Mental health and pill-taking: Getting beyond HIV

By Professor Francois Venter

Recently, I took part in a chat show on Radio 702 to discuss how to disclose one’s HIV status to one’s sex partners. Hosted by Eusebius McKaiser, the show was vibrant, entertaining and challenging – made more so by the other guest, Thula Mkhize. Thula is an HIV-positive, heterosexual man in a discordant relationship (his wife is HIV-negative). Thula speaks openly and passionately about his sex life, and we chatted about the ethics of disclosing on the first or second or third date, among other things.

Dating when HIV-positive can be very tricky. When do you disclose your status to a new sex partner? How do antiretrovirals impact on your sex life? Why do we sometimes take risks that don’t seem rational? Relationships are hard, but can be so much harder when you have a background condition that is sexually transmitted.

The show went well; but I found some of the callers talking about their experience of disclosure surprisingly moving and upsetting. People were calling in, talking about the enormous impact of HIV on their sex lives, and of partners slowly pushing them away due to their status. This was not the violent, ignorant stigma that we easily identify and loudly denounce, but a more subtle, much more personal rejection. It reminded me of a good friend who is HIV-positive, who when she is about to engage in sex with a guy, says he often behaves as if he were doing her a huge favour, despite her being completely non-infectious on treatment. These little and not-so-little indignities can be devastating, and can prick holes in your self-esteem. Getting reliable support after disclosure is far from guaranteed.

A few weeks ago we lost Prudence Mbele, a beloved long-time activist living openly with HIV, who died of TB. Prudence was famous for her ‘pill holidays’ – a big no-no in HIV-land, as it leads to further immune damage. The idea of someone stopping their life-saving tablets – even temporarily – boggles the minds of most health providers. Her death triggered an intense media and Facebook/Twitter reaction, filled both with criticism at her choices as well as empathy, as people shared their own hard stories about taking antiretrovirals. Yet this notion of ‘pill fatigue’ affects lots of people in the HIV field and beyond, and generates a lot of chatter on social media.

Pill fatigue is a difficult concept to swallow, as a health professional. The daily tablet we use for HIV is small and getting smaller, has very few side effects, and is becoming safer all the time. Public health guidelines in South Africa recommend that a huge proportion of our population need tablets for diabetes, hypertension and cholesterol, among other ailments, especially as people get older. Pills are a part of normal life for everyone as they get older – so why should HIV-positive people complain of pill fatigue?

Some of those reasons relate to anxiety and depression and stigma, now strongly linked to delayed presentation for treatment, as well as adherence to their meds. Sadly, mental health issues are more associated with medical hot air than with any content; very few resources are allocated specifically to this area in either the public or the private sector, despite tons of data suggesting they are important. We have some very spirited and smart mental health professionals trying to change this, but there is in inertia in the current health system. This is also coupled with harsh societal views around mental health – depressed people are told to pull themselves together, think positive thoughts, be grateful – which are less than helpful to people experiencing sometimes devastating physical symptoms as a result of mental ill health. The truth is that mental ill health is probably just as stigmatised as HIV.

What does all of this mean, for someone with HIV? There are no magic bullets; but this is the best advice I can offer:

Identify your mental health symptoms

It’s a good idea to pay attention to your mental health, as well as your physical health. The first step is noticing whether you are feeling different – do you have feelings of hopelessness, persistent sadness, a lack of energy to get through your normal routine, or disrupted sleep or eating patterns? If so, and if these persist for more than a couple of weeks, you may be becoming depressed.

Do you have persistent and repetitive thoughts, worrying about your life or other problems? Do you notice physical symptoms such as shortness of breath, churning stomach or nausea, dizziness or rapid heartbeat, fear of new situations or people? If so, and these persist for more than a couple of weeks, you may be experiencing anxiety.

Get support

The best thing you can do is ask for support. It is sometimes very hard to reach out, especially when you may be afraid of people’s reactions. My experience though is that families and friends can be remarkably compassionate; and studies have shown that people who are open about their HIV status tend to get more support, have fewer issues with adherence, and generally appear to be happier. In one study, people with HIV who had good social support mechanisms reported the same quality of life, once they were on successful antiretrovirals, as people without HIV. Disclosing your HIV status can be scary, but it can also keep you healthy. Similarly, if you notice your mental health is wobbling, disclosing this to your friends and family can help keep you healthy.

Of course, this does not hold true for everyone. The world can be brutal and violent, families may use stigmatising diseases to play out internal politics, and not every spouse is going to be supportive. Use common sense, and choose your support network carefully. Equally, this does not mean you need to rush out and disclose to everyone the moment you get your diagnosis – I’ve seen quite a lot of people treating this period as a kind of confessional. Learning you are HIV-positive can be a huge shock; give yourself time to think it through, and decide when and who you want to disclose to.

American sex therapist Dan Savage famously says that disclosure on a date (or in any other situation) tells the other person only a small thing about you; whereas their reaction tells you everything you need to know about them. While it can be a shock to hear from a friend or loved one that they have HIV, or depression, or any other scary condition, there is no excuse for casually offensive opinions or hurtful comments. You do not have to stand for it, and you can be clear in deciding whether to continue a relationship with an individual who is rejecting or judgemental about your physical or mental health.

You can often find support groups through local churches, NGOs and community organisations. These don’t work for everyone, but can be of huge benefit. You might find that sharing your experiences and finding out more about HIV will be empowering, and this will help keep you both physically and mentally well. Also, you could talk about your mood; and if you are feeling low or anxious, it can be enormously helpful just to tell someone about it.

So pay attention to your friendship circle, family and community; and invest time and energy in these relationships.

Speak to your health professional

It is likely that you will receive very little clinical help concerning your mental health. Many health professionals are woefully under-trained around mental health, and you might find yourself brushed off if you try to talk to your doctor, nurse or even counsellor about this. If you feel strong enough, you can ask questions and insist that your health worker answer them; or if they can’t, that they do their own research and come back to you.

You have a right to mental health care, even though the reality is that South Africa is very under-resourced in this field. Your raising it could be helpful in transforming your own health worker’s understanding, too, and could contribute towards changes in broader mental health policy for everyone, over time. Also, challenge people on social media and in public, when they post trite messaging on mental health issues (the most annoying I have seen is a meme saying that people with depression don’t need tablets – just a pair of running shoes and a forest). They will be more careful next time.

Take your medication

Taking tablets every day for ‘conditions’ when you’re healthy is fast becoming a fact of life for everyone, for everything from high blood pressure to diabetes. Getting onto antiretrovirals, developing habits around swallowing tablets and staying on treatment, and finding the easiest system possible for getting your tablets, will move this aspect to ‘habit’ rather than being a constant reminder of the virus. If you acknowledge to yourself that pill fatigue might actually be systems fatigue – weariness around a health system that remains largely inefficient and unfriendly, and wastes so much of your time – this might help you to address your own negative thought patterns about taking your meds, and help you to stick to the regime. If you can, try to find a clinic that has good systems and helpful, competent staff. This will help you stay mentally healthy too.

If you are persistently depressed, it might also be possible to obtain anti-depressant medications on prescription. Primary healthcare clinics have access to anti-depressant drugs, and these can be a valuable addition to other counselling support. If you have the means, shop around for a professional you relate to – one who is sympathetic to mental health issues.

There are many similarities between taking anti-depressants and taking antiretrovirals. You need to take your meds consistently, without interruption, in order to achieve the best results. You may experience some side effects; but these can often be mitigated by changing the dose slightly, or just waiting for your body to get used to them. Many people take anti-depressants for months or years in order to keep their mood stable and enhance their mental health. There is nothing to fear from these drugs.

Get activated

Use activism to get behind organisations advocating for better health services, for both HIV and mental health. In a recent study we did on truck drivers (most of whom were HIV-negative), rates of anxiety and depression were very high; we see similar prevalence among carers, low-income families living in poor housing, and inner-city dwellers. If you can, donate money to help them campaign, and to hire good staff. Become a vocal supporter of better mental health initiatives, wherever they exist. Challenge your health provider to take mental health seriously, and be bold about opening conversations with your friends and family about mental health. The World Health Organisation estimates that one out of every four people suffers mental illness at some point in their lives, so you are not alone.

You might find useful mental health information and support through one of the smartphone apps or personalised telephonic support lines that are becoming increasingly available. These may involve a cost, but there have been enough studies to show that they can be valuable. Watch this space to learn more about which ones are reliably effective.

What should HIV-negative people and healthcare workers be doing? I guess trying to avoid the trite ‘support’ statements – from ‘Well, at least you’re alive’, to the hideous ‘We will all die one day’ – would be a start. I have been at dinners in white, middle-class suburbia where someone is loudly opining about morality and its connection with HIV, not knowing that the couple across from me are my patients. The same holds for mental health issues – think before saying some stupid, stigmatising thing. There needs to be much more community awareness about the importance of unconditional acceptance and support of people on any kind of chronic medication.

If you’re a health professional, the best thing you can do is to educate yourself around mental health – and learn, firstly, how to accurately diagnose someone with depression or anxiety; and secondly, how best to work out a treatment plan. Mental ill health is rarely healed only through drugs, but more usually involves a comprehensive strategy encompassing talking therapies, good lifestyle interventions, removing stress, treating other health conditions, and prescription medications. Compassion, empathy and the ability to ask the patient questions about their unique experience of living in their own body are crucial. The last thing you should be doing is adding to stigma by putting your foot in your mouth. It is not a moral failing to suffer mental ill health, just as it is not a moral failing to be HIV-positive, or have any sexually transmitted infection.

As South Africans, there are many things that grind us down: corrupt politics; lack of jobs; increasing living costs; high rates of violent crime; poverty and poor service delivery; alcohol abuse; and family and relationship break-ups. If you also take into account the reality that too many of us experienced trauma because of the brutalising effects of apartheid, it is no wonder that mental ill health is so prevalent in our society. Sadly, we have been slow to acknowledge this and implement adequate policies to help mitigate mental illness.

Just as with HIV, every single one of us knows another person who is experiencing mental ill health. However, this may be hidden – due to stigma, shame, lack of understanding, and lack of adequate treatment. As a country, we achieved a lot when we started taking HIV seriously: through activism, scientific research, transformed health delivery systems and a lot of hard work at all levels, we managed to turn the epidemic around and make HIV a manageable condition. We can do the same with mental health, if we are motivated to do so.

Professor Francois Venter is a medical doctor who has been involved in HIV patient care, as well as guideline development and studies on new HIV treatments, for many years. He had lots of support from work colleagues and friends in editing this article.

For more information and resources on mental health, go to:

* This article was first published in a special print edition of Spotlight published ahead of the Treatment Action Campaign’s 6th National Congress held in August 2017. A PDF of that print publication can be downloaded here.

Modernising ART

By Dr Michelle Moorhouse

South Africa, like many lower and middle-income countries, follows the World Health Organization (WHO) recommended public health approach, using standardised drug regimens to treat HIV. This along with task shifting from doctors to NIMART (Nurse initiation and management of antiretroviral therapy) trained nurses has enabled more than 3.9 million people living with HIV (PLWH) to access life-saving antiretroviral therapy (ART) since 2003. ART is undeniably one of the biggest successes of modern medicine, along with vaccines and antibiotics

While we have some pretty great treatments already, there is still room for

improvement. Current first-line ART is a big pill to swallow, it has some unpleasant side effects, resulting in poor adherence and virological failure, and resistance develops quite easily; it will not get any cheaper over time. From the more logistical aspect, the high dose of the drugs that make up first-line ART means they use more ingredients meaning they cost more, and is the reason the pill is so big, which in turn means the packaging is big, and takes up more space in the pharmacy. Clearly, we need treatments which are easier to take in terms of size and are cheaper. And if you compare first-line ART in lower middle income countries (LMIC), some of the drugs being used are no longer recommended in better resourced settings.

Current first line ART

So, let’s look a little more closely at our current first-line ART. According to our

ART is undeniably one of the biggest successes of modern medicine, along with vaccines and antibiotics

national guidelines, most people living with HIV (PLWH) will receive a combination of efavirenz (EFV), tenofovir (TDF) and emtricitabine (FTC) or lamivudine (3TC) as first-line ART. FTC/3TC, which are structurally almost identical, really contribute very little in the way of toxicity generally and are usually continued through subsequent lines of therapy so I am not going to say much more about them here, and going to confine my deliberations to EFV and TDF.

What is great about this combination is that millions of PLWH around the world have been treated with it for years so there is a wealth of experience with it – a bit like that comfortable T-shirt we like to sleep in, for us as prescribers, but perhaps not so much for PLWH. The regimen has proven virological efficacy, is generally well tolerated, is simple to take as it is dosed once daily and is co-formulated into a single tablet fixed-dose combination (FDC).

What are the problems with EFV? It comes with some unpleasant side effects (abnormal dreams, nightmares, hallucinations even and other neuropsychiatric type symptoms mainly; occasionally rash); has a very low resistance barrier; and requires a high dose. Its safety in pregnancy has been established despite a bumpy start in early development and it plays relatively well with most other drugs, including TB drugs (but not all, for example some contraceptives such as implantables). EFV is an example of one of the first-line drugs which has disappeared from first-line treatment in many wealthier countries.

Alternatives to EFV

So how do we improve on EFV? There are a number of alternatives to EFV to consider which are currently available in South Africa. Rilpivirine (RPV) is one option, from the same class of ARVs as EFV, and is dosed at 25 mg (compared to 600 mg of EFV which contributes significantly to the size of the FDC). RPV is much better tolerated than EFV and is incredibly cheap, which is always good news in a drug which could be potentially be used to treat millions of people. The downside is that it is not yet available in any FDCs in South Africa, can’t be used with rifampicin-based TB treatment or in anyone with a high viral load when starting treatment, and in the public sector we don’t do viral loads at treatment initiation, so it too has its warts. However, it is being studied in some interesting new combinations so let’s not completely set it aside just yet. Certainly as a switch option RPV is a very good choice in patients who don’t tolerate EFV, and there are studies which support this.

Dolutegravir (DTG) is another option already available in South Africa. Again, another low dose drug at 50 mg. In registrational first-line studies no one with virological failure developed any DTG resistance which means this drug is incredibly robust. DTG was also the first drug to ever beat EFV in a head-to-head study, where pretty much all others had previously tried and failed, and this was probably a lot to do with the fact that DTG is more tolerable than EFV. And as the saying goes, if it sounds too good to be true… In fact, there are emerging data suggesting there may be some side effects which include dizziness and anxiety. But this is coming mainly from European cohorts, which do not have the same genetic diversity of African populations. Currently a massive study called ADVANCE that compares DTG to EFV is underway in South Africa and includes screening for these types of symptoms. DTG is also available already co-formulated in SA with abacavir (ABC) and 3TC, but it is not practical to roll out this particular FDC programmatically as ABC is very expensive.

But as DTG requires only a 50 mg dose, if it were to be introduced into the public sector programme, produced by a generic manufacturer with South Africa’s buying power as the largest consumer of generic ART in the world, DTG would be an affordable option for first-line ART, and is currently an alternative option in the WHO guidelines. With regard to DTG and TB drugs there is an interaction, which can be overcome by adjusting the dosing of the DTG, but this might not be necessary – some studies are underway to look into this. One of the current challenges with DTG is at this stage we don’t know a lot about DTG in pregnant women. Botswana made the bold move of introducing DTG into their HIV treatment programme in June 2016, including for pregnant women and it is anticipated that they will present data on the first pregnancies at the IAS conference in Paris in July 2017 which will start to fill this gap. So, we have a very robust drug that is well tolerated and can be co-formulated into a small inexpensive pill – looks promising.

Then there are also other future third-drug options which are not available in South Africa (or indeed anywhere else) as yet. These include doravirine and bictegravir. Doravirine is from the same class of drugs as EFV and RPV. It is still in phase 3 of development (registrational studies) and whether or not it will ever hit our shores is unknown. Bictegravir, also in phase 3, is a drug which is very similar to DTG and is co-formulated with tenofovir alafenamide fumarate (TAF), which I will discuss a little more below, and FTC.

An alternative to TDF

So, moving on to TDF. The problems with TDF are in some ways similar to those with EFV. The high dose means a high active pharmaceutical ingredient requirement which drives the pill size and the cost. And it also has some toxicity associated with it. Currently, we do not have any alternatives available in South Africa  that are any better but there is one which should be available soon, namely TAF (tenofovir alafenamide fumarate). TAF, like the TDF in current first-line ART is a pro-drug of tenofovir. TAF is given at a much lower dose (approximately 10-fold lower) than TDF. TAF is associated with much less kidney and bone toxicity than TDF. The ADVANCE study will also compare TAF and TDF, as most studies of DTG used ABC as the backbone, and also would not have included many African participants. TAF has not been studied with TB drugs or in pregnant women as yet, but these studies are underway. Once we have a better understanding of this, on account of the better safety profile and the lower dose which will result in significant reductions in cost, TAF is set to be a favourable option to replace TDF.

And in fact, if DTG, FTC and TAF are co-formulated potentially we are looking at a future first-line regimen, to quote Prof Francois Venter, “smaller than an aspirin” which is incredibly potent, incredibly robust, incredibly well tolerated, all while being incredibly cheap – incredible isn’t it?

ART does not exist in a vacuum

All of this is very important, while we have such tough targets to chase – the famous 90-90-90. And to achieve that third 90 we need to modernise treatments so that PLWH can adhere to them. When there are so many other challenges to overcome within a healthcare system, optimising ART to be as simple, safe, efficacious and robust as possible facilitates safer task shifting to other cadres of staff which may help alleviate some of the human resource shortages faced within healthcare facilities.

But no matter how good the drugs are, ART does not exist in a vacuum, and ART alone will not achieve the three 90s. ART will not fix the healthcare system. ART will not address stigma. ART will not help us achieve that first 90 – 90% of PLWH knowing their status. ART will not find the missing in action to test them – the men, the key populations, the adolescents, girls and young women – and then link them to care to achieve the second 90. ART will not then retain them in care, and measure their viral load so we can see if we are reaching that third 90.

Massive investment in infrastructure and development of systems backed by political will is critical. Civil society must remain engaged and all of this must be backed by a National Strategic Plan (NSP) that is realistic, detailed, and embodies the principles of equity and access. There is a massive amount of work to be done to conquer HIV in South Africa, but optimised ART is certainly a great step in the right direction.

Dr Michelle Moorhouse – Wits Reproductive Health and HIV Institute and Southern African HIV Clinicians Society

HIV docs win quack HIV gel case

By Lauren Jankelowitz, CEO SA HIV Clinicians Society

The South Gauteng High Court this week ruled in favour of the SA HIV Clinicians Society in its legal battle with a doctor who promoted a product marketed as Dr Hugh’s Dermo Blue Pre-sex Protection Gel, which claimed to prevent HIV infection.

The Society previously informed clinicians and patients that the gel was untested and not proven to work, and explained the steps it had taken to ensure that the product was withdrawn from the market. This ultimately led to the doctor suing the Society for defamation.

The Society has an evidence-based approach to all its work and this is what was used when we considered the product in question. Part of the work of the Southern African HIV Clinicians Society includes constant efforts to debunk non-proven HIV “cures” and emphasise the importance of offering patients therapies that have been tested according to rigorous standards.

We are relieved and satisfied with the outcome. Part of the Society’s mandate is to provide doctors with the evidence that they need to give patients the best possible quality of care. Part of safeguarding patients is preventing the sale and use of untested products.

Such products, whether they are marketed as HIV cures or ways of preventing HIV infection, could encourage people to feel safe under false pretenses and thus put them at risk, and even cause harmful side effects. The Society reiterates the importance of taking HIV medication or using HIV prevention methods that have been thoroughly evaluated according to the highest scientific standards. This is the only way to ensure that those who seek medical care are protected.

“People who feel that they are at risk or fear for their health can be very vulnerable and thus fall prey to those selling quick-fixes or untested remedies. The Society plays a crucial role in ensuring that these patients aren’t taken advantage of and receive the best care possible,” says Society board member Professor Yunus Moosa.

Society President Dr Francesca Conradie agrees: “The Society aims to advance evidence-based interventions, whether for prevention or treatment. We will continue to work as advocates for those affected by HIV. This ruling is fantastic news for us.”

 

Fly by night tenders: A Spotlight special investigation into aeromedical service in South Africa

By Marcus Low and Ntsiki Mpulo

Aircraft have been used effectively to provide emergency medical services and to transport medical specialists and other supports services to deep rural and underserved areas in South Africa since 1960. However, an investigation has revealed that the provision of such aeromedical services has become mired in questionable tenders. Now, a relatively unknown Free State emergency medical services company, new to aeromedical services, is rapidly winning government contracts in the so-called Premier League provinces and two others.

The tender for aeromedical services in South Africa is called RT-79. It is run by the National Treasury – and not the Department of Health, although the latter does play an important role. RT-79 has been advertised and awarded three times – in 2009, 2012 and 2015.

However, the 2015 RT-79 tender was cancelled at short notice in mid-2016 without a new tender to replace it. This created a vacuum in a number of provinces that was soon filled by a newcomer to aeromedical services – a company called Buthelezi EMS, owned by Thapelo Buthelezi.

Spotlight previously reported on Buthelezi EMS allegedly providing sub-standard ground ambulance services to the Free State Department of Health. The Democratic Alliance has also questioned the Free State government’s decision to outsource ambulance services to a private company providing poor service. Attempts to get comment from Buthelezi has been unsuccessful. Their website is still under construction, their Facebook page not regularly updated and some numbers listed on their Facebook page are were not working at the time of writing this article. An e-mail with questions sent to an address an unidentified woman who answered one of the phone lines supplied, went unanswered.

For years, Buthelezi EMS provided only ground ambulance services in the Free State. However, in 2015 they started providing aeromedical services in the Free State.
When the 2015 national RT-79 tender was cancelled, Buthelezi EMS entered into a joint venture with a company called Halo Aviation. Halo previously worked with ER24 and has a proven track record providing aeromedical services. Together, Buthelezi and Halo soon were awarded contracts in Mpumalanga and Limpopo in the following months. They also won a tender in the North West Province. Farhaad Haffejee of a competitor, the non-profit Red Cross Air Mercy Service (AMS) says they were not aware of the North West tender until after it was awarded. Buthelezi EMS also provide services in Gauteng.

However, the process by which Buthelezi EMS has come to be awarded these contracts is currently being challenged in the North Gauteng High Court by AMS. While the cancelation of the RT79-2015 contract meant new business for Buthelezi and Halo, it also meant that AMS were suddenly out of business in Limpopo and Mpumalanga in spite of providing an undisputed quality of service.
According to Haffejee AMS had to retrench staff in both Limpopo and Mpumalanga. “In addition,” he says, “the AMS has taken significant losses because aircraft, hangars, offices, etc that were acquired for the three year duration of RT79-2015 are now supernumerary in the AMS system. As such, the AMS has had to put aircraft on the market for sale and have had to deal with the closure of two bases in Mpumalanga and Limpopo.”

AMS has argued in ongoing court proceedings that proper procedure were not followed when new service providers were appointed in the wake of the cancelation of RT-79. They claim that they were not invited to or asked to bid for the new contracts in Mpumalanga and Limpopo.
“Perhaps what is worrying about all of this is that when the tender was cancelled, National Treasury advised the Provinces not to do business with the AMS,” says Haffejee. “What happened was that both the Mpumalanga and Limpopo provinces were advised to piggyback on a tender (as allowed for by the Public Finance Management Act) of the Free State Department of Health which had been awarded to Buthelezi EMS and Halo. Even though the AMS was already operating in the provinces, providing a service without any operational issues and at a lower cost, the AMS was not considered to continue, even on a month to month basis until such time that all the legal issues had been settled.”

“Further to this, the Mpumalanga Provincial Department of Health went against the written advice of the Mpumalanga Provincial Treasury which instructed them that they were only able to grant Buthelezi a contract for 6 months as per the PFMA and instead gave Buthelezi a tender for a period of 3 years,” says Haffejee. “What is even more surprising is that the rates charged by Buthelezi EMS for this new contract is significantly more than what the AMS was charging under the RT79-2015 contract.”

Spotlight asked National Treasury about the alleged failure to include AMS in bidding processes in these provinces. Treasury did not provide a direct answer to this question. Treasury also claimed that there was nothing wrong with the Mpumalanga tender as alleged.
Treasury did however explain that they provided interim guidance to provinces stating as follows:
“The departments are hereby authorised to acquire the above services in accordance with the following prescripts:

Paragraph 4.7.5.1 of the Guide to Accounting Officer which stipulates that “In urgent and emergency cases, an institution may dispense with the invitation of bids and may obtain the required goods, works or services by means of quotations by preferably making use of the database of prospective suppliers, or otherwise in any manner to the best interest of the State”

Paragraph 16.A6.4 of the Treasury Regulation stipulates that “ if in a specific case it is impractical to invite competitive bids, the accounting officer or accounting authority may procure the required goods or services by other means, provided that the reasons for deviating from inviting competitive bids must be recorded and approved by the accounting officer or accounting authority.”

The reasons for the urgency/emergency and for dispensing of competitive bids, should be clearly recorded and approved by the accounting officer/authority or his/her delegate.”
Commenting on this issue, Ryan Horsman of Halo told Spotlight that “all participating provinces were advised by National Treasury to deal directly with approved service providers to ensure continuation of the provision of an aero medical service within each respective province.” According to Horsman the majority of the provinces preferred this approach “as the general consensus was that the National Tender did not address the unique individual challenges each Province experienced”.

We also put the following question to Treasury: “When the 2015 RT-79 tender was cancelled in mid- 2016, why were well-functioning services that were already in place (such as those provided by AMS) not allowed to continue until such time as a new tender could be concluded?”
The rather puzzling response from treasury was simply that “The tender award prejudiced suppliers that should have been in contention for award of business on the contract.”
It appears services to patients were impacted by the abrupt cancelation of the tender. According to Haffejee Provinces went without an aeromedical service for some time before Buthelezi EMS and Halo was able to set up operations in these Provinces.

Follow up questions we sent to treasury were not answered. Attempts to get comment from the Free State, Limpopo, Mpumalanga and national departments of health were also unsuccessful.

 Why was the 2015 RT-79 tender cancelled in the first place?

Leading up to the award of the 2015 RT-79 tender, AMS wrote to treasury about various concerns regarding the tender specifications. These initial concerns appear to have been ignored by treasury which went ahead with the award of the tender to, amongst others, AMS and a newly formed company called FlyFOFA. AMS doubted FlyFOFA’s ability to deliver and raised its concerns with National treasury. The Kwazulu-Natal Department of Health also doubted FlyFOFA’s ability to deliver and kept AMS under contract – even though FlyFOFA won the tender for fixed-wing services in the province. (We previously reported on the Kwazulu-Natal situation here.) There were additional concerns about the management of FlyFOFA (discussed in the next section), but they appear not to have impacted the cancelation of the tender.

”When RT79-2015 was awarded to Air Mercy Service and FlyFOFA, ER24 as the lead partner approached the Public Protectors office to investigate the award of the tender to these parties as criteria utilised for the award to AMS and FlyFOFA did not match tender requirements,” says Ryan Horsman of Halo. “HALO supported the approach to the Public Protectors Office.”
In line with this complaint, the eventual cancelation of the 2015 RT-79 tender was justified by treasury by the fact that a so-called “utilization factor” had not been disclosed in the tender documents. (A utilization factor is an estimate of how much a service will be utilised and accordingly how much it will cost the state at a quoted rate) Whether it is in fact necessary to disclose utilization factors in tender documents is one of the issues that the court has been asked to consider. AMS argues that non-disclosure of this number in tender documents does not make the tender unlawful and that National Treasury did not follow due process in the cancellation of the tender.

The court battle also involves a dispute regarding the cost implications of the utilization factor that was used. Treasury argues that the number used prejudices the State to about R30million. AMS disputes this and includes in their court papers compelling comparisons indicating that AMS provides the full service required at roughly the same or lower cost than competitors at a higher technical level. In fact, it seems likely from the AMS estimates that the state is getting less value for money by using Buthelezi EMS.

When asked by Spotlight, treasury provided only the following explanation for the cancelation of the 2015 RT-79 tender: “The contract was not in line with the Special Conditions of Contract of the Tender. Evaluation criteria was used that were never part of the evaluation criteria as specified in the tender document. Hence the contract was awarded on an unlawful basis.”
Haffejee is suspicious of the motives behind the cancelation of the tender. “Why was this tender only cancelled nine months after the award?” he asks. “Why did National Treasury never respond to the objections lodged by the AMS immediately after the award of the Fixed Wing portion of the RT79-2015 tender to a non-qualifying operator (FlyFOFA) without any due diligence having been done?”

  A history of questionable tenders

The RT-79 tender was introduced in 2009 at the behest of FIFA, who wanted an aeromedical service meeting certain specifications to be in place in time for the 2010 Soccer World Cup hosted by South Africa. Rhett Davis, Deputy Director for Disaster Management at National Health, was involved with the 2009 tender from the Department of Health’s side. In April 2010, Davis left his job at the department and was appointed Procurement Manager at ER24, a private medical service owned by Mediclinic International (or Mediclinic Southern Africa). Shortly after Davis left the Department of Health, ER24 put in a bid together with a company called Halo and in March 2012 they won the rotor wing (helicopter) tender for the Free State, NorthWest and Mpumalanga. While the movement of individuals from government to companies that subsequently win government contracts is of concern, we stress that we have no evidence of wrong-doing by Mr Davis,  (nor by Mr Theu or Mr Fisha mentioned below).

The Northern Cape tender in 2012 was awarded to a company called Flying Ambulance Pty. The Director of Flying Ambulance Pty was at the time Krause Steyl. Steyl is also director of a company called Aerocare that also provides aeromedical services. According to reports Steyl was involved with Executive Outcomes – a mercenary group that planned a coup in Equatorial Guinea in 2004. The coup failed. Steyl turned state witness and testified against the other conspirators. When asked about the award to Steyl and Flying Ambulance Pty, treasury responded that “National Treasury was not and is not aware of such.”

Prior to Flying Ambulance Pty winning the tender the province had an excellent outreach service which had been developed by the AMS together with the Northern Cape Department of Health over a period of 16 years (started in 1996) which ensured that patients in small outposts received regular visits from top specialists. Not only did it serve the patients it also relieved the pressure on the referral hospitals in the urban centres especially Kimberley. This service saw the eradication of dental and eyecare backlogs in the Northern Cape, infact the NC Province received recognition at the time from National Health for the Province that had made the most significant progress in eradicating backlogs of cataract blindness.

The 2015 RT-79 tender wasn’t any better. As in 2012, people previously involved with the award of tenders won parts of the new tender. A newly formed company called FlyFOFA won the fixed-wing air ambulance and outreach tenders for the Northern Cape and Kwazulu-Natal. The Executive Managing Director at FlyFOFA is Charles Theu – previously the Director of Emergency Medical Services at the National Department of Health where he was the department’s person responsible for RT-79.

In addition, the Chief Operating Officer at FlyFOFA, Thabo Fisha, had in September 2015 been dismissed from a senior position at the South African Civil Aviation Authority (CAA). The CAA told journalist Erika Gibson that the dismissal was not linked to FlyFOFA. The CAA did however state on the record that there were irregularities with the issuance of an air operating certificate to FlyFOFA in January 2015. There are also claims from industry sources that FlyFOFA was issued with an operating license in record time. The CAA told Spotlight that FlyFOFA does not presently have a valid license to provide air ambulance services.

FlyFOFA did not respond to questions sent by Spotlight.
The 2015 tender was unusual for other reasons as well. Originally due to come into effect on 1 April 2015, the award date was delayed multiple times, and with no compelling reason given. The award was eventually made in September. Then, having started late, the tender was abruptly and controversially (as described above) cancelled mere months later in July 2016.

 

Correction and apology

This article was amended on 3 March 2017. According to Mr Rhett Davis his job title at the National Department of Health was “Deputy Director — Disaster Management” and not “Deputy Director of Emergency Medical Services” as originally stated. Additionally, Mr Davis left the Department of Health on 12 April 2010 and not 2011 as originally stated. We also initially wrote that Davis was responsible for “driving” the Department of Health’s involvement with the 2009 RT-79 tender – we have amended this to simply indicate that he was involved with the tender. We also added Mr Davis’s job title at ER24 and a comment stating that we have no evidence of wrong-doing by Mr Davis.
Spotlight did not obtain comment from Mr Davis prior to the initial publication of this article. This was a serious journalistic error. Spotlight apologises to Mr Davis for this error. Spotlight takes sole
responsibility for this error.

The DA’s alternative health plan for South Africa: Yes or No?

By Di Caelers

There’s no arguing that South Africans, especially the poorest of the poor, have a Constitutional right to access healthcare services. Whether it should be free for everyone at the point of care, as is proposed by the government’s National Health Insurance project, is however up for debate in a country grappling with a health system badly in need of some treatment of its own.

The Democratic Alliance says it has the answer, offering in its Our Health Plan for Universal Health Coverage an alternative to the National Health Insurance (NHI), which it says it can deliver in just five to eight years.

In the case of the NHI, the national health department published its latest policy proposals in the Government Gazette on December 10 2015, and the comments and representations on the White Paper continue to roll in. But estimates are that it could take as long as 15 years to implement.

The DA argues for its plan with a stance with which it’s difficult to disagree; that for too many years South Africans’ circumstances of birth have determined access to life-saving healthcare. Everyone will also likely agree the status quo entrenches inequality and skews access to quality healthcare.

But the truth is that rhetoric won’t take the country any closer to actually achieving desperately needed equity in the healthcare arena.

The DA’s plan is well-researched and rich in detail; the common complaint across the board has been that the opposite is true of the NHI, even at this later stage in its road to implementation.

DA health spokesman Dr Wilmot James says his party’s plan is affordable for South Africa, and can be implemented within the existing health budget. There would be no new taxes; to free up resources, he said, they proposed realising an additional R6billion to boost the health budget by bringing the current medical aid tax credit of R17bn on budget. The remainder (R9.43bn) would go towards helping reduce medical aid costs, by subsidising, and so reducing, members’ monthly contributions.

“This would mean that medical contributions would no longer be tax deductible,” James explained.

Predictions for the NHI, on the other hand, are for costs as high as R256bn by 2025, according the White Paper estimates. News reports in July this year also had several commentators warning these estimates were done with an optimistic assumption of 3.5 percent annual economic growth. In addition, while a number of funding options for NHI have been proposed, these lack detail, and many questions about where the money will come from remain unanswered.

James added: “By bringing the medical aid tax credit on budget, and allocating some of it to build better services in the public health sector, those with medical aid are cross-subsidising those without.” He called it an “act of health justice”.

Sounds fine. But going on to hold up the Western Cape as an example of how it’s all going to work out should probably raise some red flags.

It’s true that healthcare in the Western Cape is amongst the best in the country. It’s true that that province boasts a maternal mortality rate which, at 84 deaths per 100 000 live births, is almost half the comparative rate for the country.

But that certainly doesn’t mean everyone in the Western Cape is enjoying equitable healthcare across the board, or that facilities can necessarily withstand scrutiny.

Just last month Business Day revealed data from the Office of Health Standards Compliance, obtained via a Promotion of Access to Information Act (PAIA) application, which pointed to serious problems at public hospitals and clinics, including in the Western Cape.

That paper said just two of the 149 clinics evaluated in the Western Cape, “generally considered to have a well-run health administration”, scored more than 70 percent in the most recent inspection.

Also last month, unions and health professionals in that province warned that a jobs freeze in the health sector meant a crisis was inevitable.

Junior Doctors Association of South Africa chairman Dr Zahid Badroodien said in the Cape Argus: “We foresee a worrying trend developing in which our health system will be void of senior expertise needed to train and mentor doctors in developing their skills in order to best serve patients.”

The DA plan focuses heavily on training, including an extra R1-billion in conditional grants to the Health Education and Training Platform, but staff retention is obviously of paramount importance to ensure there will always be teachers to teach the newcomers.

Admittedly, however, the Western Cape’s health service emerged head and shoulders above other provinces in almost all indicators in the Health Systems Trust’s South African Health Review 2016. So there is clearly plenty that is also being done right.

So what does the DA’s health plan foresee?

James said it essentially ensured a comprehensive package of quality services within the public health system. It would be free at the point of access to everyone, while retaining and reforming the medical aid system.

For those without medical aid, the promise is improved service at clinics and hospitals, better maternal and childcare provision, and free, efficient access at the point of service to emergency services in urban and rural areas.

But that could well be easier said than done, many might argue. Even the DA concedes in its plan that efficient delivery of services in the public sector is compromised, and has been for the past 20 years, and that the primary healthcare system is “simply inadequate”.

Those with medical aid are promised reduced medical aid costs, and access to more efficient ambulance services, free at the point of service.

On the financial front, the plan would provide :

  • An added R1-billion a year to train medical, nursing and health professional staff.
  • An added R2-billion a year for expanded maternal and child health programmes, for which qualifying clinics and hospitals would compete.
  • An added R1-billion for a single number national public-private emergency service governed by an independent board.

James added that medical scheme reform, in terms of the DA plan, would see schemes compete on the cost and quality of health services they cover, rather than on the risk groups they target.

There would no longer be a situation where schemes were disadvantaged by, for example, an over-supply of older, sicker members. So a scheme with only young members would consequently transfer funds to such a disadvantaged scheme, so ensuring each scheme could price its benefits according to the same demographic profile.

Medical aids are big business in South Africa, and whatever plans the DA has for them, they’re unlikely to fall into line without any fuss – especially if they deem the plan doesn’t benefit them.

Although it’ll almost certainly be more palatable that the NHI system, which will, as it stands, allow them to provide only complementary or top-up cover once the project is fully implemented.

Schemes collect R140-billion a year in contributions, even though fewer than 20 percent of South Africans actually have medical cover.

A final obvious red flag is that the proposed system makes no provision for healthcare for the hundreds of thousands of refugees and asylum seekers whose permanent status in South Africa is pending.

The report offers a universal subsidy only to “every South African citizen and legal resident”, irrespective of whether or not they’re covered by the public or private health system.

It’s a concern that’s been argued by human rights activists and advocates for years, but excluding this group from any future health plan for the country is very short-sighted.

What we do know if that free universal healthcare is possible, even in so-called third world countries.

The Cuban health system is recognised worldwide for its excellence and efficiency. Even in the face of extremely limited resources and economic sanctions by the United States, it has guaranteed access for all, and obtained similar health results to those of the most developed nations.

Closer to home, Botswana’s successful health system is dominated by the public health sector, which operates 98 percent of health facilities.

That country’s delivery system is based on the primary health care model, which the DA health plan and the NHI also favour.

Whether the DA will get the chance to implement its plan nationally obviously depends on the voters. But whether South Africans support the NHI ideal, or the alternative offering from the opposition, what’s clear is that the health system as it stands isn’t working as it should, and that an overhaul is absolutely essential.

 

Di Caelers is an experience health journalist and was commissioned by Spotlight to write this article. If you would like to offer a response, please write to [email protected]

 

A new dawn for medicines regulation in South Africa

The Medicines Control Council (MCC) regulates medicines in South Africa. Without the council’s permission, medicines may not be marketed and clinical trials may not be conducted. The MCC plays a critical role in protecting both the broader public and study-participants against the dangers of unproven medicines.

The MCC will soon be replaced by the South African Health Products Authority (SAHPRA). Spotlight asked MCC registrar Dr Joey Gouws and MCC chairperson Professor Helen Rees about changes at South Africa’s medicines regulator.

Spotlight: What still needs to happen before the MCC becomes SAHPRA? And, when is this change expected to happen – is the April 1 2017 date that has been quoted in the media realistic?

Gouws: On 24 December 2015, the State President, signed The Medicines and Related Substances Amendment Act, 2015 (Act 14 of 2015) into law. However, the said Act has not yet been proclaimed by the President as a number of administrative transitional arrangements require implementation prior to the date MCC would cease to exist and SAHPRA be established. The MCC is working towards the 1 April 2017 date for SAHPRA to be established.

Spotlight: By how much have staff levels at the MCC increased in recent years and how much will they increase further once the SAHPRA is fully in place?

Gouws: The staff component at the MCC has been increased by 52 staff over the last 24 months with the view to employ another 30 staff members once SAHPRA is fully in place.

Spotlight: What is being done to ensure new molecular entities (NMEs) are more quickly registered in South Africa? Can you share any evidence that registration times are being reduced? Is the MCC working toward a target time for registering NMEs?

Gouws: Registration timelines for a medicine depends on the submission by the pharmaceutical industry of a quality dossier, with the Regulator having available sufficient resources, with appropriate expertise, to conduct a review of the dossier. Over the last 24 months, additional staff have been appointed at the Regulator and staff have been exposed to various training sessions on regulatory matters. In addition, workshops have been conducted with the industry to explain the requirements for a quality dossier. Registration timelines are still being worked on.

Yes, the MCC is working towards a target time for registration of new molecular entities of 36 months.

Spotlight: Can you share more detail on what is being done to ensure generic medicines are more quickly registered in South Africa? Again, if you can share evidence of reduced registration times it would be appreciated. An idea of a target registration time for generic medicines would also be useful.

Gouws: See the response as per point three, with registration timelines for a generic application of 24 months.

Spotlight: At the moment it is relatively difficult to find information regarding the registration status of medicines in South Africa (certainly compared to the FDA). Are there any plans to make registration information, including assessments of the evidence and reasons for decisions, more readily accessible to the South African public?

Gouws: Medicine is registered by the MCC at each of their six weekly meetings. Following the MCC meeting, the medicines registered are published in the Government Gazette and on the MCC website, www.mccza.com With the view of the MCC transferring to SAHPRA, systems are under investigation to allow for greater transparency in the decision making process of the Regulator. However, the MCC must take into consideration the provisions of Section 34 of the Medicines Act, dealing with confidentiality.

Spotlight: The MCC responded very quickly in relation to ReGenesis in the Free State and other specific cases in recent years. However, quackery and the unlawful marketing of health products remains widespread in South Africa. What is being done to ensure that the MCC has sufficient capacity to clamp down on unlawful marketing of health products, including complementary and alternative medicines and supplements?

Gouws: Complementary medicines have been called up in 2014, with certain pharmacological categories of medicines making therapeutic claims to treat a disease asked/instructed to submit applications to the MCC for registration over a period until 2019, based on disease risk.

In addition, the  maximum levels of certain vitamins and minerals allowed in complementary medicines without requiring the product to be submitted to Council as a high-risk product, have been published. These products require the submission of a so-called orthodox application, which requires safety, clinical, efficacy and quality data before they can be sold.

Finally, legislation requiring the label of the product to include a disclaimer that the MCC has not evaluated the medicine for safety, quality and efficacy, has been implemented since 2014. By the implementation of these measures, the public can make an informed decision on the use of these medicines.

In July 2016, proposed legislation has been published to address the definition of health supplements, which will allow MCC to have regulatory oversight over this category of medicines, once enacted.

The marketing and sale of unregistered medicine is an illegal activity, which is a matter for the police and the courts and not that of the MCC. The Council’s mandate is the evaluation of a dossier submitted, and the registration of the said medicine, if the information evaluated supports safety, quality and efficacy of the medicine under review.

Spotlight: Some commentators and advocates are alarmed by what they see as a lowering of regulatory standards through initiatives like the 21st Century Cures Act in the United States and the Adaptive Pathways pilots in the EU. Can you reassure the South African public that regulatory standards will remain robust in South Africa?

Gouws: Measures such as the 21st Century Cures Act and Adaptive licensing are means to allow, in a limited way, access to specific medicines in a controlled matter, without lowering standards but to increase pharmacovigilance monitoring within the space of ethics versus science.

The regulatory standards in South Africa have been robust, thorough and in line with international best practices. In addition, regulatory standards and requirements are published on the MCC website for scrutiny and comment by all stakeholders prior to implementation.

Spotlight: To what extent and in what ways is the MCC sharing information and cooperating with other regulatory agencies such as the FDA and EMA?

Gouws: The MCC is a member of various international medicines initiatives that include the FDA and EMA. This includes but is not limited to:

  • PIC/S – Pharmaceutical Inspection Co-operation Scheme: allows the exchange of medicine manufacturing site inspection reports amongst/between regulators to allow/facilitate work-sharing and to harmonise technical guidelines on inspections.
  • ICMRA – International Coalition of Medicines Regulatory Authorities: supports training activities, regulatory cooperation, sharing of regulatory information and concerted strategic leadership.
  • IGDRP – International Generic Drug Regulator’s Programme: supports work-sharing on active substances, mutual reliance in assessment of active ingredients and application of biowaivers.
  • WHO – World Health Organisation: supports medical devices and medicines with respect to quality assurance, safety, medicine access and rational use.
  • EDQM – European Directorate for the Quality of Medicines and HealthCare: supports certification of suitability of active ingredients to the monographs of the European Pharmacopoiea (MCC observer status).

In addition, the MCC has signed a Memorandum of Understanding with the FDA and SwissMedic (Switzerland) to allow exchange of information.

We are keen to increase the transparency of the work of the MCC including giving more feedback to applicants about decisions made, more opportunities for pre-application discussions with applicants for issues that are unusual and/or of critical public health interest, and more transparency to the broader community about the workings and decisions of Council.’ – Professor Helen Rees, MCC chairperson.

Ten patents on two TB drugs

An online tool launched last week sheds light on what patents have been granted for which medicines in a number of developing countries. While the tool is still a work in progress, it is a massive step forward for the transparency of patent status information in South Africa relating to medicines for HIV, tuberculosis (TB) and hepatitis.

The tool called MedsPaL was developed by the Geneva-based Medicines Patent Pool. It can be accessed at www.medspal.org

TB kills 1.8 million people per year and is currently the infectious disease that kills most people on the planet. After 50 years of stagnation, two new TB drugs – bedaquiline and delamanid – have recently been developed. While trials to determine their optimal use are still ongoing, they seem set to revolutionise the way TB is treated, especially drug-resistant forms of TB (DR-TB).

Bedaquiline patents in SA

A search on MedsPaL shows that South Africa has granted five different patents on bedaquiline. The base patent was granted in 2005 and will expire in 2025.

Two so-called ‘new use’ patents were granted in 2006 (for treatment of DR-TB) and 2007 (for treatment of latent TB). South Africa currently grants patents for mere new uses of existing medicines, even though this is not a requirement under international law and these two patents would not have been granted in a number of other countries.

A process patent (2007) and a new formulation patent (2009) were also granted – the latter expiring in 2029, four years after the base patent. New formulation patents are mere reformulations of existing drugs and contains no new active pharmaceutical ingredient. Argentina, for example, does not grant such new formulation patents. India only grants them when they provide a therapeutic benefit.

Delamanid patents in SA

MedsPaL also finds five patents on delamanid in South Africa. We see a similar pattern as with bedaquiline. A base patent was granted in 2005. The base patent was followed by a new use patent (for the treatment of TB) in 2006. There then follows what appears to be two new formulation patents – delamanid in combination with other TB drugs (2008) and delamanid compositions (2007).

As with bedaquiline, South Africa is under no obligation in international law to grant these new use and new formulation patents. Should we wish, we could change our laws to prohibit such secondary patents.

The fifth patent, granted for ‘delamanid intermediate compounds’, only expires in 2032 – more than seven years after the base patent.

Secondary patents like these eight patents on bedaquiline and delamanid often delay generic competition. Due to this lack of competition the prices of medicines in South Africa are often higher than prices for the same medicines in countries with laws that restrict secondary patenting.

Won the battle, lost the war

By Marcus Low & Lotti Rutter

In the early days of the AIDS epidemic, the high price of antiretroviral medicines meant many lives were unnecessarily lost. While the global AIDS movement managed to force lower prices for key ARVs, the wider battle has not yet been won. Today, many people with hepatitis C, various cancers, drug-resistant tuberculosis and other conditions still cannot get the medicines they need to survive. This article explains the how inequality extends to drug development.

There are two broad problems with the way society currently pays for medicines.

The first, the innovation problem, is that we are not investing enough money and energy into finding treatments for diseases mostly affecting poor people. This is why most of our tuberculosis (TB) treatments today are more than fifty years old and not very good.

The second, the price problem, is that many of the medicines that are developed are sold at such high prices that people cannot afford them. This is why many people with hepatitis C cannot afford the highly effective new hepatitis C cures on the market. For these people the new cures might as well not exist.

The innovation problem

Last year, tuberculosis killed more people than any other infectious disease on the planet, including HIV. At 1.5 million deaths, it far outstripped headline-making outbreaks like Ebola (11,315 deaths in 21 months). Yet, in 2014 humanity invested less than US$700 million in TB research – only about a third of the two billion a year that the World Health Organisation estimates is required to bring an end to TB. Of this US$700 million, less than US$100 million was invested by the pharmaceutical industry. In fact, a number of large pharmaceutical companies have stopped doing TB research altogether.

The first part of this problem is simple. Since most people needing TB treatment are poor, pharmaceutical companies see little potential profit in developing new TB treatments. Companies choose rather to invest in researching medicines that will sell in rich countries – medicines for diabetes, heart disease, or erectile dysfunction.

The second part of the problem is more puzzling: given that industry does not invest, one would expect governments to step in to fill the gap. However, with the exception of the United States, governments do not. While the BRICS countries (Brazil, Russia, India, China and South Africa) have over 40% of the global TB burden, they contribute less than 4% of global investment in TB research.

The price problem

When the patent system does deliver important new medicines, as it sometimes does, those medicines are often priced out of reach for many of the people who need it. So, for example, the breakthrough hepatitis C drug sofosbuvir is priced at US$84 000 for an 84-day course. Similarly, high prices mean that women in South Africa who need the breast cancer drug trastuzumab often can’t afford its R500 000 price tag.

Companies argue that they have to ask these high prices to recoup their investment in developing the drugs and to fund their investment in developing new medicines. In recent years this argument has begun to wear very thin.

Companies argue that they have to ask these high prices to recoup their investment in developing the drugs and to fund their investment in developing new medicines
Companies argue that they have to ask these high prices to recoup their investment in developing the drugs and to fund their investment in developing new medicines

A United States senate investigation in 2014 found that the pricing of sofosbuvir had nothing to do with how much it costs to develop the drug. Rather than basing prices on the investments made into a drug, companies are typically setting prices at levels that maximise profits – even if that means many people can’t access the drug in question.

At a more fundamental level, high prices charged by pharmaceutical companies have brought into question the basic social contract between the public and the pharmaceutical industry.

The thinking is that the people, through our governments, grant patent monopolies to companies in return for investment in new medicines. However, enforcement of this social contract is very one-sided. While companies almost always get and maintain their patent monopolies, there is no enforcement of the expectation on companies to invest in research. Typically, companies invest only between 8 and 18% of revenue in research and development (R&D), while they typically spend double on marketing and advertising. In addition, the way in which companies spend their R&D funds is completely non-transparent.

All the available evidence suggests that we are not getting much bang for our buck in the current system where there is no obligation on industry to reciprocate high prices with high investment in R&D.

We have other options

Various solutions to these problems have been under discussion at the World Health Organisation (WHO) over the last decade – with very little progress to show for it. In addition, in 2015 the Secretary General of the United Nations, Ban Ki-moon, convened a High Level Panel to look at exactly these problems. Even if the HLP comes up with strong recommendations, it will be up to governments to make those recommendations a reality.

Some possible solutions include:

An R&D agreement or treaty

Given that industry is failing to invest in diseases that have an impact on poor people, governments have a responsibility to step in and fill that investment gap. One solution is an R&D treaty or agreement. Countries would all contribute to a central fund. Money in this fund would then be used to fund research in neglected areas like TB. This is a simple and workable solution. The only thing that is lacking is political will. Even if rich countries like the United States and Germany oppose such a treaty or agreement, there is nothing preventing other countries from going ahead without them.

Delinkage

When governments invest in research, they often do so in a way that allows companies to patent the products of that research. In this way, governments end up paying twice – once through research grants and again when paying high prices for patented medicines. If governments invest in a delinked way, they will not allow this double-payment to happen. In such a case, governments will fund research through grants and prizes and then ensure that all the research is paid for up front and that the research cost is “delinked” from the sale price of the eventual product. The so-called 3P Project (see our previous issue) is an example of a delinked model.

Bring balance to the system

International law allows for steps to be taken to balance the worst excesses or exploitation of patent monopolies. These balancing measures are commonly referred to as TRIPS flexibilities (Trade-Related Aspects of Intellectual Property Rights) and they include allowances for: compulsory licenses (overriding patents); only granting patents for truly innovative products and not for reformulations or new uses of old drugs; and for the public to file oppositions to the granting of specific patents.

The problem is that due to trade pressure from the United States Trade Representative, many countries have not written these TRIPS flexibilities into their national law – and if they have, they are often afraid to use them.

Doing away with pharmaceutical patents altogether

One of the remarkable things about the history of patents and medicines is that there is no evidence that providing increased patent protection around the world has led to greater medical advances. In fact, in the golden age of medical discovery from the 1940s to 1970s, much of the world did not offer any patent protection on medicines. There was also no increase in innovation following the TRIPS agreement in 1995, which compelled all World Trade Organisation member countries to provide for at least 20 years of patent protection.

It would of course not make sense to simply remove the patent system and not replace it with anything else. The world, after all, is in desperate need of new medicines. Governments would have to redirect the money they would have spent on purchasing patented medicines to providing research grants and sponsoring prize funds for the development of new medicines. All indications are that such a transition would in fact see R&D spending increase dramatically – given how little industry currently spends on R&D as a percentage of revenue.

Lotti Rutter is a Senior Researcher for Treatment Action Campaign

Marcus Low is an editor of Spotlight

 

QUOTES:

You are aware of the exploding prevalence of cancer around the world and in our own country. We have just moved in a circle. Just as the price of ARVs were unaffordable then, cancer drugs are devilishly unaffordable today. If no drastic action is taken today, we are going to be counting body bags like we are at war.”

Dr Aaron Motsoaledi, Health Minister of South Africa, 2016 budget vote speech.
“Rationing is the ultimate consequence of high drug prices. Unsurprisingly, this is unpopular and is causing a backlash. In a number of US states, politicians are seeking to pass legislation forcing drug companies to disclose more information about the cost of producing their high-priced remedies. There is even talk of capping prices. The industry argues that such caps would drive capital out of the industry, cutting innovation and ultimately harming patients. But that is a hard argument to sustain when companies such as Gilead and Vertex are earning gross margins of 90 per cent and share prices are sky high. Pharmaceutical innovation has been one of the great successes of the past century, improving the lives of people immeasurably round the globe. But if the current dispensation is to continue, the industry must learn to price with greater restraint.”

Financial Times, August 16, 2016.

 

The patent system is expensive. A decade-old study reckons that in 2005, without the temporary monopoly patents bestow, America might have saved three-quarters of its $210-billion bill for prescription drugs. The expense would be worth it if patents brought innovation and prosperity. They don’t.”

The Economist, August 8, 2015.