INFO KGV | LIFE SCIENCES APRIL 2021

Anvisa publishes rule on price monitoring of medical devices

By Kestener & Vieira Advogados

 

On 12 March 2021, the Brazilian Health Surveillance Agency (Anvisa), published RDC Resolution No 478/2021 (Portuguese language) which provides for the economic monitoring of certain medical devices with valid a marketing authorisation (MA) from Anvisa.

The Resolution aims to collect data and reduce information asymmetry about these products, which are selected according to the following criteria:

• Economic impact on the public health system.
• Economic impact on the health insurance market
• Relevance to public health.

Normative Instruction No 85/2021 (Portuguese language) provides a list of the selected medical devices and groups them by technical similarity. This list may be updated by Anvisa, at its discretion, or by request from interested parties, based on a technical explanation regarding the medical devices’ attributes that would justify their inclusion in or exclusion from the list.

Anvisa may request information from MA holders about their products. Answering the request is mandatory and failure to comply may result in the penalties provided by Law No 6,437/1977 (Portuguese language).

Finally, Anvisa will publish the results of the price monitoring survey on a specific website, listing the price advertised among each of the technically similar device groups. This list will not contain sensitive commercial information about the products, nor will it list their individual prices.

The above-mentioned procedures will be presented by Anvisa at the “2021 Fair Pricing Forum” event, organised by World Health Organization, which will discuss measures to promote transparency and accessibility to drugs, vaccines and medical devices.

 

Anvisa sets forth resolution regarding importation of products by health units

By Kestener & Vieira Advogados

 

 On 8 April 2021, the Brazilian Health Surveillance Agency (Anvisa) published RDC Resolution No 488/2021 (Portuguese language) which stipulates mandatory documentation and procedures for the importation by health units, for their own use, of products that are subject to health surveillance. The Resolution entered into force on the same date.

According to the Resolution, “health units” are “foundations, civil society organisations of public interest, health insurance companies, state and municipal Secretariats and military organisations” and “own use” supposes that the importation does not entail commercial activities regarding the products, such as “distribution, donation, reselling, or commercialisation”.

The Resolution sets forth different procedures for the importation of products with and without a marketing authorisation (MA) from Anvisa. For products without an MA, the procedure is more precise than previous one set forth by the revoked RDC Resolution No 383/2020 (Portuguese language), which only determined that any decision on the matter would be subject to Anvisa’s Collegiate Board of Directors (Dicol).

While the decision still resides within Dicol’s scope, the health unit must present specific documents and information about the products, such as: (i) proof that the product has an MA within the country of shipment and (ii) technical justification about the medical need and the impossibility of fulfilment by the national industry.

The resolution determines that the applicable rules of RDC Resolution No 81/2008 (Portuguese language) remain mandatory and will be assessed in the importation process by the technical department of ports, airports and borders.

 

Anvisa attends ICMRA meeting about COVID-19 products

By Kestener & Vieira Advogados

 

 The Brazilian Health Surveillance Agency (Anvisa) announced that on 24 March 2021 it attended a meeting of the Executive Committee of the International Coalition of Medicines Regulatory Authorities (ICMRA), which is composed of national and transnational health authorities that seek to “provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues”.

The meeting mainly discussed measures against the COVID-19 pandemic, focusing on exchange of information about the evaluation of drugs and vaccines within each member’s jurisdiction, initiatives for monitoring the vaccines in use, as well as measures to enhance regulatory flexibility and agility.

The members highlighted the importance of the transparency and integrity of clinical data for the effective evaluation of quality, safety and efficacy of the vaccines (as well as for therapeutics) that are being developed within the context of the pandemic. Furthermore, they noted that there are common documentation gaps coming from some manufacturers and agreed on the importance of sharing information between regulatory authorities to enhance analysis of the products.

 

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”