Selena Gomez and the kidney transplant: who guarantees the medicine and the follow-up after discharge

English translation of an article first published in Portuguese: read the original.

On 14 September 2017, Selena Gomez said on Instagram that she had needed a kidney transplant because of lupus, that she was recovering and that the donor had been her friend, the actress Francia Raisa, whom she thanked publicly. The Associated Press recorded the announcement: her representatives confirmed the post, said she had spent the summer away in order to recover and gave no further details; neither the place nor the date of the surgery was disclosed. The diagnosis of lupus, an autoimmune disease in which the body attacks its own tissues, sometimes the kidneys, she had made public in 2015.

The account is hers, and nothing is stated here about the artist’s doctors, services, medicines or current state of health. It is of interest for a part that no transplant announcement shows: the afterwards. Donation between living persons has rules of its own, dealt with in the article on the kidney from a living donor (in Portuguese). Here the question is a different one: after discharge, who guarantees the medicine that prevents rejection and the follow-up that adjusts that medicine, and what to do when one of the two fails.

The answer begins in December 1954. According to the presentation speech for the 1990 Nobel Prize in Medicine, Joseph Murray performed the first successful kidney transplant between identical twins, because there were reasons to suppose that between them the immunological barrier did not exist; the first recipient was Richard Herrick. For the other patients, the body rejected the organ. Transplantation between non-identical relatives and of kidneys from deceased donors only succeeded when drugs such as azathioprine began to contain rejection. Since then, the new kidney has depended on a medicine taken every day, and the right to the transplant depends on the right to what comes after it.

Lupus, the kidney and what the transplant does not bring to an end

When lupus affects the kidneys, one speaks of lupus nephritis, and the risk of the kidneys ceasing to function is measurable. A systematic review with meta-analysis by Tektonidou, Dasgupta and Ward (Arthritis & Rheumatology, 2016), which gathered 187 publications and 18,309 patients, showed that, in developed countries, the five-year risk of end-stage renal disease fell from 16% in the 1970s to 11% in the mid-1990s and then stabilised. The fifteen-year risk was higher in developing countries, and class IV nephritis reached 44% at fifteen years in the 2000s. The authors read the plateau as a sign of limits in the efficacy of treatments or in access to them. The KDIGO international guideline on lupus nephritis was updated in 2024 precisely because two new drugs had been approved since the previous edition (Kidney International, 2024).

For those who reach kidney failure, transplantation is the option of choice. The Brazilian protocol on immunosuppression in kidney transplantation records that, compared with dialysis, it “provides better survival, better quality of life and lower cost in the long term”. The natural doubt is whether lupus comes back in the new kidney. A registry study by Contreras and colleagues (Journal of the American Society of Nephrology, 2010) examined the records of the US transplant network (UNOS) for 6,850 people with lupus transplanted between 1987 and 2006. Recurrence of lupus nephritis in the graft had a prevalence of 2.44% over the period, more frequent in non-Hispanic Black people, in women and in those under 33.

The figure that matters most to the subject of the article comes next. Recurrence multiplied the risk of graft loss fourfold compared with patients without rejection, but only 7% of graft losses were attributed to it, against 43% attributed to rejection. The authors concluded that these findings should not keep people with lupus away from transplantation. Translated into law: the main enemy of the transplanted kidney is not the underlying disease, it is rejection, and the defence against it is a regimen of immunosuppressants taken without interruption and adjusted by periodic tests. These are population data from another country; they say nothing about a given patient, but they show where the avoidable risk lies.

Adjustment is part of the treatment, not a detail. The Brazilian protocol requires the doses of tacrolimus and ciclosporin to be adjusted regularly according to their concentration in the blood, and recalls that levels “incompatible with the usual ones recommended in this Protocol may indicate inadequate use” of the medicines. The blood-level test is therefore the instrument that turns a prescription into treatment. A patient who has the medicine but not the test is taking a dose blindly; one who has the test but not the medicine is exposed to rejection.

The Brazilian protocol: a treatment that does not stop

In the SUS (Brazil’s public health system), the roadmap is in the Clinical Protocol and Therapeutic Guidelines (PCDT) on immunosuppression in kidney transplantation, approved by Joint Ordinance SAES/SCTIE No. 1 of 5 January 2021, with its annex amended in 2022. The monitoring section contains the sentence that sums up the legal problem: “the surgical act is only the first stage of a treatment and that inadequate control may compromise the results”. For stable patients, it recommends visits twice a week in the first month, weekly from the second to the third month, fortnightly from the fourth to the sixth, monthly from the seventh to the twelfth, and every two or three months after the first year.

The same document fixes the duration: “Treatment with immunosuppressive drugs must be maintained for as long as the patient is alive and the graft is functioning”. It recommends that transplant recipients be followed regularly by trained professionals, “preferably in services accredited by the Ministry of Health, forming part of the National Transplant System”. It makes it mandatory to inform the patient of the risks and side effects of the medicines, by means of the Statement of Information and Responsibility (Termo de Esclarecimento e Responsabilidade) (art. 2 of the ordinance). And it directs state, Federal District and municipal managers to structure the care network, define the reference services and establish the care pathways (art. 3).

A practical consequence follows. Whoever is discharged should leave knowing which service will follow them, on what dates they come back, where they have the blood-level test and where they collect the medicine. If they leave without knowing, the failure has already begun, even though nothing has gone wrong in the body, because the protocol made follow-up part of the treatment itself.

In the SUS: the Transplants Act ends at the surgery, the medicine comes through another door

Lei 9.434/1997 (the Transplants Act) deals with the before: who may donate while alive (art. 9), the recipient’s consent and registration on the single waiting list (art. 10). Decreto 9.175/2017, which regulates it, establishes the National Transplant System, “within which the process of donation, removal, distribution and transplantation shall take place” (art. 2), made up of the Ministry of Health, the Health Secretariats and the Transplant Centres, among others (art. 3), and assigns management of the single list to the Ministry (art. 5, VIII). The decree does not mention immunosuppressants. The right to what comes after the surgery lies elsewhere in the legal system.

It lies, first, in Lei 8.080/1990 (the Organic Health Act), which includes within the SUS’s field of action “comprehensive therapeutic assistance, including pharmaceutical assistance” (art. 6, I, “d”), and defines that assistance as the dispensing of medicines “whose prescription is in accordance with the therapeutic guidelines defined in a clinical protocol” (art. 19-M, I). The kidney transplant protocol is that document, and it states that tacrolimus, ciclosporin, mycophenolate, sirolimus and everolimus, among others, form part of outpatient procedures of the CEAF (the specialised component of pharmaceutical assistance). Brazil, according to the same text, is the second country in the world in absolute number of kidney transplants, performed 113,032 of them between 1964 and 2019, had around 70,000 people in follow-up with a functioning graft and is a “world reference in public funding of transplants”, from the pre-transplant stage to the distribution of immunosuppressants.

The route for the medicine is on the official CEAF page: prescription with the specific report form (LME), application at the reference pharmacy, technical assessment “of the initial application or of the renewal for continuation of treatment” and dispensing. “The health secretariats of the States and of the Federal District are responsible for receiving and assessing applications and for dispensing CEAF medicines.” The institutional address is known: if tacrolimus is lacking or the renewal has not been assessed, the request is directed not to the hospital or the physician but to the State Secretariat, in writing and with a protocol number; and the transplant team needs to know the same day, because only it decides the clinical course of action while the impasse lasts.

The distinction between an incorporated and a non-incorporated medicine changes everything. For the immunosuppressant that is in the protocol, the obligation is administrative and already exists. For one outside the lists, the thesis of the STF (Supreme Federal Court) in Theme 6 (RE 566.471) applies: non-inclusion “prevents, as a general rule, the supply of the drug by court order”, save for an exception with cumulative requirements, among them an administrative denial, the impossibility of substitution by a medicine from the protocols, high-level evidence and inability to pay; the route is set out in the guide to the SUS (in Portuguese). The arsenal is under review: in 2026, Conitec (the national health-technology assessment committee) put out for public consultation proposals on induction, maintenance and the treatment of rejection. In the preliminary report of Public Consultation 75, the initial favourable recommendation for five medicines for rejection was based on the need to “preserve graft function and avoid retransplantation”; in that of Public Consultation 68, alemtuzumab received a preliminary unfavourable recommendation for induction in kidney transplantation.

And those who have a health plan

Lei 9.656/1998 (the Health Plans Act) excludes from the reference plan the “supply of medicines for home treatment” (art. 10, VI), and the exceptions the law itself opens are for oral antineoplastics (art. 12, I, “c”, and II, “g”), not for immunosuppressants. The health plan, therefore, is not obliged by law to deliver tacrolimus for use at home, and the medicine, for those with or without a plan, comes through the SUS, which dispenses it to whoever meets the protocol. The plan is obliged, in the outpatient segment, to provide “medical consultations, in unlimited number” and “diagnostic support and treatment services and other outpatient procedures, requested by the treating physician” (art. 12, I, “a” and “b”): that is where the return visits to the nephrologist and the blood-level and kidney-function tests lie.

A consultation with a specialist has a maximum waiting time of fourteen working days (RN 566/2022, art. 3, II), with a mandatory protocol number (art. 12). In a follow-up that the clinical protocol provides for weekly or fortnightly in the first months, the full diary of the accredited network is no detail: when the indicated return visit does not fit within the deadline, the denial or the delay must be recorded, because that is what is argued with the operator. The change of manufacturer of the medicine, another sensitive point, is dealt with in the article on the laboratory that stopped making the medicine (in Portuguese).

Comparative law: three ways of paying for the graft’s medicine

1. United States: the medicine that had a time limit

In the United States, those who had Medicare on account of end-stage renal disease lost that coverage 36 months after the transplant. The 2021 budget law (Consolidated Appropriations Act, 2021) created a specific benefit, Part B-ID. According to the federal agency that administers the programme, since January 2023 it has covered immunosuppressive drugs on a continuous basis, and those alone, with no other item or service, and people with certain other health coverage cannot enrol; the annual deductible and the 20% coinsurance apply. The American solution extended the medicine but left clinical follow-up outside the benefit and kept part of the cost with the patient.

2. Portugal: free of charge, but only through the hospital pharmacy

In Portugal, Despacho 6818/2004 (Order 6818/2004), in the version compiled by Infarmed, reimburses at 100% the medicines intended for the prophylaxis of acute transplant rejection. They may only be prescribed by specialists in hospital services, such as kidney transplant units, and are dispensed “exclusively through the pharmaceutical services of hospitals”; dispensing “is free of charge for the patient”, with the cost borne, as a rule, by the hospital where the medicine is prescribed. For the kidney, the compiled annex lists mycophenolic acid, everolimus, mycophenolate mofetil and sirolimus. The Portuguese model ties the medicine to the service that provides follow-up: whoever collects the immunosuppressant necessarily passes through the hospital that prescribes it.

3. England: the technology appraisal that obliges funding

In England, the NICE appraisal of immunosuppressive therapy for kidney transplant in adults (TA481, published on 11 October 2017) recommended basiliximab, immediate-release tacrolimus and mycophenolate mofetil as initial options, and did not recommend as initial treatment, among others, prolonged-release tacrolimus, sirolimus, everolimus and belatacept. Those already taking any of them were able to continue until patient and physician decided to stop. Under the rules cited in the appraisal itself, the NHS must comply with the recommendation within three months of publication. The appraisal also reproduces the warning of the British regulatory agency: oral tacrolimus should be prescribed and dispensed by brand, and switching brands requires “careful supervision and therapeutic monitoring” by a specialist.

The three countries show different paths. The American one funds the medicine but charges part of it and separates it from follow-up; the Portuguese one delivers it free of charge, but only within the hospital that provides follow-up; the English one decides by technology appraisal and obliges the system to comply. Brazil combines the protocol with the state pharmacy, with no expiry date for the medicine, and its weak point lies in execution: the pharmacy with no stock, the renewal at a standstill, the return visit that never gets booked.

When the failure is the system’s, and when it is not

A rejection can happen with everything done correctly, and the loss of the graft, on its own, proves no one’s failure. The legal question is narrower: was the follow-up provided for offered, and was the medicine prescribed in accordance with the protocol delivered? The multicentre ADHERE BRAZIL study helps to see why that question cannot be answered just by looking at the patient. In the analysis published by Marsicano-Souza and colleagues in the Revista de Saúde Pública in 2021, with 1,105 randomly selected kidney transplant recipients, 39.7% were not following the immunosuppressant regimen as prescribed, with variation from 11% to 65.2% between centres, and 13% had missed routine visits.

A follow-on analysis published by Karlburger and colleagues in Clinical Transplantation in 2025, with the same sample from 20 centres, identified what was associated with missed visits: being more than five years post-transplant (odds ratio 2.03), not following the immunosuppressant regimen (2.41) and, on the service side, monthly visits (1.75) and difficulty in scheduling (1.91). These are cross-sectional studies, with self-reported data, which show association and not causation. Even so, they dismantle the idea that failing in follow-up is merely a lack of discipline on the patient’s part.

The patient also has duties, and the law writes them down. The Patients’ Rights Statute, Lei 15.378/2026, requires the patient to share information about the medicines they take and to “inform health professionals of withdrawal from the prescribed treatment” (art. 22). Anyone who stopped taking the medicine on their own initiative and told no one will hardly have anything to complain about. The scenario is different when the patient went to the reference pharmacy and came back without the medicine, or asked for a return visit and could not get a date: there the obligation breached is that of the public body or of the operator, and the record of that attempt is the central piece of evidence.

In a health plan, the operator is liable for the services it provides regardless of fault, under the rule of art. 14 of the Código de Defesa do Consumidor (the Consumer Protection Code); in the SUS, liability falls on the body in charge of dispensing or of the service. If the graft is lost after a proven interruption, it will rarely be possible to state that the kidney would have been preserved without it; what is discussed is the lost chance. The STJ (Superior Court of Justice), in REsp 1.254.141/PR (Third Panel, reporting Justice Nancy Andrighi, judged on 4 December 2012), admitted loss of a chance in a case of inadequate cancer treatment and warned: “The chance, however, can never reach the value of the asset lost”. Expert evidence will have to say whether the failure altered the course of the graft, and the medical record, with the blood levels and the dates, is what makes it possible to answer.

Before deciding

In my view, the lack of an immunosuppressant for someone with a functioning graft should not be treated as just another queue, because the protocol itself says that this treatment does not stop, and the Brazilian risk lies less in the rule than in execution. Transplant recipients should leave discharge with the name of the service that will follow them, the schedule of return visits, the place for the blood-level test and the pharmacy for collection; keep prescriptions, LME forms, collection receipts and protocol numbers; notify the team the same day if the medicine is lacking or changes brand; and never suspend the medication without guidance. If a dispensing has failed, if the renewal has stalled or if a return visit has disappeared from the diary of the SUS or of the health plan, get in touch with the firm: the analysis starts from the protocol, the receipts and the answers received, and does not replace the transplant team.

About the author

Ramon Martins Andrade (OAB/RJ 188.374) is a lawyer who graduated from UFRJ in 2011, with master’s degrees from Université Sorbonne Nouvelle and from the Naval War College (EGN, Brazilian Navy). He is currently a researcher in Human Rights and Health at ENSP/Fiocruz.

This content is for information and education only. It does not constitute legal advice, advertising of results or any guarantee of outcome, under Rule 205/2021 of the Brazilian Bar Association (OAB).