| Biogen Brazil
Biogen Brazil
Our team is built only with senior legal and compliance professionals. Although our business is not a start-up, we operate with a reduced number of colleagues in each affiliate. Being nimble makes us work faster and smarter, allocating our resources on strategic / high-end matters, whereas the simplest matters are outsourced to our outside counsels or structured in a self-service methodology where feasible. In Brazil, I serve as the legal and compliance officer with a director role, overseeing all legal and compliance related functions, as well as serving the company locally as part of its leadership team. I have a direct report line to my direct leader, the Latin American legal and compliance officer.
I have a manager which is a senior legal professional in charge of all governance and compliance matters in the affiliate, supporting the business and the board with the operational and tactical affairs of the affiliate.
In the past, we used to have third party staff working in our offices, but we’ve realized it is more suitable for our organisation to outsource the work directly to specialised attorneys when necessary instead of a generalist profile. Not only are we seeing savings and efficiency in operating in this manner, but this also empowers us to a more modern framework, prepared for future changes to come in our legal profession.
There are two perspectives to frame this answer. Legal can always show value when a novel alternative is being discussed, on occasion in which the value of legal advice becomes self-evident. However, in situations when you are mitigating risks which are not easily measurable or quickly perceived, then a problem surfaces. In these situations, my personal experience shows that storytelling on a clear manner how the risk assessment is built and where your advice is coming from is always a game changer. People are clever to understand the logic when you point then in the right thought process direction. Also, avoiding legal wording goes a long way to avoid sounding presumptuous.
Definitely, and as part of the leadership team, the legal and compliance officer plays a pivotal role in formulating this agenda, especially because this is of a legal concern in Brazil. We do not tolerate discrimination in any forms in our company. We respect each other’s individuality and believe that a diverse group is a fundamental ingredient to our success.
The Brazilian data privacy and protection rules definitely imposed an agenda for the organisation. We have established this as one of the most important projects for the affiliate, especially because it deals with a cornerstone of our organisation: being responsible, ethical and customer-focused. Moreover, the tax reform should also play an important role.
Risk sharing agreements with public payors: Pathway to a sustainable and state of the art universal healthcare system.
With new promising therapies bringing renewed hope for patients faster by the day, so does the concern of public and private payors with the system affordability. The existing cost vs benefit ratio has never been an object of concern as it has been in recent days, even for systems considered industry benchmarks.
Said concern is escalated by patients and associations which are pushing more and more for systems with more quality, transparency and faster adoption rates on new technologies. Naturally, the pressure is also felt by the industry, which has not stood idle on this.
Although not new, one of the solutions to reduce the financial impacts that is receiving increased attention in the healthcare environment is the adoption of risk sharing agreements (RSA). In short, RSAs are agreements in which both manufacturers and payors share the financial risk of the supply and/or service, whereas the outcomes can be determined based on financial drivers or clinical based criteria. The financing of these models can be done in various formats, such as capitation, portfolio or ordinary rebates (whether in cash or equivalent).
The rationale behind this non-standard model varies, but are mainly driven by competitive pressures, the need to obtain scale to offset significant investments, cost efficiency with non-recurring treatments, boost confidence levels and building deeper, transparent and purpose driven relationships, with a true commitment to social and corporate values. In short, the potential benefit of RSAs goes way beyond financials goals, which are more and more relevant for the industry and for the society.
Nevertheless, RSAs are far more complex agreements, that require significant time and effort to be developed before being brought into life.
Usually, finance-based outcomes are not entirely difficult to understand and hence, there are set boundaries of minimum/maximum pricing, volume and patients. The formulae might change depending on the therapeutical field and/or product portfolio, but generally takes into consideration discounts, caps or products donation, whereas the parties set caps or limits on the amount of spend per product or patient.
Outcomes-based agreements are far more complex, since depending on the therapy, the midpoints and endpoints to determine a successful treatment can be extremely complex. More commonly known diseases can be far less challenging than rare diseases or those that require a multidisciplinary approach from a medical perspective.
That considered, it is simple to state that RSAs are not available for all therapies in the market and must be considered depending on the maturity of each market and its characteristics. As reference, mostly developed countries are engaging in this type of model, whereas developing countries are yet to follow at a more robust pace.
It is exciting to see when countries such as Brazil are moving towards that direction, whereas the Ministry of Health is pioneering with the industry to offer a rare disease drug to its population under the universal healthcare system.
It is even more amazing to realise that both the federal government and private companies are willing to combine efforts for the first time in the history of the continent, to build this in a RSA that unifies both finance and outcome driven criteria. This shows how otherwise apparently different interests can find a common path when the challenges and opportunities are addressed in a transparent manner. This not only reveals a great concern for patients but also a significant and real effort to bring quality and effective drugs to patients – no matter how costly the drugs are or how few the patients may be.
This is a legacy and a statement for younger generations, where one can hope that a universal healthcare system does not anymore rely entirely on scientific innovations, but also on pioneering new business models and perspectives.