Asia-Pacific Roundup: MSF accuses UK of ‘seeking to gut India’s patent and drug regulatory laws’

Médecins Sans Frontières (MSF) has accused the UK of trying to remove safeguards from India’s patent and drug regulatory laws that make the Asian country “a manufacturing powerhouse.” MSF made the statement after reviewing a leaked copy of a section of a draft free trade agreement (FTA).

The leaked intellectual property chapter of the proposed FTA discusses topics including patents, stating that each country should provide pharma companies with “an adequate and effective mechanism to compensate the patent owner for the reduction in the effective patent term resulting” from the marketing authorization process.

The compensation could either take the form of “a period of additional sui generis protection conferring the rights conferred by the patent” or “an extension of the patent term.” Aspects of the FTA caught the attention of MSF.

“The UK’s demands are seeking to gut India’s patent and drug regulatory laws of the safeguards that make it a manufacturing powerhouse,” Leena Menghaney, South Asia head, MSF’s access campaign, said. “Introducing more and more IP hoops for generic manufacturers in India to jump through will have a chilling effect on the country’s ability to supply millions of people around the world with affordable, lifesaving generic medicines.”

As MFS sees things, the UK has put forward a “disastrous proposal.” MSF wants India to reject the UK proposal “and demonstrate its commitment to retaining robust and sustainable production of lifesaving generic medicines at affordable prices.” The humanitarian medical non-governmental organization has also called on the UK to withdraw the proposal “completely” because of the “disastrous consequences” the “leaked IP chapter could have on the global supply of generic medicines.”

MSF cited the upcoming expiration of the basic patent on delamanid, “one of the most expensive tuberculosis drugs,” as an example of the potential impact of the UK proposal. The basic patent is set to expire next year “but measures contained in the FTA would delay the availability of more affordable generic delamanid by several years,” according to MSF.

India and UK are negotiating the FTA, a centerpiece of the European government’s argument that Brexit will bring benefits, against the backdrop of a broader global dispute over the patent system. The World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) provisions remain a controversial topic, with the dispute over COVID-19 vaccine patents bringing renewed attention to IP.

MSF Statement, Draft Proposal

TGA seeks feedback on readiness for planned switch from dual labeled ingredient names

Australia’s Therapeutic Goods Administration (TGA) is running a consultation to learn whether the healthcare sector is ready for the dual labeling of medicine ingredient names to end. The requirement for products to display the old and new ingredient name is set to end in April 2023 but TGA is questioning whether the deadline is still appropriate.

Under the original proposal, TGA estimated it would take health professionals and consumers three years to become familiar with the new ingredient names. However, “this time frame could not have predicted the impact of a pandemic on the health systems and medicine supply chains,” TGA wrote in its consultation. TGA now sees downsides to its original proposal.

“The original plan for medicine sponsors to voluntarily change labels and PI/CMI documents to remove the old ingredient name at the end of the dual labeling period has the risk of being a drawn-out and inconsistent process. It could mean, for example, in 10 years, there may be different products with the same active ingredient still expressing the active ingredient differently,” the agency wrote.

In light of its current thinking, TGA is seeking feedback on whether all dual labeled ingredient names can transition to sole names and, if so, how the transition should occur. The agency wants to make sure that the use of sole medicine ingredient names will “not cause any confusion or potential medication errors” and establish if a transition period “would help in ensuring consistent and timely changes occur across all products containing specific ingredients, and would give more clarity for health professionals and consumers than the original plan.”

TGA is accepting feedback until 19 December.

TGA Notice, More

Long-term safety worries spark TGA post-market review of spinal cord stimulation devices

TGA has begun a post-market review of the safety and performance of spinal cord stimulation (SCS) devices. Companies including Abbott, Boston Scientific and Medtronic sell SCS devices in Australia to manage conditions such as chronic intractable pain.

TGA is looking into the evidence on implantable stimulation leads and impulse generators, for both the spinal cord and peripheral spinal nerve, in response to signals it has received about the devices. While TGA is yet to post a detailed look at the data, it selects devices for post-market review based on “signals, complaints, adverse events” that it receives or “other sources of information such as overseas regulatory action or publications regarding the safety and/or performance of this type of device.”

The SCS review will reassess the safety and performance of the devices, using the real-world evidence that is now available on the use of the products in their approved indications to inform the process. The review will ensure the devices meet the essential principles and remain safe for use.

TGA has asked Australian sponsors of SCS devices to provide information including “all domestic and international incidents, adverse events and complaints” and details of any investigations and corrective actions that they have undertaken. The agency will share the outcomes of its review as they become available.

TGA Notice

Indian Pharmacopoeia Commission clarifies the implementation of new general chapters

The Indian Pharmacopoeia Commission (IPC) has clarified the requirements imposed by three new general chapters in response to questions from stakeholders about implementation and compliance.

In the ninth edition of the Indian Pharmacopoeia, which was released in July, the IPC introduced chapters on the uniformity of dosage units, elemental impurities and nitrosamine impurities. The statement published last week explains the impact of the three new general chapters on drug manufacturers.

IPC has introduced the uniformity of dosage units chapter for “information and awareness.” The chapter is not referenced in individual monographs and its adoption therefore remains optional. Adoption of the chapter on elemental impurities remains optional, too, although IPC notes that it will gradually replace the test on heavy metals in individual monographs to make it mandatory in the 2026 edition.

The third chapter, on nitrosamine impurities, is referred to in the monographs for sartan active pharmaceutical ingredients. IPC expects manufacturers of other drugs to adopt the general chapter to test for nitrosamine impurities whenever “appropriate and necessary.”

IPC Statement

Other News:

TGA has shared information to help the industry prepare for the January adoption of the standard for serialization and data matrix codes. The standard, TGO 106, sets out the requirements manufacturers need to comply with if they provide products that are serialized or include a data matrix code that encodes a Global Trade Item Number. TGA published guidance on the topic last year. TGA Notice

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has reclassified choline salicylate to ensure parents buying Bonjela for oral pain relief in children under 18 months receive advice on safe usage. Medsafe is restricting sales of the over-the-counter medicine to pharmacies. Medsafe Notice

Asia-Pacific Roundup: MSF accuses UK of ‘seeking to gut India’s patent and drug regulatory laws’

Related topics

Recommended content

Welcome to the new RAPS Digital Experience