access to generic and biosimilar products;
  3. Establishing an appropriate framework of pro-competitive provisions to prevent IPR abuse/misuse, and;
  4. Establishing an appropriate framework for incentivising generic and biosimilar medicines’ market access.

For more information please click the below link:

Fostering International Trade in Generic and Biosimilar Medicines

Our Members

Juno
Juno
Sandoz logo
Sandoz logo
Viatris
Viatris
Arrow logo
Arrow logo
apotex
apotex
Celltrion Healthcare
Celltrion Healthcare
Fresnius Kabi
Fresnius Kabi
Fresnius Kabi
generic_partners
generic_partners
southern_cross
southern_cross
commercial_eyes
commercial_eyes
sinapse
sinapse

Generic Medicines: The Facts

Generic Medicines Facts

Generic medicines are quality medicines at affordable prices. Ask your doctor to prescribe a generic medicine, or ask for a generic medicine next time you take your prescription to the pharmacy. … More…

The promise of Biosimilars

Biosimilars

https://youtu.be/sBDur7xa084   Biosimilars provide a unique opportunity to help manage the growing costs of biological medicines on the PBS. They offer therapeutically equivalent and … More…

Announcement of Independent Chair

December 9, 2020

9 December 2020 Canberra, ACT Global health policy powerhouse, Jane Halton AO PSM, joins GBMA as its inaugural Independent … More...

Confidence in biosimilar medicines, amongst specialists, GP’s and Pharmacists

December 8, 2020

12 November 2020 Canberra, ACT New research shows prescriber … More...

IGBA Launches First Global Biosimilars Week

December 7, 2020

16 November 2020 Geneva, Switzerland Today the International Generic and … More…

© 2021 Generic Medicines Industry Association Pty Ltd | Site Map | Contact Us