Category: Latest

By Mark Heywood, Zain Rizvi

In May 2018, the Department of Trade and Industry (dti) finally unveiled a new policy that would help to rein in pharmaceutical industry profiteering. The Intellectual Property (IP) Policy of the Republic of South Africa, offered a fresh vision of how to improve medicine access. Phase 1 of this policy concentrated on issues to do with IP and public health. It recognized “the dire circumstances that ensue from lack of [medicine] affordability” and endorsed a range of measures to improve access. The policy was adopted by cabinet, and as such represents official government policy today.

The policy had been many years in the making. It was developed by an Inter-Ministerial Committee on Intellectual Property, debated extensively and arrived at via a thorough democratic process. It is in line with international law and recommendations made by the UN Secretary General’s High Level Panel on Access to Medicines. According to the policy its “aim is to ensure that South Africa protects IPRs and at the same time achieves its objectives of promoting national development imperatives, which include, among others, boosting local manufacturing, promoting innovation and ensuring equitable access to medicines.” It proposed a range of reforms, and new laws, that could make a real difference in people’s lives.

But the pharmaceutical industry has fought back.

On July 25, President Cyril Ramaphosa signed the Presidential Health Compact in a blaze of publicity. The Compact, which came into being after stakeholder consultations, promises a new commitment to fixing the public health care system. It includes a pillar on Access to Essential Medicines. Unfortunately though, pharma’s fingerprints have crept in, watering down the language on medicine access compared to the IP policy and raising concerns about expected new legislation. The Compact lists as one of its interventions:

“Finalise the South African National Policy on Intellectual property in a manner which balances the objectives of access with the need for IP protection to encourage pharmaceutical innovation, promote further research and development as well as attract future investment in the country.”

The suggestion here that the IP policy that Cabinet has adopted after an extensive democratic process is not finalized is either an error or an attempt to reopen the policy process through the backdoor. Either way, it is deeply concerning.

The Compact also seems to include new language and objectives. A few changes here and there may seem trivial. But these are not by any means innocent edits. They re-introduce tired and discredited arguments that could have profound health consequences, disproportionately counting in lives of the poor.

Let us explain exactly what we mean.

In South Africa, we have a growing cancer epidemic and cancer medicines provide a good example of what these words could do. The World Health Organization (WHO) has listed the drug lenalidomide, a treatment for multiple myeloma (a difficult and aggressive blood cancer), as an “essential medicine.” That means the WHO believes every health system should have it. We do not. Why? Because of its cost – a month’s treatment is priced at ZAR 60,000. A year’s worth costs ZAR 730,000.

In India, by contrast, a year’s course is available for less than ZAR 30,000.

What is responsible for this staggering difference? Why are cancer medicines often only accessible to the rich in South Africa?

The answer is prescription drug patents. Intellectual property blocks medicine access. Contrary to what industry claims, medicines are not expensive because they are costly to produce, or because they are expensive to research and develop. Medicines are expensive because of the monopolies that patents give their manufacturers.

In the case of lenalidomide, the patent-holding company in South Africa—Celgene—holds 32 patents that could block competition until 2028. This over-patenting is not unusual: a Fix the Patent Laws and Cancer Alliance report found the patents office had granted 92 patents on just 24 cancer medicines, delaying affordable generic access.

Unfortunately though South Africa does not examine patent applications before it grants them. Other countries, like India and Brazil, do. Among developing countries, the South African “system” is an over-patenting outlier. The consequences are unconscionable.

In early August, the Cancer Alliance sent a letter to Minister of Health Dr Zweli Mkhize that included a formal request that action should be taken by the government to ensure the affordability of lenalidomide. The Cancer Alliance is currently waiting for a response from the Minister. One action the Minister could take is to grant “compulsory licenses” on lenalidomide’s patents to authorize access to low-cost treatment. This is an important power to prevent patent abuses that is permitted by our existing laws but has never been used. It should be used and urgently accompanied with new laws that build on the reforms proposed by the 2018 IP policy and prioritize public health.

The IP policy that Cabinet has adopted is imperfect, but it is principled. It is grounded in the constitution, noting that when balancing private and public interests it must “first and foremost engender the ethos of the South African Constitution.” And, most importantly, it recognizes the “constitutional imperative to increase access to medicines” as a component of section 27 of the Constitution, which guarantees the right to access health care.

In contrast, the Compact’s language on access to medicines largely echoes industry talking-points, shifting the focus away from health. It designates two organisations—the South African Medical Association and Pharmaceutical Society of South Africa—as leading this work, none of which represent patients. It also presents false choices between balancing access, and innovation, research and development, and foreign investment. These have always been a distraction.

Cabinet has already recognized this. The IP policy, which cabinet approved, noted that there was “an inconclusive link” between increased IP protection and economic development, based on studies from the World Intellectual Property Organization and Nobel Laureate Joseph Stiglitz.

Similarly, a recent analysis found that less than 10% of the patents granted in the country over a decade were filed by people living in South Africa, undermining the claim that patents are linked to local innovation. In addition, South Africa accounts for less than one percent of the global pharmaceutical market. To suggest that South Africa’s efforts to increase access to medicines would impact global innovation is simply disingenuous.

We have been here before. In the early 2000s, HIV medicines were inaccessible to all but the wealthiest. Before the Treatment Action Campaign’s campaigns for affordable medicines a month of anti-retroviral medicines cost over R5 000. Today, the same medicines cost less than R500. In those days corporate profiteering, mixed with AIDS denialism, led to the preventable deaths of hundreds of thousands of people. Arguments about investment and innovation were trotted out to defend the indefensible. Today, nearly five million people living with HIV are alive and well because of access to affordable medicines.

But while we may have solved the problem of affordability for HIV medicines, we have not for almost every other illness. The root causes of high prices—unchecked patent-granted monopolies—remain in place. Once again, thousands of lives are being lost on the altar of profiteering. This is why South Africa must urgently adopt a new patent law. Many lives depend on it.

• Mark Heywood is the Editor of the soon-to-be-launched Maverick Citizen and former Executive Director at SECTION27. Zain Rizvi is a law & policy researcher at Public Citizen.

 

 

Housing the mentally ill in a condemned building with little security sounds like something out of a horror movie. But for the patients and staff of the Cecilia Makiwane Hospital (CMH) Mental Health Unit this is not a movie; it’s reality. The building, in the heart of Mdantsane, East London, is in disrepair: windows are broken, there’s exposed electrical wiring and abandoned medical equipment. There is no psychiatrist, security is virtually non-existent and staff and patients are traumatised.

While this regional hospital was reborn into a plethora of new beautiful buildings and facilities in March 2017, the Mental Health Unit was left in the decaying old hospital. The unit is not accessible from the new hospital gates and staff, patients and their families have to navigate the tricky side streets of Mdantsane to find the old entrance. If you’re lucky enough to find it, the security is abysmal; a friendly guard simply waves vehicles through without so much as a boot check or taking your name. There are no cameras and there’s barely a fence.

Parking is next to the ambulances; it appears that emergency medical services got stuck in the old building too, along with family medicine and an NGO.

The Mental Health Unit is made up of wards 11-15. You walk down the dark cement passageway; the old theatre is to the left and clusters of forgotten and decrepit medical wards to the right. Most of these wards have been closed off with rusty gates – some locked, others just appear to be. Old hospital beds and wheelchairs remain trapped inside these closed off passageways, along with overgrown grass and heaps of rubbish. By the time you reach the Mental Health Unit you wonder if anyone still works there, amidst the overwhelming neglect.

The unit is the only acute psychiatric facility in the Buffalo City Metro area, serving a population of over 755 000, with the next available facilities two hours away in Queenstown and Fort Beaufort.

Last year the unit made headlines in Eastern Cape community newspaper Grocott’s Mail as well as eNCA’s current affairs programme Checkpoint, as part of Health-e News’ two-part documentary series, The Writing on the Wall. Now, following a desperate plea from a whistleblower, a former staff member, Spotlight revisits the story.

Fire brings condemned hospital building to light

According to the source, a fire broke out in the female ward of the unit on 6 July. However, Eastern Cape Department of Health spokesperson Sizwe Kupelo disputed that there was a fire in the ward.

“What happened was a faulty microwave had an electrical fault and caused the microwave and nearby curtain [to catch on fire]. The fire did not spread to the building,” said Kupelo. The department blamed a “negligent” staff member.

Internal documents seen by Spotlight state that the fire was caused by faulty plugs in the unit, and that there had been two other electrical faults the following week. The documents highlight that the hospital’s management and infrastructure staff were aware of old electrical points, an issue that heightened staff concerns.

The former staff member claimed that firefighters could not enter the ward at the time of the emergency, due to its structural instability and lack of access points. According to documents seen by Spotlight, firefighters on the scene reported that the building was not up to safety standards and should not be in use.

Buffalo City Metro was approached for comment but did not respond by the time of publication.

The documents further reveal that in previous years the old hospital building did not acquire fire safety certification, forcing the department to build a new hospital. This information shocked staff, who had only heard rumours of the building being condemned.

Records show that members of hospital management, including the quality assurance manager and a senior manager in the Provincial Department of Health, knew for years that the old hospital was not safe.

However, Kupelo accused staff of using the fire to agitate for the relocation of the Mental Health Unit, and suggested that staff for that reason made allegations that the building was not safe.

“We used a specialist to assess the building safety including electrical installation and these are found to be within the acceptable levels,” he said.

Kupelo said the Head of the provincial Department of Health Dr Thobile Mbengashe had attended two meetings with staff and conducted in loco inspections of the facility.

“[The HOD] agreed with parties to move the remaining services at the old wing of the hospital and all parties agreed, including the doctors. The HOD made it clear that the priority is the safety and wellbeing of the patients.”

Spotlight posed immediate follow-up questions requesting clarification on where the remaining services would be moved but did not receive a response.

A follow-up meeting was scheduled for 29 July, but Spotlight cannot confirm if this meeting took place.

“It is unacceptable that the doctors take wide strike while the matter of the patients’ safety [is] being addressed,” said Kupelo.

Poor security leaves patients, staff at risk

Spotlight entered the facility with ease and, according to the source, other unwanted visitors do too. The whistleblower said vagrants were often found in the abandoned wards near the Mental Health Unit, which posed a safety risk to patients and staff.

Kupelo said that security issues would be immediately addressed, including installing security cameras, restricting and controlling access and ensuring that the entire facility is adequately fenced and secured.

The Mental Health Unit consists of two 25-bed wards – one for men and one for women. Both are medical wards that house acute patients with varying diagnoses. Some patients are dangerous and they are not separated.

On 16 June 2017, a revolt in the men’s ward resulted in serious damage to the facility and caused trauma for patients and staff. Police were called to intervene and patients were transferred to other institutions, mainly Tower Hospital in Fort Beaufort. Five days later, after hospital management and the Department of Health failed to react to the revolt, ward nurses took to protesting against their working conditions. Patients were transferred for a second time.

“It’s very difficult because you’ve got the constant pressure to admit sick people,” said the former staff member. “These are ordinary dormitories, with no barrier [between patients and staff]. Eventually after 16 June they put a security gate which a patient broke not long after. There is no barrier, so you sit in your office and the patients break through. I feel sorry for the nursing staff because they work under very difficult conditions.”

The source told Spotlight that as a result of the dangerous conditions, the unit faces challenges when admitting children and young adults for fear of their safety.

According to the whistleblower, the risk is high for abuse.

“We know that sexual abuse in wards is rife. The big thing is we have to put all the different pathologies and age groups in one ward. There is not even a single room to separate them. So if you’ve got an adolescent that’s small in stature and you’re worried about abuse, where do you put them?”

On top of safety concerns, the former staff member says that security staff members were poorly trained, recalling that frequently weapons from patients were missed by security, photos of which were published by Grocott’s Mail last year.

Not enough staff, not enough rehabilitation

Documents shared with Spotlight outline the dire staff shortages at the unit, including the lack of a psychiatrist.

“There has been no psychiatrist since December 2018,” said the former staff member. “They can’t get anyone there because our name is so bad. No one wants to come here, to Cecilia. We’ve got good staff but you can’t work under these conditions for the long term.”

Along with critical staff shortages, dismal infrastructure and a lack of safety and security; there are no recreational facilities for patients. There’s only an empty cement courtyard.

“There’s very little rehabilitation going on. It’s basically pharmacotherapy. That’s the reality, there’s nothing else to do,” said the former staff member.

The future of the unit?

Despite commissioning a new psychiatric facility for Cecilia Makiwane in 2012, the Department of Health has failed to deliver on its promises.

Kupelo said that following the fire “we agreed to conduct, using a specialist to assess the structural, safety, and design, a suitable service platform to accommodate the patient move to the new refurbished facility”.

Spotlight sent follow-up questions asking for clarification on the new facility but did not receive a response.

The documents seen by Spotlight suggest that the department has no money to complete the scheduled renovations of the hospital, and that a new facility would not be plausible for another five years.

The department’s 2017/18 budget shows that R695-million was set aside for the eight psychiatric hospitals and units in the Eastern Cape, including the CMH Mental Health Unit. This was R100-million more than the 2016/17 allocation of R596-million. However, during the 2017/18 financial year the initial budget was cut by R195-million (roughly 28%) to result in a final adjusted budget of R500-million, which was R96-million less than the 2016/17 budget that had been fully spent. 

The Ombud investigates Tower, leaves CMH to the wayside

On 27 March 2018 Spotlight understands a formal complaint was laid with the Office of Health Standards Compliance (OHSC) for the Ombudsman to investigate the Mental Health Unit’s various issues. The complaint contained harrowing information about the unit dating back to 2007. Although the OHSC acknowledged receipt of the complaint on 6 April, it appears that no investigation took place.

OHSC spokesperson Ricardo Mahlakanya could not confirm to Spotlight that there was an individual investigation into the unit. “In the report on Tower Hospital (another hospital in the Eastern Cape) we made the recommendation that a mental health administrator be appointed to look after all mental health services in the province,” he said.

In the 2018 report on Tower Hospital, Cecilia Makiwane is mentioned only once and that’s in reference to a Tower Hospital patient who was recovering from burn wounds. The report does not address CMH’s Mental Health Unit.

Health Ombudsman Malegapuru Makgoba hauled the Tower Hospital whistleblower over the coals in August last year. This, according to some activists, has set a dangerous precedent for the future of whistleblowing in South Africa’s medical field.

This attitude towards whistleblowing has sounded alarm bells for the watchdog group, the Public Service Accountability Monitor (PSAM).

“This is cause for concern that we raised with the Tower Hospital exposé,” said PSAM director Jay Kruuse. “When people finally go public, there is backlash directed at them and at [staff] who have been working in intolerable conditions.”

Kruuse said the documents that Spotlight has acquired reveals significant levels of patient violation at Cecilia Makiwane and he described the revelations as “damning”.

“One would have thought that amidst the critical findings from the Tower Hospital investigation and the acknowledgement by the health minister, corrective action would have followed. The material suggests strongly otherwise,” he said.

“We have come from the Life Esidimeni deaths that occurred following the transfer of patients to NGOs, to the human rights violations at Tower Hospital rightly exposed by staff and interested and affected parties. All of these cases show that those who have mental health conditions and who are extremely dependent on the state for their day-to-day care are treated less humanely.”

Kruuse emphasised that whistleblowers and staff should not be victimised for speaking out, considering that they, as well as patients, have already been victims to the current conditions.

*The South African Society of Psychiatrists declined to comment on the investigation at this time.

**Budget information provided by PSAM

Kathryn Cleary is a health journalist with Grocott’s Mail in Makhanda, Eastern Cape, and was commissioned by Spotlight to write this article.