Over 2023 and the beginning of 2024, the life sciences sector has been heated by debates and changes, which varied from amendments to rules from the Brazilian Food & Drug Agency (ANVISA) to proposals to amend the Brazilian Patent Statute (BPS).
Below, we present some of the discussions and landmarks that we considered to have an important impact on the practices of companies and lawyers acting in this field.
In December 2023, ANVISA amended its own regulations (Ordinance # 47/2009) on drug labels and leaflets to authorize skinny labeling.
Generics and branded generics (also called “similar” drugs) are now allowed not to adopt the same leaflet from the reference drug and, therefore, not to list all their therapeutical indications, removing those that are protected by patents or included in the scope of patent applications.
The measure allegedly seeks to expand access to drugs. However, the manner it was made –via an amendment to an ordinance issued by ANVISA – met criticism, as there would be a legal obstacle to do so. This is because Law #6,360/76 – which regulates surveillance of drugs by ANVISA itself – does not allow skinny label or carve out and requires that a generic or similar drug has the same therapeutic indications as the reference drug. Besides this, some warned to the risk of encouraging off-label prescriptions and considered that the amendment could difficult the use of leaflets as an evidence of pharmaceutical patents infringement and impact the enforcement of “use” patents in Brazil.
The off-label prescription of drugs – which occurs whenever a drug is used in a manner that is not in accordance with the label approved by ANVISA – is a topic that is frequently in the spotlight.
Since 2022, Law # 8,080/1990, which organizes the public healthcare services in Brazil, authorizes the Unified Health System (SUS) to pay for drugs which use indication is different from those of the label approved by ANVISA, as long as such use is recommended by the National Commission for the Incorporation of Technologies into the SUS (CONITEC) with basis on scientific evidence on efficacy, accuracy, effectiveness and safety, and it is standardized in a protocol established by the Ministry of Health (MoH). In other words, under the above conditions, doctors from SUS were expressly authorized to prescribe unapproved uses of an approved drug.
Also in 2022, the Congress amended Law # 9,656/98, which regulates private health insurance plans, to establish the obligation to cover treatments that are not included in the refence list from the National Agency for Supplementary Health Services (ANS), provided that: (i) a doctor prescribes the treatment; and (ii) there is demonstration of its effectiveness, based on scientific evidence and a therapeutic plan; or there are recommendations by CONITEC or a worldwide renowned entity from a country where the treatment is approved as well.
After this, the caselaw from the Superior Court of Justice changed to acknowledge that ANS’ list is merely a basic reference for health insurance service providers. And, in September 2023, the 4th Panel decided that they must afford treatments with off-label use of drugs prescribed by doctors, as long as the drug has marketing approval from ANVISA.
Recently, in April 2024, Bill of Law # 1,393 proposed a new amendment to Law # 9,656/98 to expressly establish that health insurance plans must cover off-label use of drugs, whenever they are registered at ANVISA and prescribed by a doctor. This proposal is pending at the House of Representatives.
Seeking to reduce the time of analysis of patent applications, the Bill of Law # 2,210 proposes to amend the BPS to eliminate the automatic 36-month term for applicants to request the examination of the patent application and restrict the capability of amending the application only until the beginning of technical examination1. Hence, right after the filing, the Brazilian Patent and Trademark Office (BRPTO) would – at least in theory – be allowed to immediately put the application in the queue for examination.
Criticism has arisen as this proposal limits the possibility of amending the patent application and favors the conclusion of the analysis of applications in Brazil before than in other jurisdictions. A quick conclusion of examination paired with the limitations already imposed by the BRPTO when it comes to filing of divisionals and amendments to the set of claims may hinder applicants from having a level of protection and quality in the patent scope on level with patents filed abroad.
Another relevant topic concerns to the partnerships to transfer knowledge of drug technologies to the Federal Government, which are commonly known by the acronym PDP.
PDPs are undoubtedly in the Government’s agenda. In 2023, Decrees #11,714 and #11,715, respectively, established new rules about the committee and commission responsible for supervising PDPs and put in place the National Strategy for the Development of the Health Economic-Industrial Complex.
Also, due to recommendations from the Federal Court of Auditors (TCU), the MoH started to revise the rules applicable to PDPs. Among others, the main fragilities which need to be resolved are the lack of objective criteria for analyzing PDP proposals and to define which drugs are eligible for PDPs, and the legal uncertainty regarding the selection of the partner.
Between December 2023 and February 2024, a public hearing was held to collect contributions to the draft of the new ordinance that will govern PDPs, giving us a preview of what is to come. Among the main developments are the improvements of the proceeding to select private partners, the phases and milestones to initiate and conclude the technology transfer, and the monitoring measures.
So far, the MoH has not finalized the revision of the rules on PDPs, but it is fair to expect that this will happen anytime soon. Especially considering that the MoH was planning to launch another round of PDPs in the upcoming future, but in September 2023 the TCU determined that new PDPs cannot be entered into until the new rules are issued.
It has been a busy time for those acting in the life sciences sector in Brazil. Recently, there have been important changes to several rules that are applicable to the area and many more are about to come.
Not all changes are immune to criticism and, as seen, some of them raise important concerns indeed. However, worthy of note is the revision of rules applicable to PDPs, as the recent debates in the TCU have proven to be very fruitful for the improvement of the rules applicable to this kind of partnerships, in order to ensure more transparency and legal certainty. This had been expected for a long time by those working in the area.
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