År: 2017 // Anslagsförvaltare: Uppsala universitet //
Område: Rättsvetenskap post doc // Belopp: 1 715 000 kr
Vetenskap och beprövad erfarenhet – Att sträva efter patientsäkerhet och vetenskaplighet i klinisk praxis
Under drygt ett halvt sekel har rättsliga krav på vetenskap och beprövad erfarenhet inom medicin tjänat som en tröskel för att garantera att svensk hälso- och sjukvård är effektiv och säker för patienterna. Tack vare detta krav har den svenska medicinska rätten betraktats som en av de mest avancerade och vetenskapliga i världen. Ett antal skandaler med tragiska utfall har dock pekat på problem gällande förståelsen för och tillämpningen av rättsnormerna. Av min avhandling framgår att dessa tragedier hade kunnat undvikas om reglerna hade tolkats och tillämpats på ett korrekt sätt.
Mitt projekt syftar till att utveckla begreppet vetenskap och beprövad erfarenhet så det i framtiden bättre ska kunna tjäna som en garanti för patientsäkerhet och klinisk effektivitet. För detta krävs att två konkretiseringar görs. Dessa är (1) utveckling av begreppets innebörd och ett säkerställande av hur begreppet tolkas och tillämpas i sin rättsliga kontext, (2) utarbetande av tydliga riktlinjer för hur de rättsliga kraven ska mötas i klinisk praxis.
Först när dessa krav har konkretiserats kan det garanteras att patienternas säkerhet skyddas, och därigenom kan det rykte som svensk medicins åtnjuter upprätthållas. Rätt utvecklat har kravet på vetenskap och beprövad erfarenhet även potential att tjäna som en framtida global standard för patientsäkerhet och evidensbaserad klinisk praxis.
Mer om forskningsprojektet
For more than half a century, Swedish law has designated vetenskap och beprövad erfarenhet as a threshold for safe and effective health care. Since 1963, physicians in Sweden have been required to adhere to that standard in medical practice with few exceptions, an obligation extended to all health care personnel in 1994. The standard also reverberates normatively throughout Swedish law. It is the underlying principle behind restrictions in the Patient Injury Act, which limits compensation for injuries to cases of high probability that any harm from medical care could have been avoided through less risky measures – an assessment that, according to the preparatory works to the law, primarily concerns deviations from vetenskap och beprövad erfarenhet. In criminal law, the standard determines when medical interventions can be confirmed to treat injuries rather than cause them, particularly, for example, when cutting into the body or removing organs, which would otherwise be prohibited without a scientifically valid therapeutic purpose. The standard also clarifies when a particular treatment can be classified as experimental – a determination that is critical to ensure that nonconsensual experimentation on human subjects is not taking place in Sweden in violation of international human rights law.
Unfortunately, recent controversies in Sweden have emerged from failures to adhere to vetenskap och beprövad erfarenhet in clinical practice, with significant damage to Sweden’s international reputation in medical science. The current crisis at Karolinska Institute (KI) surrounding the use of experimental medical devices on patients is only partially due to alleged scientific misconduct of its lead researcher and institutional failure to apply for ethical approval for the work. As the first formal investigation of KI concluded, the crisis at the hospital arose because of a practice that blurred the boundaries between experimentation and clinical practice. This past year, it has also become clear that problems of this sort are not confined to KI, as similar practices have been identified at Akademiska Sjukhuset in Uppsala. Consequently, the government has now called for an investigation to reassess the bounds between experimentation, research, and clinical practice in Sweden, with the first report due sometime in 2017.
Though it is problematic to assert that recent controversies in Sweden are symptomatic of deeper problems in our health care system, there is cause for significant concern that clinicians here, as elsewhere, may deviate from vetenskap och beprövad erfarenhet when vulnerable groups of patients are under their care, especially in pediatrics where treatment decisions are made on the basis clinical and parental judgment, in theory on the basis of data. In 2012, for example, the Agency for Fundamental Rights (FRA) for the EU criticized Sweden on human rights grounds for its involuntary psychiatric care practices. In 2015, a government investigation within Sweden confirmed that several practices involving involuntary commitment of minors have rested on questionable science. Similarly, the FRA has directed criticism toward Sweden for permitting gender assignment and “normalization” surgeries on infants with intersex conditions. For years, Sweden’s leading experts in the field have acknowledged that long-term data confirming the safety and efficacy of these procedures does not exist, but no action has been taken to stop them – either by clinicians or the government – even though several agencies from the UN, the Council of Europe and the EU have called on all nations to prohibit these measures as inhumane and degrading treatment.
Problems such as these signal a need for a broader investigation of how medical interventions are being validated for lawful use in clinical practice in Sweden. This is particularly true if vetenskap och beprövad erfarenhet is, as theorized, not only intended to promote safe and effective care for all patients, but one that may be necessary to protect vulnerable patients from care that is not scientifically sound.
The proposed project is based on the hypothesis that vetenskap och beprövad erfarenhet, as a rule of law, requires careful testing to determine its own functionality, much as any scientific hypothesis does. This is particularly appropriate as the standard itself scientifically endorses the principle that careful testing is required to validate clinical practice – a standard that should apply to the law as well. The project, therefore, will test the validity of vetenskap och beprövad erfarenhet as a clinical practice concept in three ways. First, it will expand and deepen my prior legal analysis of the concept to explain how it works systemically in Sweden and how it should function theoretically in cases where scientific support for treatment is contested. Second, it will provide extensive analysis of evidence-based medicine and competing models for scientific validation of medical interventions, so that these models can be compared to vetenskap och beprövad erfarenhet. Finally, it will test the application of vetenskap och beprövad erfarenhet as legal criteria through analysis of systemic reviews of evidence in medical literature, identifying a range of interventions where clinicians are concerned about the risk-benefit calculus of proposed treatments. The project will focus on pediatric care, in part because children are particularly vulnerable in health care, but also because patient choice rarely affects the outcomes in the decision-making process regarding the interventions studied.
The overarching goal of the project is to produce quality legal analysis of the rule in its juridical, systemic context so that the law is better understood. As the aim of the law is to secure clinical practice from harm to patients, it also must result in illustrations for how it should be used by clinicians, which may be developed into guidelines.