Latin America Roundup: Mexico’s patent office, COFEPRIS sign agreement on drug patents

Officials with Mexico’s patent office and its pharmaceutical regulator have signed a new agreement aimed at preemptively clarifying patent protections for drugs in hopes of speeding the review process.

The Federal Commission for Protection Against Health Risks (COFEPRIS) announced the agreement on 19 February, calling it a key step in improving transparency and coordination between the institutions and a move that would help drug and device makers as well as assure steadier supplies of generics in local markets.

Under Mexico’s current system, in place since 2003, pharmaceutical patents are not linked to specific products but to active ingredients. It can be difficult for companies to identify which patents may apply to a particular product under review, leading companies to contract law firms for extensive outside analyses that can drag out the approval process.

The new rule was developed under a framework established by the United States-Mexico-Canada Agreement, a free-trade pact in force since 2020. It establishes more detailed reporting requirements from COFEPRIS and from Mexico’s patent and trademark office (IMPI) that may reduce the need for outside research and analysis.

For every product under review, COFEPRIS will provide the patent office with information on its pharmacology, therapeutic indications, and mode of use, and whether any party has contested its registration. IMPI will publish more detailed information on product IP and will supply COFEPRIS with extensive information on its IP protections for each product under review, including on related patents, patent holders and licensees, and the type or category of patent protection.

Attorneys with Basham, a Mexico-City law firm, lauded the agreement as representing progress in IP protection for the pharmaceutical sector, since “it more clearly establishes the information that will be exchanged between IMPI and COFEPRIS.”

Statement (Spanish)

Lilly says it will invest more if Mexico speeds regulation

Representatives of the Eli Lilly, which invested more than $100 million in Mexico last year and has 67 ongoing clinical studies there, told members of a health business forum that it would increase its investments further if Mexico achieved more regulatory agility.

According to a 13 February report in the business newspaper El Economista, Rubén Ortiz Vásquez, Lilly’s director for Latin America and the Caribbean, told attendees of the forum that the company was “optimistic” about increasing its investments but that this “depends on many factors, one of which is regulatory speed.” Ortiz complained that Lilly has had processes delayed by four months or had fallen apart entirely.

At the same event, Mexico health minister David Kershenobich responded to Ortiz’s comments by saying that regulators were committed to improving conditions for the pharmaceutical industry, a sentiment frequently echoed by COFEPRIS head Armida Zúñiga Estrada in recent weeks.

Kershenobich added that Mexican health officials had been pressing Lilly to conduct clinical trials in Mexico that “go beyond just approving an innovative medication but also help meet our public health needs.”

El Economista (Spanish)

Chile adopts reliance process for biologics, new blood banking rules

Chile’s Public Health institute (ISP) has established reliance-based processes for biological products.

According to the new rule, signed 22 February, a biologic is eligible if it has been approved by at least two other regulatory authorities, including the European Medicines Agency as well as the national regulatory authorities in the US, Australia, UK, and Japan. If a product has been rejected by any one of these five agencies, it cannot receive reliance-based approval in Chile.

Importantly, products that have received only conditional or emergency-use approvals will not be considered candidates for reliance-based approval in Chile.

On 25 February, the ISP published new rules on blood banking, focusing on the safe use, handling, and storage of immunohematology reagents used in transfusion medicine.

The rules were created in accordance with broader Pan-American Health Organization regulatory guidance from 2022 and a subsequent public comment period. The rules, according to a statement by ISP, “Will help guarantee the quality and safety of the health services in which [reagents] are used,” while entities selling the products will have “an authorized place to store them,” ISP said. The agency says it will hold stakeholder meetings on the rules in March.

Argentina, PAHO officials meet despite planned WHO withdrawal

Although Argentina president Javier Milei’s stated on 5 February that he would end his country’s membership in the World Health Organization over ostensible “crimes against humanity,” Argentina health minister Mario Lugones met days later with officials from the Pan-American Health Organization, the Americas arm of WHO.

Argentina and the PAHO officials agreed to move forward with the acquisition of laboratory supplies and medicines through PAHO’s Revolving Fund program, the health ministry said in a statement 11 February, adding that the meeting “reaffirmed the health ministry’s commitment to guaranteeing access to essential supplies and health technologies without interruption.”

The country “will continue to count on the technical help and financial instruments of PAHO,” according to the statement, in which the proposed WHO withdrawal was not mentioned.

Statement (Spanish)

Ecuador gives device companies until May to get into compliance

In Ecuador, where fewer than 1% of medical devices used are made nationally, regulators have announced that companies have through May to prove compliance with manufacturing standards – or face withdrawals from the market.

The comprehensive standards, which follow international device guidelines and cover everything from fabrication to labeling to registration processes, were adopted in November 2023 in part to help more Ecuadoran companies get into the device market. Manufacturer compliance must be certified by the country’s National Agency of Regulation, Control, and Health Surveillance (ARSCA).

In a statement issued 5 February, ARSCA said that non-certified companies would face licensing suspensions and/or withdrawal of their products starting May 10.

Statement (Spanish)

Latin America Roundup: Mexico’s patent office, COFEPRIS sign agreement on drug patents

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