IGBA Addresses Intellectual Property and Regulatory Convergence Concerns

Intellectual PropertyAbbreviated as IGBA, the International Generic and Biosimilar Medicines Association, has recently released a report on the way trade agreements can nurture the generic and biosimilar medicines and enhance patient access to care.

In the report, the association said that it firmly supports the rules-based multilateral trading system and sets out its priorities for the generic and biosimilar products in trade agreements. It explained that the multilateral trading system ensures that international trade is carried out by considering the rule of law and due process.

Jim Keon, the chair of IGBA International Trade and Intellectual Property Committee, in a statement said that while trade agreements should emphasize facilitating trade amongst countries, all too often they see agreements that erect novel barriers to trade for generic and biosimilar medications manufacturers and impede access to inexpensive medicines.

He further added that the removal of these barriers would provide many benefits like it will reduce the costs for developing generic and biosimilar medicines and shall allow free trading along with on-time entry of products into the market.

Firstly, IGBA called for considerable transparency in legislative and administrative processes for products, along with remarkable regulatory convergence of needs that pertains to product approval. It raised its voice for conditions that will enable the development of generics in single programs and supports convergence in requirements for generics assessment to reduce development costs.

In regards to biosimilars, IGBA noted some regulators who are looking for letting the use of foreign comparator products. And it said that the trade agreements could need frameworks that approve global development programs and convergence of data requirements for biosimilars.

The organization also called for trade agreements to create and develop collaborative approaches for product manufacturing practice, and evade duplication of inspections.

The association raised concerns regarding Intellectual Property (IP) provisions in trade agreements and commented that rather than multilateral, bilateral negotiations could lead to the formation of novel IP standards that can alter the balance between ensuring competition and encouraging investment. Therefore, the procurements on the patentability of inventions should rely on the TRIPS agreement, the Agreement on Trade-Related Aspects of Intellectual Property Rights.

IGBA continued that data exclusivity is not mandated by the TRIPS Agreement and ideas to introduce this exclusivity into trade agreements should be rejected. It even opposed the inclusion of requirements generating longer market exclusivity time for biologics.

The association also revealed its concerns related to abusive intellectual property-related practices and announced that it would engage with negotiators for providing detailed information on the way treaty language can protect against abuses.

Lastly, the report showed IGBA’s concern about the incentives for generics and biosimilars and stated that the countrieswhere patent linkage exists and data protection is highshould ensure having clear frameworks emphasizing incentives. For more visit: https://www.trademarkmaldives.com

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