Johns Hopkins grad from Nigeria wants to help hospitals in West Africa go digital

Johns Hopkins grad from Nigeria wants to help hospitals in West Africa go digital

Though paper-based health care is a thing of the past for many hospitals and clinics around the world, in West Africa it’s still the dominant standard.

Adegoke Olubusi wants to change that.

The tech entrepreneur, a recent graduate of the Johns Hopkins Whiting School of Engineering, started OneMedical to help hospitals in West Africa go digital. His team has already begun that process in Nigeria, partnering with more than a dozen hospitals.

Now OneMedical is looking at big opportunity for new funding: the Cisco Global Problem Solver Challenge. The team is one of 15 finalists in the digital innovation challenge, which includes a $10,000 People’s Choice Award open for votes through June 28.

Olubusi, who was born and raised in Nigeria before moving to Maryland for school about a decade ago, has visited his home country often in recent years to work on tech projects like KingsChat, a leading social media platform in Africa.

When his work brought him to hospitals, Olubusi says he found “chaos” in their record-keeping, complicating everything from patient data and billing to inventory. “It’s all on paper—it’s messy, inefficient, and there’s no way to analyze the data,” he says.

But in launching a startup to address these problems, he and his team knew they couldn’t simply transplant U.S. standards into hospitals that had never used electronic records before.

“We thought, ‘How can we make something simple and easy to adopt for hospitals to operate more efficiently?'” says Olubusi, who has also previously worked as an analyst for eBay, PayPal, and Goldman Sachs.

So he and his team—including rising Johns Hopkins junior Sami Ayele—sat down with health care workers in Nigeria to develop prototypes.

“Eventually that turned into an actual idea for a business, and a concept that a lot of people loved,” Olubusi says.

OneMedical offers a user-friendly platform to help hospitals simplify records and streamline processes, with the goal of improving both quality of care and profit margins. It includes a searchable database of patient records, along with features for tracking finances, staff, and medical supplies. The system runs offline at hospitals and syncs to the cloud when there’s an Internet connection available, and it’s accessible through any smart device or operating system.

Hospitals partnering with OneMedical in this early stage are seeing results such as shorter patient wait times and decreased workload for medical staff, the team says. Meanwhile, a waitlist is growing, with more than 25 facilities in Nigeria hoping to get on board.

OneMedical aspires to reach 125 facilities within the next year, ultimately fanning out to other parts of West Africa. The startup is currently part of the Y Combinator accelerator program and last year won Etisalat’s Innovation Award.

Now, with the Cisco Global Problem Solver Challenge, the team is vying for a shot at a $100,000 grand prize, among other possibilities. OneMedical stood out from the more than 1,000 startups applying to land in the finals of the global competition, which seeks digital solutions to tackle economic, social, and environmental challenges.

OneMedical’s entry for Cisco’s $10,000 People’s Choice award includes a video pitch from Olubusi and partner Nick Moore. Votes from the public can be cast online through June 28, and Cisco will announce the winners from all categories on June 29.

Europe, Middle East and Africa orthopedic medical market is expected to grow at a CAGR of 11.2% during forecasted period 2017-2023

Europe, Middle East and Africa orthopedic medical market is expected to grow at a CAGR of 11.2% during forecasted period 2017-2023

Biomaterial is acquiring a huge demand for the treatment of different diseases and condition. They have got a special attention in the orthopedic segment. Many different type of implant are prepare by using biomedical. Increasing aging population is the major driver for the growth of orthopedic market in Europe Middle East and Africa. As this material did not cause any immunological reaction with the body, this makes it as a first choice of preference for manufacturing of the implants. Due to lack of exercise the many different bones and muscle related complication are occurred. This led to increase in the market of orthopedic biomedical in Europe and Middle East and Africa.
Europe, Middle East and Africa orthopedic medical market is expected to grow at a CAGR of 11.2% during forecasted period 2017-2023.

Orthopedic Biomaterials Market is segmented on the basis of, by type of material which is Metals and Non-metals. Metals are further sub segmented into stainless steel, Titanium Alloy, Cobalt alloy and others. Non Metal is sub segmented into Ceramic (Alumina, Calcium Phosphate, Zirconium dioxide. Carbon and Other), Polymeric (Polymethylmethacrylate, Polyethylene, Silicone, Polyester and Other), Natural Biomaterials (Collagen, Chitin & Chitosan and Other) and Others.
On the Basis of application the market is segmented into Joint Replacement, fracture Fixation Devices, Tissue Fixation, Spine implants, Viscosupplementation and Other. Joint replacement is sub segmented into Hip replacement, Knee replacement, Shoulder and elbow replacement and other. Tissue fixation is sub segmented into interference screws, suture anchors and others. Spine implants is further sub segmented into spine fusion, other. Fracture Fixation Devices are sub segmented into Screws, Plates for Bones, Rods and other.

Regional Analysis
Europe and Middle East and Africa are the two major region of the market. Europe has the second largest market for orthopedic biomedical globally. Patient with high level of pain in the bones has no option other than joint replacement which improves the quality of life. Germany and UK are invest ample amount of capital in import of the implants. This can serves as an opportunities for the manufacturer to develop the market in this countries. Due to limited infrastructure development Middle East and Africa has a least orthopedic biomedical market.

The report for Europe, Middle East and Africa Orthopedic Biomaterial Market of Market Research Future comprises of extensive primary research along with the detailed analysis of qualitative as well as quantitative aspects by various industry experts, key opinion leaders to gain the deeper insight of the market and industry performance. The report gives the clear picture of current market scenario which includes historical and projected market size in terms of value and volume, technological advancement, macro economical and governing factors in the market. The report provides details information and strategies of the top key players in the industry. The report also gives a broad study of the different markets segments and regions.

African plant extract could pave way for new drug to treat Alzheimer's disease

African plant extract could pave way for new drug to treat Alzheimer’s disease

A plant extract used for centuries in traditional medicine in Nigeria could form the basis of a new drug to treat Alzheimer’s disease, researchers at The University of Nottingham have found.

Their study, published in the journal Pharmaceutical Biology, has shown that the extract taken from the leaves, stem and roots of Carpolobia lutea, could help to protect chemical messengers in the brain which play a vital role in functions including memory and learning.

The tree extract could pave the way for new drugs to tackle patient symptoms but without the unwanted side-effects associated with some current treatments.

The study was led by Dr Wayne Carter in the University’s Division of Medical Sciences and Graduate Entry Medicine, based at Royal Derby Hospital. He said: “As a population we are living longer, and the number of people with dementia is growing at an alarming rate. Our findings suggest that traditional medicines will provide new chemicals able to temper Alzheimer’s disease progression.”

Neurodegenerative diseases represent a huge health burden globally, placing pressure on health services and having a negative impact on the lives of patients and their families.

Researchers and drug companies are racing to discover new treatments for these disorders and have begun looking to plant extracts as a potential source of novel drugs.

In patients with Alzheimer’s disease and other diseases such as Parkinson’s disease and myasthenia gravis, the activity of the neurotransmitter acetylcholine, is reduced, leading to problems with memory and attention.

Current drugs – called acetylcholinesterase inhibitors – reduce the normal breakdown of acetylcholine. Extensive research is underway to find new versions of these drugs but with additional beneficial properties.

Carpolobia lutea, known more commonly as cattle stick, is a small shrub or tree found native to Central and West Africa. Herbalists in Nigerian tribes use the essence of the root as an aphrodisiac and the treatment of genitourinary infections, gingivitis, and waist pains.

It has also been reported to possess other anti-inflammatory, anti-arthritic, antimicrobial, antimalarial, and analgesic properties. This could be particularly important in Alzheimer’s disease as there is more evidence emerging that Alzheimer’s patients have inflammation in the brain.

The Nottingham study found that the plant was highly effective in preventing the breakdown of acetylcholine but had other beneficial antioxidant properties in fighting free radicals – unstable atoms that can cause damage to cells and contribute to ageing and disease – damage that may be exacerbated in Alzheimer’s disease.

Zim startup shortlisted for Innovation Prize for Africa

Zim startup shortlisted for Innovation Prize for Africa

On Thursday, 15 June, 2017, the African Innovation Foundation (AIF) announced the top 10 nominees who will be competing for the 2017 Innovation Prize For Africa (IAP). Among the shortlisted people was Gift Gana a Zimbabwean who invented a computer aided diagnostic system (Dr CADx) that aims to help the medical industry understand medical images more accurately.

The IPA is a platform that brings together people across Africa to showcase their innovations in healthcare, engineering, energy and communications sectors. This year, people from countries like Democratic Republic of Congo, Egypt, Kenya, Liberia, Morocco, Nigeria, South Africa, Uganda and Zimbabwe stand a chance to win some prizes. The grand prize is US$ 100 000 and the second prize is US$ 25 000. They also have a special prize of US$25 000 for a person who would have created something that has the most social impact. The remaining 7 nominees each receive a voucher of US$5 000. The prizes will be awarded on 18th July 2017 in Accra, Ghana.

Gift’s system aims to solve the problem of patients getting wrong or no treatment because medical images would have been misunderstood. This happens because there are not that many professionally trained people to read medical images (radiologists) on the continent, so most medical images end up being read by general doctors or others who might lack the expertise.

Dr CADx uses a technology that simulates how the human brain works ( deep learning), to recognize patterns that are characteristic of the disease in the images. Once an image is transferred to a computer with the software installed, making a diagnosis is as easy as uploading a photo to Facebook and getting a diagnosis in a few seconds. The current prototype achieves an accuracy of 82% which is an improvement on the 70% average for radiologists.

The system is designed to work with poor internet connectivity opening it up for use in many rural settings in Africa. If developed further, it’s applications could end up being more than just in medical image recognition for disease identification. It is truly an innovative idea that aims to solve problems in the medical sector and I hope that it wins one of the top 3 innovate awards.

US$450 million medical campus to open in 2020

US$450 million medical campus to open in 2020

Kabarak University is partnering with international organizations to develop a 500-bed, state-of-the-art, multi-disciplinary tertiary hospital to be located in Kabarak, Nakuru County.

In addition, the project scope will comprise of a 250 bed Kabarak University Hospital Nairobi and modernization of 23 mission of hospitals under Christian Health Association of Kenya (CHAK). The $450-Million medical campus is expected to commence operations in 2020.

Kabarak University Teaching Research and Referral Mission Hospital’s mission is to build an economically sustainable, center of excellence hospital that will deliver internationally accredited standards of care and is set to become a catalyst for strengthening healthcare services in Kenya, as well as furthering advanced research in the region.

Using the US Green Building Council’s LEED certification program, Kabarak University will design, build, maintain, operate an environmentally sustainable, cost-efficient and energy-saving green buildings. The Hospital Motto is: WE TREAT WITH GOD`S LOVE.

The project which will be set on 100 hectares of land will also develop medical tourism to Kenya leveraging the specialized treatment the hospital will offer.

Kabarak University has picked General Electric (GE) Healthcare to be the technology provider for the project. GE Healthcare will assist the university with infrastructure development, technology transfer, education and capacity building to support a better health system and patient outcomes. The project will be financed by US based Private Equity Sygec international among other stakeholders.

Farid Fezoua, President and CEO – GE Healthcare Africa said: “GE is honored to have been selected to serve as a technology partner to the Kabarak University Teaching Research & Referral Mission Hospital, bringing healthcare infrastructure modernization with a long-term maintenance to help strengthen primary and referral care.”

He added that this further affirmed GE’s commitment to supporting sustainable healthcare development in Africa through capacity building and skills development that are contributing towards nurturing the continent’s healthcare ecosystem.

The Engineering Procurement and Construction (EPC) for the project will include EIFFAGE (French based), EGMF (Belgium) and CMB (Italian).

The proposed Kabarak University teaching research & referral mission Hospital will provide advanced types of care and be capable of diagnosing and treating the most complicated cases. It will include specialities in cardiology and cardiothoracic surgery, cancer, women and child health, stem cell and regenerative medicine, neurology and minimally invasive surgery, with the latest medical equipment such as MRI and CT scanners and nuclear medicine.

“As the first and the only mission referral hospital in the country, we will ensure that Kenyans have access to world-class care locally to reduce medical tourism outside the country,” Dr Henry Kiplagat, The Ag. Vice Chancellor.

Kabarak University will use the hospital to educate and train doctors, nurses, midwives and allied health professionals who are equipped not only to provide excellent care but to lead and transform health care institutions and systems to make them work more effectively for the people they serve.

In addition, by providing a working environment that meets the highest standards, the hospital hopes to attract Kenyan health professionals working abroad to return home, while retaining new graduates who might otherwise have left.

At completion, the project will provide a fully furnished and equipped referral mission hospital that has well trained and experienced doctors and nurses, connected to a network of mission hospitals that will allow world class diagnostic and treatment services through a fully equipped university hospital facility.

Further, Kabarak University Teaching Research and Referral Mission Hospital will be an anchor of medical education and a centre of disease control for Africa that will provide the infrastructure for emergency response to the continent. A properly equipped hospital will provide tertiary care and therefore ease the congestion for the more than 40 hospitals in the southern rift valley, lower north rift valley, central parts of Kenya, and the western region of Kenya as well as Eastern Uganda, southern Sudan and Somalia.

In addition, Kabarak University will establish a welfare programme funded by the university and philanthropists that will help patients who cannot afford the charges to get treatment.

Hollard partners with Cigna to broaden its footprint in Africa

Hollard partners with Cigna to broaden its footprint in Africa

Insurer Hollard planned “significant acquisitions” on the continent in the next few years and was partnering with global health insurer Cigna to offer health insurance to companies operating in Africa, said Brooks Mparutsa, executive director of Hollard’s international business.

Hollard, which already has offices in Zambia, Namibia, Mozambique, Botswana and Ghana, hoped to finalise the acquisition of a health insurance company in Kenya by the end of 2017, Mparutsa said last week. It wanted to secure a life insurance licence in Ghana by August and conclude a transaction in Nigeria in the next 18 months.

Hollard was also in discussions over a possible partnership with Resolution Insurance in East Africa and was keen to do an acquisition in West Africa, Mparutsa said.

Hollard is a privately held insurance company, majority-owned by the Enthoven family, which also own Nando’s.

At the end of 2015, it was SA’s second-largest short-term insurer, with an 11% share of the industry’s total premium income and ousting Old Mutual Insure, previously Mutual & Federal, from this position.

Hollard’s partnership with New York Stock Exchange-listed Cigna, dubbed Hollard Cigna Health, could see it break into a market that rivals have struggled to crack. Hollard is the distribution partner for Cigna.

Liberty Health, which provides medical expense cover to corporate customers in 10 African countries, continues to post losses. For the year to December, the unit’s loss rose more than 100% to R45m. MMI’s health business outside SA has also reported losses, although these narrowed for the six months to December.

The Hollard-Cigna partnership would provide health insurance, approved by in-country regulators, to multinationals operating across Africa, said Jason Stadler, president of Cigna’s international market division. Companies were inadequately served, with providers such as the British United Provident Association and Allianz focusing predominantly on the corporate expatriate market, Mparutsa said.

Hollard Cigna Health would serve expatriates and local employees of multinationals, including local companies with operations outside SA.

Cigna is in a strong position on the continent, having built up a network of 2,000 healthcare providers over decades.

In terms of the agreement, Cigna would be treated as a reinsurer, with a large portion of premium income ceded to it.

Stadler would not comment on the venture’s premium targets, saying only Cigna had “high growth aspirations”. Africa had a low insurance penetration and a growing burden of noncommunicable diseases, he said.

Local delegation to Africa works with Engineers Without Borders

Local delegation to Africa works with Engineers Without Borders

A local team that will be traveling to Uganda on a religious and medical mission met with Roger Ethier, Technical Director of Engineers Without Borders International at the Ranson Civic Center where Either designed pumps for the Community Garden. Ethier invented a solar powered water pump that is lightweight, portable, and can move 180 gallons an hour.

Ether’s engineering skills have been put to the test in some of the most remote and inhospitable locations in the world.

Pastor Tom Snyder and his “right-hand man” Mick Marpole met with Ethier and had many questions. “This could be a life changer,” Snyder said after seeing what the small package could do. The team was able to purchase a pump at a discount with non-profit Engineers Without Borders paying the difference in order to support the mission.

The pump is built to withstand the elements. It will be placed in a part of the world where there aren’t any spare parts or home improvement stores. “This is all prime stuff, the pumps, the relays. They don’t corrode, they don’t fail. The whole idea is (when) we bring them overseas they got to work,” Ethier said.

The pump is AC/DC and can work non-stop using A/C. Using solar power only can produce 720 gallons between charges. That can be used for drinking water, crops, or for the medical team. Many local churches have supported the mission in Africa and purchased land. Some of the land was used to plant corn to feed the orphan children. Water is a necessity in the hot dry climate. The pump can provide water to the dying crop.

“There is nothing like this at all in the market,” Ethier said. He holds the patient on the ‘Lil Sprout Portable Solar Pump’ invention.

“This could be revolutionary getting it into the right hands of the right people,” Snyder said.

Cummings Foundation Donates Medical Supplies to Hospitals in Liberia

Cummings Foundation Donates Medical Supplies to Hospitals in Liberia

In a press conference held at CAF Congo Town office over the weekend, the Executive Director of the Foundation, Fatu Gbedema, named the J.J. Dossen Memorial Hospital in Harper, Maryland County, C.B. Dunbar Medical Center, Gbarnga, Bong County, Government Hospital, Grand Bassa, C. H. Rennie Hospital, Kakata, Margibi County, the Curan Lutheran Hospital of Zorzor, Lofa County and the Gbeapo Health Center in Fish Town, River Gee County as facilities that are expected to benefit.

Madam Gbedema said the donation, which falls under the CAF Health Infrastructure Support Project (CHISP), is part of the foundation’s effort to support and improve healthcare delivery in Liberia.

She disclosed that the distribution of the items, which ranged from comprehensive sets of surgical equipment, catheters, gauze, bandages, examination beds, gloves, gowns medical furniture and consumable and non-consumable medical products, started at the C.H. Rennie Hospital and C.B. Dumbar Maternity Hospital on June 14, 2017; to be followed by the Liberian government Hospital in Buchanan and the Curan Hospital in Zorzor on June 19 and 20, 2017 respectively.

“In spite of the rainy season and the current road conditions in Liberia, CAF is doing everything humanly possible to deliver the last batch of our health infrastructure support project donation to the South East before the 27th of June.

The CAF team will be in Fish Town, River Gee County on June 24, 2017,” Gbedema noted.

She added that as part of monitoring and evaluation mechanisms put into place for the proper use of the items by the hospitals, CAF has included itself, the Ministry of Health, and community leaders in the hospital locales to conduct unannounced spot checks to ensure that the equipment and supplies benefit the estimated targeted one million people whose lives will be touched by the donations.

Speaking at a turn over ceremony at the C.H. Rennie Hospital in Kakata, the Chairman and Founder of the Cummings Africa Foundation, Alexander Cummings, asserted that health is one of the cardinal sectors of the country which needs lot of support and he and his family were glad to help.

“The Foundation’s objective is to empower and uplift Liberians in the health, education and agriculture sectors.”

“The health sector needs lots of support. And I believe primary healthcare is one of the key ways you can help many Liberians,” Mr. Cummings averred.

For her part, the Medical Director of the C.H. Rennie Hospital, Dr. Kumblytee L. Johnson, is describing the donation as a timely intervention, thanking CAF and promised to use the items for the intended purpose.

She explained that the hospital caters to 130 patients daily from across Margibi, Grand Bassa, Gbarpolu and Montserrado Counties, and performs over 25 minor surgeries including cesarean, hernia among others.

“With all what you have given, I am sure that it will help us tackle the problem of delay in catering to the needy people that you have brought these materials for. We assure you that we will use it maximally,” Dr. Kumplytee averred.

The Administrator of the C.B. Dumbar Hospital expressed his gratitude upon accepting supplies from CAF and termed the donation as timely.

Dugbeh Nyan Nominated for AIF Prize

Dugbeh Nyan Nominated for AIF Prize

Liberian medical doctor and scientist, Dougbeh Chris Nyan, is among the top ten nominees for the African Innovation Foundation (AIF) Prize for 2017.

A release posted by AIF online indicates that Dr. Nyan represents Liberia among other African countries, including the Democratic Republic of Congo, Zimbabwe, South Africa, Kenya, Nigeria, Morocco, Egypt, and Uganda.

The AIF includes Dr. Nyan among the nominees for his discoveries in healthcare solutions. He is regarded for developing a new technology for rapid detection of many infectious diseases using only one test.

His profile shows that his discovery of a rapid diagnostic test can detect and simultaneously differentiate at least three to seven infections at the same time within 10 to 40 minutes.

The AIF team is especially interested in Dr. Nyan’s discovery in the healthcare area because it observes that in many African countries, there is a lack of sophisticated diagnostic devices and limited expertise in high-tech diagnostics.

According to AIF, this impedes the clinical decision-making ability of healthcare providers.

“This test provides a solution to this clinical problem, and the innovation is easy to use in any setting and in rural areas,” AIF said.

AIF notes further that the device invented by Dr. Nyan is able to detect and distinguish multiple infections bearing the same symptoms, pointing out cases of yellow fever, malaria, and Ebola as examples.

“Whereas most testing methods take 3-7 days, this device gives test results in 10-40 minutes. This would provide a significant step in the detection and management of infectious diseases on the continent,” AIF noted.

“We are pleased to share with you the names of our IPA2017 nominees as we continue on our mission to catalyze the innovative spirit and unlock untapped potential in Africa.

“For the first time, this year’s nominees include innovators from Democratic Republic of Congo, Liberia, and Zimbabwe. Moreover, given the instrumental role African women play in transforming Africa, it is thrilling to see more women among the 10 nominees with game-changing innovations.

“By providing platforms to recognize innovation excellence in Africa and mobilizing for African innovators, we continue to live up to our credo of engaging, inspiring and transforming. The inspiring stories of these nominees remind us that innovation and African-led solutions are indeed the answer to Africa’s growth and prosperity,” said Walter Fust, AIF’s chairman of the Board.

The nominees will be contending for the award in Accra, Ghana on July 18. According to the AIF release, the innovators have demonstrated incredible proficiency through innovative solutions and addressing challenges in agriculture, value chain, healthcare, energy, communications, service industries, as well as surveillance using drone technology.

The African Innovation Foundation is celebrating its sixth-year Innovation Prize for Africa (IPA) under the theme, “African Innovation: Investing in Prosperity.”

IPA is the premier innovation initiative on the African continent offering a grand share-prize of US$185,000 and incentives to spur growth and prosperity in Africa through home-grown solutions.

IPA has seen tremendous growth in applications and increasing interest from both innovators and innovation enablers over the years. To date, IPA has attracted more than 7,500 innovators from 52 African countries, making it a truly Pan-African initiative. IPA’s 2017 edition witnessed a record number of entries from over 2,530 innovators across 48 African countries. The foundation has supported past winners and nominees with approximately US$ 1 million to move their innovations forward. Due to exposure generated by IPA, past winners have gone on to secure over US$30 million in investments to grow and scale their businesses.

“Over the years, IPA has stimulated impactful and market-oriented innovations aiming at changing lives and transforming Africa. In this sixth edition, we want to promote more investment in home-grown innovations as well as intra-African collaboration and trade to allow the scaling up of viable innovations across borders. We are excited for the opportunity to work with our partners to ensure the innovations of the 10 nominees will be available to African markets and beyond. We invite you to join us and unlock the potential of African innovators, starting by investing in these 10 nominees,” said Pauline Mujawamariya Koelbl, IPA Director.

A new regulatory regime for medicines comes into force in SA

A new regulatory regime for medicines comes into force in SA

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.