A legal compass to navigate health systems transformation?

Legal frameworks: securing value for money through building back better

Countries committed to progressing towards universal health coverage (UHC) as per the Sustainable Development Goals (SDGs) increasingly condone a Health Systems Transformation approach as the only strategic orientation to drive significant and operational progress.

This is in particular to : strengthen service coverage ; improve access to health services; protect against financial risks linked to access to those services ; and increasingly strive to provide better quality of service.

Since the design, planning, regulation and organisation of health systems are falling within the jurisdiction of public authorities, governance is at the nexus of health systems transformation. A multifold concept, Governance is defined by the Asian Development Bank as « the manner in which power is exercised in the management of a country’s economic and social resources for development”.

Applied to the health sector, this entails that policy and decision makers are entrusted powers to organise and deliver a number of benefits, underpinned by a range of capabilities, whether in scientific and clinical areas or in management, financial, and legal areas.

Against this backdrop, legal frameworks prove essential to provide clear, stringent dynamics to organise and transform health systems from the design stage of norms to the delivery of services and benefits to the final users.

To paraphrase a fine British Comedy, one has a feeling that « law, actually, is all around us ».

Health Systems transformation: Law actually is all around us

In broad terms, the rule of law proves essential to bolster and operationalize health transformation to secure value for money across health choices.

This is best illustrated by the variety of areas that require the support of branches of law such as those mentioned hereunder:

- Constitutional law to define which authorities are entrusted with normative and regulatory roles as well as to scope out the extent of potential rights to health granted to individuals.

Public law in general will provide for administrative and judicial appeals against decisions which will affect health services users.

Moreover, the protection of fundamental rights falls within this jurisdiction, calling for legal expertise to help strengthen users’ rights which can range from right to access to care to confidentiality, fair treatment, transparency of decision, etc.

- Administrative law to understand the devolution of powers of organisation, planning and delivery of public services and the interactions between stakeholders (e.g. decentralisation of health services ; collaboration between the ministerial departments in charge of health, social affairs, and finance ; or else the overlaps between ministries in charge of infrastructure, energy and health to strengthen health infrastructure while ensuring that these assets comply with different sets of norms)

- Environmental law and the array of increasingly stringent norms to encourage healthy behaviours and environments, while promoting health a!nd limiting emissions of pollution.

Public law will define the extent of the environmental norms and regulations will also impact the way that the health sector abides by these norms (think medical waste treatment or the recycling of nuclear waste in oncology/radiotherapy centres, a trend which is increasing across regions)

- Public business law and contracting will also provide the organisational and managerial instruments to collaborate across public and private stakeholders: procuring goods, assets, commodities, drugs, technologies or bioequipments require contracting.

The Public-Private Partnerships (PPP) agenda which pertains to procurement and public contracts also demands strong health stewardship skill mix across long term projects’ lifecycles and thus robust legal capacities for public health stewards teams

- Tax law will determine the course of health financing as well as budget allocation rules that will apply to the health sector: domestic funding for health or fiscal space for health rely primarily on the vehicle of tax law which has to be navigated by health policy makers

- Legislative and regulatory techniques to help countries’ authorities regularly update, approximate, ensure coherence of the rule of law as entrenched in laws and regulations, across areas pertaining to the health sector development.

The above do not preclude considerable influences yielded by other branches of law such as  international trade law, criminal law or tort law or the law of civil/public responsibility, exemplifying the necessity for health transformation strategies to be backed by legal capabilities in order to prove effective.

Legislation & Governance: how can we help?

Delving into the particularities of disease-oriented or emergency and preparedness-oriented teams, the following points can illustrate areas of collaborations:

Diseases teams

- Setting-up and operationalising supervisory, regulatory and organisational body to deliver health services

- Ensuring health master planning through licensing, organisation of clinical and ancillary services delivery through health facilities

- Setting norms and standards across diagnostics, analyses, laboratory and clinical functions

- Providing legal frameworks in the field of intellectual property (e.g. TRIPS)

- Securing effective rights of access, transparency, respect of confidentiality and integrity of users’ data

- Providing frameworks for priority settings, benefit package design and HTA that ensure conflicts of interest are avoided ; decisions are compliant ; appeals can be made ; ethics and societal values are respected

- In the case of preventable diseases, law and regulations can help HSS teams encourage healthy behaviours, prescribe bans (of alcohol and driving or smoking in the public place, or impose plain packaging for tobacco products) as well as use tax to stimulate healthier behaviours 

- Bolster value for money through contracting, procurement and engagement of public and private health providers.

Emergency and preparedness teams

- Emergency and preparedness team will find legal capabilities useful to ensure regulations at time of outbreaks as well as ensure access to services is prone to equity and nondiscriminatory

- The implementation of International Health Regulations is another important aspect of the WHO work calling for close collaboration between legal experts and implementers of IHR

- In terms of prevention of risks, Occupational Health and Safety, particularly important in some segments of the economy (chemical, petrochemical or mining or transportation sectors to name a few) also need legal inputs and perspectives

- The legal skills of updating, approximating laws and regulations across regions or groups of countries can also prove instrumental to optimise the organisation of responses to emergencies.

Digital health

When thinking about health systems transformation and innovation, the whole spectrum of digital health springs in mind. This entails more specifically:

- data harvesting, processing and protection: your Decide Hub informs you regularly of the dangers looming over the collection and circulation as well as storage of personal data pertaining to health status or conditions (click here for a recent illustration). Legal protocol, norms and a paraphernalia measures of criminal offences still seem to lag behind the digital ability of criminals

- e-health and m-health requiring strong legal boundaries, protocol definition (including but not limited to right of access and management to personal data, protection against cyber attacks and use of digital public domains)

- the use of blockchain and token techniques in the Health Technology Assessment will help redefine the legal review, right of appeal before administrative authorities or the Judiciary against whole or part of the HTA process.

By ensuring compliance of policies to normative frameworks in place or adapting legislation and regulations to the new objectives of health policies, decision makers and health stewards can strengthen the effectiveness of their health agenda, optimise its operationalisation and ultimately deliver value for money over the policy life cycle.