Failure to comply with Certificate of Need requirements will result in a fine or five years imprisonment or both, writes SAMJ News Editor Chris Bateman.

The CoN will have far-reaching, unintended consequences and the doctor bodies are afraid this could undermine its commendable intentions.

The associations are fully behind the government’s objective to improve access to healthcare, particularly in more underserved areas.

However, they believe that as the CoN currently stands that it is a clumsy legal instrument that could so disadvantage health care providers and patients – and worsen, rather than improve access to services.

The country’s largest representative doctor body, the South African Medical Association (SAMA); the South African Dental Association (SADA); and the largest private specialist body, the South African Private Practitioners Forum (SAPPF) have banded together to urgently engage government to create a more universally beneficial outcome.

Other bodies, like the Hospital Association of South Africa (HASA), are conducting rapid research in relevant fields before possibly joining the doctor initiative

Several of the relevant sections of the National Health Act remain unclear. The entire law gives unfettered power to the Director General of Health, a position currently occupied by Precious Malebono Matsotso, to effectively decide where all health care providers, facilities and medical equipment may or may not operate or practice. The term “medical equipment” remains undefined. The instrument for this is the CoN.

All health care “establishments,” i.e. places where healthcare is rendered and including all practices have until 1 April, 2016 to apply for it.

Doctors bodies are asking to be intimately involved in drawing up the regulations that are to be drafted as part of a ‘consultative’ process before 1 April 2016. The associations are hoping their involvement will mitigate the alarmingly prohibitive constraints proposed for doctors and patients.

What the law says…

A CoN will be required for:

1. Anyone establishing, constructing, modifying or acquiring a health establishment or agency;
2. Increasing the number of beds in, or acquiring prescribed health technology at a health establishment or health agency;
3. a) Providing ‘prescribed’ health services; or b); continuing to operate a health establishment or health agency after the expiration of 24 months from which date the relevant addition to the Act took effect, or 1 April 2014.

The Act also requires the Director General of Health or a designated representative to apply their minds to a host of requirements before issuing a certificate.

These requirements range from the equitable distribution and rationalisation of services and resources, to taking into account the demographic and epidemiological characteristics of the population to be served.

Road to final enactment filled with potholes.

Examination of the resuscitated law by the three doctor bodies – and the entire medical fraternity abuzz with anxious debate – reveals that it not only severely limits the health care providers’ rights, but arguably those of patients in accessing care and medical information. It could render existing medical businesses worthless and create a mountain of red tape with a huge and expensive bureaucracy.

Practical administrative issues like selling a practice or taking on partners, and the clashing of the CoN with at least six other existing laws, including the Consumer Protection Act, the Promotion of Access to Information Act, and the Promotion of Equality and Prevention of Unfair Discrimination Act, pose major problems.

The CoN also conflicts with constitutional provisions protecting freedom of movement and association, which is likely to render the consultative process tricky and longer than the actual law permits.

SAMA’s perspective

[quote float=”right”]Many hospitals are run by “people with little or no idea about medicine and healthcare delivery”

SAMA Chairperson Dr Mzukisi Grootboom added that the CoN could create perverse outcomes.

“Will it affect only newcomers to the system or those already practicing?” Grootboom asked. “It’s quite clear, from the way it’s written that everybody practicing will have to get a CoN just to justify their existence and where they practice.”

Failure to comply will result in a fine or five years imprisonment or both.

Grootboom added that among the CoN’s potential unintended consequences were the closing of practices and the denial of care to existing populations.

An examination of the equivalent US law showed that it was used to adjudicate on aspirant health care facilities in order to avoid over-concentration of services and expensive equipment in one area.

SAMA was “completely behind” improving access to health care in South Africa’s underserviced areas, but it did not believe the CoN was the only instrument to use, he said.

Can the CoN be one of the instruments?

The answer is theoretically maybe, based purely on whether it’s practical. But what remedies are in place to address the host of unintended consequences?

Grootboom said that besides anecdotal evidence, there was ample research to show that remuneration, such as Occupation-Specific Dispensation (OSD) and rural allowance incentives, alone did not retain health care. This emerged from the Health Departments’ own White Paper on Human Resources for Healthcare.

The experience of SAMA’s public sector members is that “the terrain out there is extremely unsupportive to doctors,” Grootboom said.

Besides drug stock-outs, lack of instruments and supervision and the scarcity of subsidised accommodation, many hospitals are run by “people with little or no idea about medicine and healthcare delivery,” he added.

“They’re only interested in keeping within a budget,” he said. “Service delivery is neither here nor there to them.”

[quote float=”left”]”Please involve those of us who deal with patients on a daily basis instead of controlling us from the outside”

Grootboom pleaded with government to sit down with stakeholders, evaluate possible instruments to use and ensure the health care system becomes responsible to population needs.

“Things like creating more viable campuses in the more rural provinces and retaining high level teaching staff…” he said. “We need to make sure people have a reason to stay there.”

He cited the Thai model where most training centres are now in under-serviced, outlying areas, attracting high-level expertise.

He said the government had an unfortunate track record in partnering with doctors to find solutions.

“A lot of us are sensitive to what the African National Congress and the government are trying to achieve in addressing disparities – and they’re bound to make mistakes,” he said. “We need to rise above petty squabbles and let them know they have our support – but please involve those of us who deal with patients on a daily basis instead of controlling us from the outside.”

Grootboom said he had spoken to Matsoso, who said the CoN was needed to empower the new Office of Healthcare Standards Compliance, (OHSC), a core component of the National Health Insurance. OHSC inspectors will be evaluating facilities on whether or not they have CoN as part of their work.

Matsoso had conceded to him that there “might be constitutional problems which need addressing,” but whatever reassurances she made, “what’s written (in the new law) is what’s written”.

According to a top constitutional lawyer in the healthcare field, Elsabe Klinck, no standards have been issued for various types of practices in the private sector yet. The Health Department must first climb a mountain of administration before these can be promulgated, let alone have the OHSC conduct inspections and then go through CoN applications for thousands of establishments.

Health Department Spokesman Joe Maila reflected Matsoso, and was quoted by Health-e News as saying “nothing is going to be unilateral, adding that it would be unconstitutional to force doctors to work in places where they did not want to.” He promised that “nothing will be done without full consultation”.

The dentists view…

[quote float=”right”]“I’m constantly amazed at the decisions taken without an understanding of the risks attached and a comprehensive analysis of the downstream impact and potential of where things could go wrong”

SADA CEO Maretha Smit said doctors and dentists cared about South Africans and wanted to partner with government in addressing the principle of universal access to health care. However, she called for better communication.

“We’d like to ask that this be consistent, constructive and solutions-driven and to include engagement with the professions,” Smit said. “To alienate the professions simply means that government won’t be able to reach their target.”

She said that on a “cold reading of the Act we are fundamentally affected – but when you speak to Health Department representatives they take a much more pragmatic and conciliatory approach, even admitting they don’t have the resources to look at every individual practice.”

Smit said the professions were “crying out for a carrot approach”.

“We’re talking about people who went into a certain profession because they care,” she said. “I get the sense from my members that they really want to make an impact on providing health for as many people as possible.”

According to Smit, there appeared to be an official lack of understanding of the difficulties inherent in the practice environment. The focus for practitioners had turned from how best to provide care to how best to survive.

“If we take the, ‘how do I survive’ out of the equation, you’ll get a lot more people saying, ‘how do I care?” she stressed.

South Africa’s health care problems seemed not so much about ideology but execution.

“I’m constantly amazed at the decisions taken without an understanding of the risks attached and a comprehensive analysis of the downstream impact and potential of where things could go wrong,” she said.

Smit warned that this could result in a dramatic downturn in people wanting to enter the healthcare professions, with dire national implications.

Private doctors’ body speaks…

[quote float=”right”]“If the Director General decides there are too many gynecologists in my hospital and wants to spread elsewhere, she won’t issue a certificate for my practice and I’ll have nothing to sell”

SAPPF CEO Dr Chris Archer echoed Grootboom, saying that “we have to look at the Act itself, not the interpretation of the Act by the Director General”.

He also emphasised that the SAPPF was not in opposition to the government’s ultimate objective, but to the methodology used in getting there. In terms of the act, the CoN definition of a health establishment included established practices. It raises questions for health professionals looking to retire or pass on family businesses.

“What about when I want to retire and sell my practice?,” Archer asked. “If the Director General decides there are too many gynecologists in my hospital and wants to spread elsewhere, she won’t issue a certificate for my practice and I’ll have nothing to sell.”

“The same applies to father and son, mother and daughter, coming into a practice,” he added.

The concept of a third party determining one’s fate ‘because they have the power to do so,’ was a ‘complete anathema’ to the SAPPF.

“Even if they are magnanimous, they still have the power…and what happens when the Director General or the Minister of Health changes?’ he asked.

Archer described the CoN promulgation as “very worrying indeed,” but said he took some comfort in the vastly increased accessibility of the Minister of Health and his Director General, compared to when the law was first mooted.

This is an edited version of a piece written by Chris Bateman for the South African Medical Journal and to be published in the journal’s next issue. The journal is published by SAMA.