IGBA's Trade Principles Address Regulatory Convergence and Intellectual Property Concerns

The International Generic and Biosimilars Medicines Association (IGBA), which represents generic and biosimilar medicines associations worldwide, recently released its report on how trade agreements can foster generic and biosimilar medicines and improve patient access to care.

“While trade agreements should be focused on facilitating trade between countries, all too often we see agreements that erect new barriers to the trade for generic and biosimilar medicines manufacturers and hinder access to affordable medicines” said Jim Keon, chair of IGBA and its international trade and intellectual property committee, in a statement. “The removal of such barriers would reduce costs for the development of generic and biosimilar medicines and ensure that such products can be traded freely and enter markets without delay,” he added.

In the report, IGBA says that it “strongly supports the rules-based multilateral trading system, which ensures that international trade is conducted on the basis of the rule of law and due process,” sets out its priorities for generics and biosimilars in trade agreements.

First, IGBA calls for greater transparency in legislative and regulatory processes for product, as well as greater regulatory convergence of requirements related to product approval. The organization voices its support for conditions that will allow generics—particularly complex generics—to be developed in single programs, and it supports convergence among requirements for assessment for generics to reduce development costs. Guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use can serve as a basis for domestic legislation.

With respect to biosimilars, IGBA notes that some regulators are moving toward allowing the use of foreign comparator products, “which should also increasingly waive the requirement for bridging data in certain instances.” The organization said that trade agreements could require frameworks that allow global development programs for biosimilars and convergence of data requirements for approval.

IGBA also calls for trade agreements to build on and further develop collaborative approaches to good manufacturing practice, and to avoid duplication of inspections.

The organization raises concerns about intellectual property provisions in trade agreements; bilateral rather than multilateral negotiations can lead to the creation of new standards for intellectual property that could alter the balance between encouraging investment and ensuring competition. Therefore, provisions on patentability of inventions, says IGBA, should reflect the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement).

Patent linkage mechanisms—under which approval for a generic cannot be granted until patents on the originator are expired or declared invalid—should be avoided in trade agreements. On the other hand, regulatory review clauses, which allow generic and biosimilar makers to use patented inventions for the purposes of developing information that will help them later gain regulatory approval, should be mandatory.

Data exclusivity, says IGBA, is not mandated by the TRIPs Agreement, and interpretations of the agreement used to introduce data exclusivity requirements into trade agreements should be rejected; agreements should not contain provisions related to data exclusivity that extend beyond TIRPs requirements. Additionally, IGBA opposes inclusion of requirements leading to longer market exclusivity period for biologics.

In cases in which some countries can grant extended patent terms, such as through a supplementary protection certificate, generic and biosimilar developers should be allowed to export their products during the term of extended protection. Patents should not be subject to measures such as criminal enforcement.

Finally, IGBA also has concerns about abusive intellectual property-related practices, and it says that it will gladly engage with negotiators to provide detailed information on how treaty language can safeguard against abuses.

Lastly, incentives for biosimilars and generics are also of concern for the organization, and the report states that countries where patent linkage exists and where data protection is high particularly need clear frameworks for incentives.