Latin America Roundup: Push for Uraguay medicines agency faces opposition
Uruguay’s top health official, Cristina Lustemberg, has sought dialogue with opposition-party lawmakers in an attempt to push forward a project to create a national medicines agency, which Uruguay currently lacks.In May, Senator Pedro Bordaberry Herrán proposed an alternative process by which Uruguay would automatically ratify approvals by trusted foreign agencies. The proposed legislation would speed drugmakers’ access to the local market but would do little to control pricing, improve pharmacovigilance, bolster local manufacturing capacity or advance specific public health priorities. Bordaberry’s proposal would explicitly avoid the creation of a national medicines agency.
Lustemberg has expressed to national and international media that the proposed creation of a national medicines regulator would “improve the traceability of medications" and ensure that “the most up-to-date medicines are available at affordable prices.” She described the project as “something that should have been done many years ago." Currently, Uraguay’s Ministry of Public Health regulates medicines in the country.
Bordaberry, in turn, has painted the effort as redundant and wasteful, saying that Uruguay lacks the resources and technical expertise to regulate medicines effectively and should instead rely on decisions by reputable outside agencies such as the US Food and Drug Administration and the European Medicines Agency.
In a 12 May press conference, Lustemberg said she has reached out to Bordaberry. She also sought to responded to the senator’s criticisms, noting that Uruguay is the only Latin American nation without a dedicated medicines agency, a situation that has resulted in the unfettered sale of “just about any pharmaceutical product” in the country. Bordaberry’s bill, she said “only underscores a growing consciousness about the need to strengthen vigilance” of Uruguay’s pharmaceutical market.
El País (Spanish)
Paraguay joins ICH as observer member
Paraguay’s National Directorate of Health Surveillance (DINAVISA) has become the latest Latin American agency to join the International Council for Harmonisation (ICH) as an observer member.
The observer designation, shared by agencies in Cuba, Peru, Colombia, and El Salvador, allows representatives to participate in ICH’s meetings and working groups but not to vote on guidelines or other measures. ICH members in the region with full voting rights comprise the national regulatory authorities of Mexico, Brazil, and Argentina.
In a statement issued on Facebook on 13 May, DINAVISA hailed its acceptance as “very significant, placing the regulatory authority at the forefront of international standards for safeguarding the health of the Paraguayan population.” Three days later, DINAVISA announced it had also joined the International Pharmaceutical Regulators Programme (IPRP), though the IPRP website has not been updated to reflect the agency’s admission.
Paraguay has been proactive about participating in international harmonization efforts. It has also sought a more systematic approach to medicines pricing. DINAVISA regulators met on 5-7 May with representatives from the Pan-American Health Organization (PAHO) to assess the country’s ongoing efforts to implement external price referencing methodology (EPR) and also to explore alternatives, according to a PAHO statement. Representatives of the Paraguayan pharmaceutical industry participated in the meetings.
Statement
Peru advances investigations into IV solutions deaths
Prosecutors and legislators in Peru are advancing separate investigations related to the recent deaths of 7 patients from intravenous saline solutions containing too-high concentrations of salt.
Investigators with Peru’s attorney general’s office recruited a technical team from the country’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) for a site visit to the embattled manufacturer, Medifarma, according to a 14 May report in the media outlet Carretas.
The team took samples from a mixing tank that a former employee, now cooperating with investigators, pointed to as a source of the problem. Allegedly neither the mixing nor the sampling of the lots was properly conducted, leading to inconsistencies in the concentration of the packaged solutions distributed to hospitals. Some 4,000 confiscated units of the solutions remain to be analyzed, the prosecutors told media.
A congressional health commission will be holding hearings and conducting its own investigations, the Peruvian media outlet Correo reported on 14 May.
Bolivian regulators suspend ranitidine products
Regulators with Bolivia’s State Agency for Medicines and Health Technology (AGEMED) have banned the sale of all products containing the medication ranitidine, citing unacceptable levels of N-nitrosodimethylamine (NDMA), an impurity present in ranitidine products that is a probable carcinogen, according to the US Centers for Disease Control and Prevention.
AGEMED’s announcement, delivered on Facebook in early May, came a full five years after the US Food and Drug Administration requested the voluntary withdrawal of ranitidine-containing products in the US, also over concerns about NDMA. The documentation cited by AGEMED dates from that period. The agency did not comment on why it had not acted earlier.
Ranitidine is a treatment for reflux, indigestion and other gastric conditions that works by suppressing the production of stomach acids.
Statement (Spanish)
ANVISA invites comment on new rules for devices
The Brazil Health Regulatory Agency on 8 May announced the opening of a “directed consultation,” or comment period, to support the creation of a new national regulatory framework for medical devices. The consultation, in which only reporting entities in the country’s national health surveillance system may participate, “will address the classification and regulation of reusable and single-use medical devices, and good practices for processing [related to] these products,” the agency said. The comment period will run through 13 June.
Statement (ANVISA)
Mexico resumes mass purchase of medicines
After revelations of price gouging, fraudulent pricing, and late delivery of products caused initial efforts to be paused, and the offending companies identified and excluded, Mexico’s mass drugs-purchasing scheme has resumed, Mexican news outlets reported.
Some 21 oncology medicines are prioritized for this purchasing round, which will be completed by the end of May, Eduardo Clark, Mexico’s undersecretary for health, told news outlets on 14 and 15 May. Products will be delivered immediately to clinics and hospitals in Mexico’s public health system, Clark said.
Video (Spanish)
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