With effect from June 1 2017, the Medicines and Related Substances Amendment Act, No 72 of 2008, came into force by proclamation by the President of the Republic of South Africa.

The coming into force of the Amendment Act is significant insofar as it shifts and fundamentally changes the medicines regulatory regime in South Africa, and alters the Medicines and Related Substances Act, No 101 of 1965, as amended (the Medicines Act).

The Amendment Act of 2008 must be read together with a further Amendment Act, being the Medicines and Related Substances Amendment Act, No 14 of 2015. Both Amendment Acts come into force simultaneously and give effect to numerous amendments to the Me-dicines Act.

In addition to amendments to the Medicines Act, the amendments attempt to reconcile an arguably uncomfortable relationship between the Medicines Act, prior to its amendment, and the contents of various general regulations promulgated under the Medicines Act, which deal with such matters as complementary medicines and the registration and licensing of medical devices.

The most fundamental change brought about by the Amendment Acts is the change in the regulatory authority in charge of the regulatory oversight over medicines, medical devices, complementary medicines, foodstuffs, cosmetics, in vitro diagnostic medical devices and related substances, from the Medicines Control Council to the South African Health Products Regulatory Authority, or SAHPRA.

SAHPRA is an organ of state, but is outside of the public service. In terms of the now-amended Medicines Act, SAHPRA is a juristic person and subject to the provisions of the Public Finance Management Act, No 1 of 1999, but reports to the Minister of Health. The Registrar of Medicines now becomes the Chief Executive Officer of SAHPRA.

Powers vested in SAHPRA include those to register products as one or more of a medicine, medical device, complementary medicine, foodstuff, cosmetic or in vitro diagnostic medical device. To this end, amendments have been effected to section 14 of the Medicines Act, which require that only registered products are allowed to be sold in South Africa.

Accordingly, the manner in which the reimbursement for the costs of such products takes place will be affected in terms of, for example, the Medical Schemes Act, No 131 of 1998, as amended, insofar as medical schemes may only reimburse the costs of registered products.

In respect of products currently available in the South African marketplace but are not registered, the provisions of amended section 14(3) allow for such products to continue to be sold in the South African marketplace, but application for the registration of such products must be made within six months of the date of declaration published by SAHPRA requiring registration.

In terms of Amendment Act No 14 of 2015, certain fundamental definitions change in respect of both how one identifies a particular substance as a medicine or medical device, respectively. Therefore, the amended definitions become important in order to determine what substances must be registered in terms of the Medicines Act and are subject to the regulatory restrictions now imposed by the Medicines Act, as amended.

The definition of “medicine” has been amended to read as follows:

“(a) Means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in –

i. The diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or

ii. Restoring, correcting or modifying any somatic or psychic or organic function in humans; and

(b) Includes any veterinary medicine.”

The term “medical device” has been modified and lengthened, and now provides as follows:

“Means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and IV Hazardous Substances contemplated in the Hazardous Substances Act, 1973 (Act No 15 of 1973)

(a) Intended by the manufacturer to be used, alone or in combination, for humans or animals, for one more of the following –

i. Diagnosis, prevention, monitoring, treatment or alleviation of disease;

ii. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

iii. Investigation, replacement, modification or support of the anatomy or of a physiological process;

iv. Supporting or sustaining life;

v. Control of conception;

vi. Disinfection of medical devices; or

vii. Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and

(b) Which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in human or animal body, but which may be assisted in its intended function by such means.”

Another important impact of the Amendment Acts on the supply of medicines and medical devices is the coming into effect of amended section 18A of the Medicines Act. Amended section 18A prohibits the supply, which arguably includes the sale, of medicines, medical devices or in vitro diagnostic medical devices in terms of a bonus system, rebate system or any other incentive scheme.

Although there are transitional provisions applicable to the regis-tration of medical devices currently available in the South African marketplace, no such transitional process or provision has been made for the application of section 18A. However, arguably, section 18A applies only to registered medicines and medical devices, as the case may be.

Notwithstanding the arguments available to suppliers of medical devices, where such medical devices are available for sale in South Africa but not yet registered, a cautious approach should be taken to the manner in which such medical devices are supplied with reference to the particular regulatory regime now applicable to such objects under the amended Medicines Act.

Under Amendment Act No 14 of 2015, the various functions of
SAHPRA are set out in section 2B. SAHPRA is empowered to deal comprehensively with the medicines and medical devices market-place in South Africa. SAHPRA is charged with the process of registering such products for sale in the healthcare market in South Africa.

In addition to the functions of evaluating applications for registration, SAHPRA is empowered to liaise with other medicines and medical device regulatory authorities or institutions in order to obtain information and exchange information with such institutions in respect of “matters of common interest” or “a specific investigation”, and enter into agreements with such institutions in order to further the objects of the amended Medicines Act.

One of the more novel functions awarded to SAHPRA, in terms of section 2B(1)(c), is to “ensure the periodic re-evaluation or re-assessment and monitoring of medicines, medical devices and IVDs”. Therefore, simply because one achieves registration of a medical device
or medicine does not mean that
the registration is inviolable, and
SAHPRA reserves the right to re-evaluate the registration of that medicine or medical device should, presumably, particular circumstances arise.

One further consumer-driven aspect of the Medicines Act, as amended, is the introduction of the term “vigilance”, which is arguably closely related to the provision of the Consumer Protection Act, No 68 of 2008. The term “vigilance” is defined in the Medicines Act as, in relation to a medicine, medical device or IVD, “the continuous monitoring and evaluation of its safety, efficacy and performance profile and the management of any risk throughout its life-cycle”.

The Amendment Acts introduce vast and far reaching amendments to the Medicines Act, and change, as stated, fundamentally the regulatory regime applicable to such items as medical devices, complementary medicines and health supplements. Whether or not the amendments promise a more effective regulatory regime remains to be seen.

Manufacturers, importers, distributors and retailers are advised to familiarise themselves with the regulatory regime under the am-ended Medicines Act in order properly to understand their rights and obligations, both to SAHPRA and
to stakeholders, including consumers, in the South African healthcare sector.

Omnicell, Inc. announced that its robotic dispensing solutions company, MACH4 Automatisierungstechnik GmbH, has been recognized by the German Healthcare Partnership, the Federation of German Industries, and the Biotechnology Industry Organization of Germany for its efforts in innovation to provide better access to pharmacy services in South Africa. The Federal Minister of Economics and Energy, Brigitte Zypries, presented the Company with the German Global Health award at the Allianz Forum, Pariser Platz in Berlin, on May 17.

MACH4 Automatisierungstechnik GmbH was recognized for its Pharmacy of the Future project. Pharmacy of the Future places robotic dispensing systems, with Patient Dispensing Units (PDUs), in shopping centers to improve access to medicines in South Africa. The program was developed in partnership with Right to Care, Right ePharmacy, the Department of Health South Africa, The Deutsche Gesellschaft für International Zusammenarbeit GmbH and USAID. Goals of the project are easier accessibility and decreased waiting times in outpatient pharmacies for patients with stable but chronic conditions. Patients without access to these systems have to travel to clinics and hospitals every month to refill their prescriptions, even if they are stable and do not require medical consultation. Waiting times for these patients can average four to five hours.

The collaboration seeks to provide better access and adherence to medications for the estimated 7.5 million South Africans infected with human immunodeficiency virus (HIV). The partnership began as a pilot project that will be handed to the national health system to ensure sustainability and structural adaptability going forward.

“We’re honored to be recognized with the German Global Health award,” said Dirk Beils, senior director, Engineering at MACH4 Automatisierungstechnik GmbH. “Just as we’re inspired by the care providers deliver in the acute setting, we’re also committed to creating a better life for those who are actively advocating for their own health. We hope the implementation of these PDUs will forge a pathway toward a healthier population that will continue to serve the country of South Africa for years to come.”

Healthcare could be an engine for growth in the economy, according to Cimas chief executive Vulindlela Ndlovu. He told journalists there was the potential for specialist health institutions to be established that could attract patients from other countries.

He said there was a critical shortage of specialists in Zimbabwe in certain areas, necessitating treatment for some conditions in other countries.

Yet there were areas of specialist expertise where, if local specialists came together to establish affordable specialist health institutions, not only could Zimbabweans be treated locally but patients could be attracted from other countries.
Addressing journalists at a recent ZimSelector Journalists Insurance Mentorship Programme workshop, he gave an eye hospital as an example of a specialist institution that local eye specialists could establish.

At present Zimbabweans and people from all over Africa were being referred to an eye hospital in South Africa for treatment. If eye specialists in Zimbabwe were to establish an eye hospital, they could attract patients from other countries who currently had to go to South Africa, he said.

Mr Ndlovu said medical aid societies were playing a critical role in the health sector both in funding medical treatment and in providing health and medical services themselves.

He denied there was any conflict of interest in medical aid societies establishing health service facilities. Doing so worked well in other countries. Medical aid societies established these facilities because they wanted to ensure as many people as possible had access to health facilities.

Challenges medical aid societies faced included the lack of a common economic tariff agreed to by both funders and service providers, delays in contribution payments, fraud and the costly disintegrated medical practice units, which resulted in high costs, as each service provider charged separately for the services provided for a medical procedure.

An operation at a private clinic could results in six different invoices, after the hospital, surgeon, anaesthetist, laboratory pathology and others, such as a physiotherapist, had submitted their bills.

In India, he said, included in a hospital package were the services of a whole suite of specialists.

He cited the example of a child with a chronic mental disorder treated in India. At the hospital, the child was seen by a neuro-paediatrician, child development specialist, psychiatrist, ophthalmologist, ear nose and throat specialist, speech therapist, occupational therapist and physiotherapist, all for the same price as it would have cost just for the services of a single neuro-surgeon in Zimbabwe.

He said Cimas was placing a major emphasis on promoting wellness among its members. Instances of non-communicable diseases such as hypertension, diabetes, heart disease and cancer were all on the rise.

Wellness programmes, which included exercise, the correct diet and lifestyle changes such as giving up smoking and reducing one’s alcohol intake, reduced the risk of these diseases. Hence the importance Cimas was according its wellness programme to improve the quality of life of its members and help extend their lifespan.

Cement maker Bamburi has offered its retailers a Ksh150 million ($1.5 million) medical insurance cover.

The Afya Ya Nguvu deal for inpatient and outpatient cover, whose underwriters are Sanlam General Insurance, is expected to benefit 800 people to reward the retailers’ loyalty.

The scheme will be administered by Alexander Forbes.

“We conducted a market survey and realised that only 36 per cent of our retailers had medical insurance. Afya ya Nguvu is a direct response to this need,” said Bamburi managing director Bruno Pescheux.

Alexander Forbes executive director, James Olubayi urged companies to develop solutions to ease the burden of health costs on their various constituencies, which are critical for the survival of any organisation.

“When innovation in product design is applied then one can strike a balance between benefits and price,” he said.

Healthcare in Kenya remains a costly affair as most families rely on savings to access health care and are often pushed to fundraise to manage chronic illnesses.

The cement maker is the first manufacturer to offer such a service to its retailers in Kenya, where a majority of health insurance schemes are offered to employees in the formal sector.

As at January 2017, 6.2 million Kenyans were registered with the National Hospital Insurance Fund, but only four million were consistent with their monthly payments.

Informal sector workers make up only 39 per cent of the total workers registered with the NHIF, despite constituting 83 per cent of the over 15 million Kenyan workforce.

Kenya has the highest informal sector employment in Africa, accounting for 77.9 per cent of total employment, ahead of Rwanda’s 73.4 per cent Uganda’s 59.2 per cent and Tanzania’s 8.5 per cent according to a 2015 report by United Nations’ Economic Commission for Africa.

Medical insurance accounts for only 22.1 per cent of the Kenyan insurance market. A survey by online health service provider Daktari Africa shows that only 12 per cent of Kenyans are subscribed to insurance programs, translating to 480,000 people out of the country’s over 40 million population.

Rwanda has achieved some of the most dramatic gains in health and poverty-reduction in the world. This small, landlocked African country (the size of Massachusetts, but with twice the population) has developed a primary health-care system with near-universal access to clinical care and insurance. Rwanda has reduced both economic and health-care inequality, and demonstrates how “health equity” helps to build strong societies.

The secret to Rwanda’s success is that its leaders are building “modern institutions on traditional values.” They built a system of community justice, called Gacaca, which integrated their need for nationwide reconciliation with an ancient tradition of clemency. They breathed life back into a civic tradition of Umuganda, where one day a month, citizens, including the president, gather together to weed their fields, clean their streets, and build homes for the poorest among them.

In 2015, the government of Rwanda and the Boston-based Partners In Health (PIH), with the help of the Bill & Melinda Gates Foundation and the Cummings Foundation, established the private, not-for-profit University of Global Health Equity (UGHE). The university is founded on the principle that every member of a community deserves the same care and opportunity, and focuses on the delivery of quality health care to those who need it most. Agnes Binagwaho, a co-founder of UGHE who is a former minister of health and an adjunct professor at Harvard Medical School, once said to me, “Why would I want to raise my children in a nation where all children don’t get the same medical care as they do?”

Rwanda’s government has already pledged $43 million to UGHE in land and infrastructure support. Its leaders have launched a two-year, part-time Master of Science in Global Health Delivery to teach how to create national health care in developing countries. Lecturers from Rwanda’s Ministry of Health, Harvard Medical School, Yale University, and Tufts University taught Rwandan students everything from epidemiology to budget management.

Last summer, UGHE began construction on a 250-acre campus in Butaro. This year, 250 professionals from as far away as Mexico and Australia will compete for 25 spots on that campus. Undergraduate and graduate degrees in nursing and oral health, and non-clinical programs in research and health management, are next. In 2018, UGHE’s campus will also be home to a school of medicine. It will provide space for generations of health professionals to learn how to heal patients, comprehend the sociology of disease, and build the health systems that make a strong society.

UGHE’s founders believe that, by the time the university celebrates its ten-year anniversary, 480 students will have graduated; another 870 will be earning their degrees; and over 2,500 professionals will have attended executive education courses. They expect that over 1,000 of the students passing through the UGHE’s doors in that first decade will arrive from the rest of Africa, Asia, Europe, and the Americas.

Rwandans will invite these international students to visit their communities to observe their traditions and learn how to care for their people. The young men and women will attend Rwandans’ weddings and funerals, learn to prepare and enjoy their foods, and acquire some of their language, the portal through which to view their sturdy values. Rwandans will teach their international guests that in Africa, family is an all-encompassing concept, and that, in Rwanda, an entire generation treats the next as its own children. The international network of UGHE alumni, unified by their commitment to realize health equity for their own communities, will become a global force for change.

UGHE will also strengthen Rwandan society. Though regarded by many as one of the safest and least corrupt societies in the world, Rwanda faces a great shortage of doctors and nurses. There are 684 physicians in Rwanda, a total that is far below the 1,182 physicians proposed by the Ministry of Health, and only 27% of the World Health Organization’s recommended minimum of 2,576 physicians.

UGHE has already generated jobs, by hiring local laborers, and has increased access to the region, by creating new roads. It could boost Rwanda’s GDP by 0.5% per year, and every dollar invested in UGHE could generate $2 worth of return in economic development, according to McKinsey & Company.

Some social scientists assert that poverty is not just a matter of poor nutrition, lack of medical care, and inadequate shelter; it also means exclusion from global networks of trade, science and commerce.

UGHE will be Rwanda’s newest institution, a public-private collaboration based on traditional values: community, trust, hard work, and optimism about the future. It will integrate each citizen of Rwanda into global networks of learning. The Rwandans will accomplish this, as they do many things, because they believe that the only investment that can bring infinite returns is in their children, and because graduates of the University of Global Health Equity will be their sons and daughters, too.

Kenya has become as the first country in the world to launch new child-friendly medicines for treating tuberculosis (TB).

The drugs are strawberry-flavoured and dissolve in water to make it easier for children to swallow.

The number of tablets given to children has also been reduced by half, from eight to four pills daily.

The Ministry of Health said the new drugs, to be rolled out countrywide by October 1, will be given to children depending on the child’s weight

About 7,000 children in the country have TB.

The flavoured regimen, known as a “fixed dose combination”, will be available for free at all health facilities countrywide.

The Kenyan government spends about Sh2 billion annually to treat TB.

Kenya has announced it will donate $5 million (Sh500 million) to the Global Fund to fight Aids, tuberculosis and malaria as other international donors pledged over $12.9 billion for the next three years to help end the epidemics.

Kenya’s pledge at the launch of the Fund’s fifth replenishment made it one of the highest contributors from Africa.

The replenishment conference was hosted in Montreal, Canada, between September 16 and 17 by Prime Minister Justin Trudeau, who said there was a need to engage the youth in order to succeed in global health.

Canada increased its own contribution by 23 per cent to CAD$804 million, with many new partners making first-time pledges.

At the same time, private sector contributions more than doubled.

The Kenyan government donation is part of the concept of “giving to receive” that requires countries that benefit from the global fund to also make contributions.

Last year, Kenya pledged $2 million (Sh200 million).

Running the seventh largest Global Fund portfolio, Kenya is expected to receive more than Sh34 billion from the Global Fund in the next three years.

Other countries from Africa that made contributions to the Fund include South Africa ($5 million) and Namibia ($1.5 million).

“We can end these epidemics for good if we accelerate our efforts and continue to bring in new partners,” said Mr Trudeau.

Global Fund financing comes primarily from the public sector, with approximately 95 per cent of total funding coming from donor governments and the remaining 5 per cent coming from the private sector, private foundations and innovative financing initiatives.

More than 50 donor governments have contributed to the Fund, with a total of more than $30 billion.

As a public-private partnership, the Global Fund organises a resource mobilization programme every three years for private sector and non-government partners to make contributions to the fund, which is used in financing HIV, tuberculosis and malaria programmes across low- and middle-income countries.