Risk-sharing agreements in the incorporation of innovative technologies by the SUS

Guillermo Glassman

SPLAW Advogados, São Paulo

guillermo.glassman@splaw.com.br

Benny Spiewak

SPLAW Advogados, São Paulo

benny.spiewak@splaw.com.br

Incorporating new pharmaceutical technologies is one of the main challenges facing Brazil’s Unified Health System (SUS). Inspired by the United Kingdom model, Brazil’s National Commission for the Incorporation of Technology in the SUS (CONITEC) has based the analysis of incorporation on a combination of cost and effectiveness. However, in many cases, uncertainty remains about the advantage of replacing technologies due to the need for more sufficient data, which delays public access to these treatments through the regular channels. This, in turn, encourages judicialization of the matter by patients demanding access to the most up-to-date medicines.

As a means of accelerating access to new treatments, Bill No 677/2021 (PL 677) of the Chamber of Deputies seeks to bring risk sharing agreements to Brazil, institutionalising a pilot project of the Ministry of Health (MS) which had been initiated in 2019, even without specific legal provisions. If adequately framed within law, the model, if structured correctly, would result in significant essential advances. Nevertheless, Bill 677 has been proceeding slowly, and the Health Commission ended its analysis failing to give the necessary adjustments required for legal certainty. That is what we will discuss below.

The right to healthcare in Brazil is guaranteed by Article 196 of the Constitution as a duty of the state. It is comprehensive (at least in the legal sphere, of should-be) and can be analysed from two perspectives. It is a universal, egalitarian, and accessible right. The SUS is its practical implementation of healthcare for everyone in Brazil. Full service is guaranteed (Art 198, II) by dispensing medicines and products of interest to health and offering therapeutic procedures (Law No 8080/90, Art 6, I,‘d’, Art 7, II and Art 19-M, I and II).

The SUS’s central political and economic tensions are focussed on the implementation of healthcare for everyone. On the one hand, the understanding that comprehensiveness encompasses actions for prevention, promotion, and recovery of health in primary, secondary, and tertiary healthcare, pharmaceutical assistance, and recovery and rehabilitation services is undisputed. On the other, strictly which medicines and treatments should be regularly provided to the population is a contentious issue, which can be witnessed, for example, by the intense judicialisation of public health.[1]

There are three main political aspects to consider in incorporating technologies and treatments within the scope of the SUS.

The state considers budgetary constraints and the scale of the system. Whereas citizens, who are represented by actively engaged patient associations, crave access to the most up-to-date technologies and treatments to restore their health and wellbeing. In addition, the health sector (suppliers of pharmaceuticals, medical devices, and equipment) expects full access to the public market for its entire portfolio, given the relevance of government demand.

The first measure to mediate tensions in the incorporation of technologies and treatments within the scope of the SUS was the creation of the Commission for the Incorporation of Technologies (CITEC) in the MS in 2006, which, two years later, became part of the structure of the Secretariat of Science, Technology and Strategic Inputs (SCTIE).[2] This agency had as its primary duty (Ordinance No 2587/08, Art 5) the incorporation or removal of health products from the list of SUS procedures and the list of the National Supplementary Health Agency (ANS).

This decision was made after reviewing clinical guidelines and therapeutic and healthcare protocols (later called Clinical Protocols and Therapeutic Guidelines – PCDT, under Art 19-N, II of Law No 8080/90). Within the scope of the SUS, such documents established criteria for the diagnosis and treatment of drugs, specifying the products to be prescribed and dispensed to patients in each case. In 2011, Law No 12401 (which included Arts 19-M to 19-U in Law No 8080/90) created the CONITEC which was inspired by the UK’s National Institute for Health and Clinical Excellence or NICE. CONITEC became responsible for advising the Ministry of Health in the matters relating to the incorporation of technologies by the SUS. This was consolidated, in the case of pharmaceuticals, in the National List of Essential Medicines – RENAME, under Decree No 7508/11 and Ordinance No 533/12, and in the amendment of the PCDT.

More recently 2019, through Ordinance No 1297, the MS experimentally adopted a modern technology incorporation model, the Risk Sharing Agreement (RSA). As in other occasions (such as in the case of the Partnerships for the Productive Development of Medicines – PDP),[3] the MS innovatively established unprecedented modelling in Brazil (called ‘pilot’ by the Ordinance) from legal instruments already known. In this case, there was uncertainty regarding the cost/effectiveness, estimated consumption, and budgetary impact of the adoption of the drug Spinraza (nusinersen) for the treatment of spinal muscular atrophy (SMA 5q) Types II and III within the scope of the SUS (such medication was dispensed by the public system only to Type I patients). The goal of the RSA was to evaluate in natural conditions the effects of the incorporation of the drug, having as a contribution of the manufacturer the reduction of its price and the assumption of unforeseen additional costs if the number of patients served exceeded the maximum expected based on the available epidemiological data.

Regardless of the specific outcome of the case, it is necessary to evaluate the suitability of the RSA model in managing the incorporation of technologies into the SUS – and not only for very high-cost drugs. The emergence of more advanced treatments in the pharmaceutical industry is common, especially in the case of incremental innovation; the advantage of such advanced treatments under the cost/effectiveness criterion remains doubtful.

As there is no regular involvement in the system by the public network, patients resort to judicialisation, compromising the public budget more intensely, given the loss of scale in the acquisition. In this context, Bill No 677/2021 (with the exact text as Ordinance No 1297) stands out, intending to increase the legal status of the RSA model.

Providing the RSAs in law, not just in a regulatory rule, is fundamental to giving them legal certainty. Indeed, the RSAs are except from the general duty to bid for the acquisition of medicines, and the targeting of part of the public demand for this procurement modality restricts the access of other interested parties in the supply of treatment alternatives. As in the case of PDPs, the broader adoption of RSAs without specific legal basis may lead to bewilderment in the administrative law community (especially in the accounting courts). The existence of specific legal rules with the definition of clear guidelines for using RSAs could solve this problem.

The establishment of a new model for the incorporation of technology into the SUS, accelerating the public’s access to new treatments, requiring contributions from the industry, and avoiding the costs of health judicialisation, is in line with the spirit of Law No 14133/21 (New Law on Biding Processes and Contracts – NLLC). However, Bill 677 warrants improvements. Therefore, that the processing of Bill 677 by the Health Committee of the Chamber of Deputies ended on 4 July 2023 without the submission of amendments is surprising. This contradicts the relevance of the issue.

In this regard, the law regulating RSAs in Brazil should seek to define more precise procurement parameters to reduce the legal uncertainty for public managers and companies without consolidated precedents on new public procurement models. The following are aspects requiring specific legal treatment:

• the form of a selection of the private partner (eg, public call or bidding process) and possible division of the public market (with more than one interested party);
• the maximum term of the partnership;
• the minimum discount applicable during the RSA and the reference price for discount (eg, average prices charged in the market, the latest acquisition of the MS or PMVG);
• the definition of RSA phases;
• methods of evaluating the advantage of the incorporation, in the light of the performance of the RSA;
• deadlines for making the treatment available after the execution of the RSA, supply schedule and the possibility of applying penalties in the event of non-compliance;
• the possibility of centralisation of SUS demand (as occurs in the case of PDPs) to obtain more significant discounts;
• rules for defining the percentage of SUS demand allocated to the RSA; and
• the possibility of demanding technological contributions (the transfer of technology to public laboratories).

After the excellent visibility that the procurement model via RSA gained in 2019, 2020, and 2021 with the creation of the MS pilot project, discussions on the topic have diminished. Nevertheless, the problems which the RSA intends to solve (or contribute to the solution) remain. The end of the analysis of Bill 677 by the Health Committee of the Chamber of Deputies without proposing necessary amendments points to a slow process and the rejection of the bill or its passing in a version with rules below those necessary for the effective and safe implementation of this alternative for the incorporation of technologies into the SUS. Therefore, now is a good moment for both civil society (exceptionally patient associations) and the industry to engage politically and breathe new life into Bill 677, with the necessary critical reflection on the current state of its text.