Over 100 million euros will be invested by the EU and the Gates Foundation to establish an African drug regulator

According to Reuters, the European Union and the Gates Foundation are due to announce financial assistance for fledgling plans to establish an African medicines regulator to enhance the continent’s drug and vaccine production.

The African Medicines Institution (AMA) treaty entered into force in November, although the agency is now only operational on paper. The treaty establishing the AMA has been ratified by just over half of the 55 African Union (AU) member nations so far.

The provision of financial and technical assistance to the new agency is considered as critical in assisting it in launching operations. This would help the continent’s vaccine and pharma industries, which relies on a reliable regulator to thrive.

A person familiar with the initiative told Reuters that the European Commission, Germany, France, Belgium, and the Gates Foundation will pay more than 100 million euros ($113.93 million) to support AMA and African national regulatory authorities.

The goal is for these organizations to reach Maturity Level 3 for vaccine manufacturing, which the World Health Organization (WHO) describes as “the minimum WHO standard for effective regulatory monitoring for quality local vaccine production,” according to the official.

According to an internal EU Commission paper with slides seen by Reuters, a portion of the funds will be distributed as grants, with the remainder going to the European Medicines Agency.

According to the statement, the EMA, which is now Africa’s only drug regulator, will “offer technical help to African counterparts via scientific collaboration, joint inspections, training, and notably the AMA.”

Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, asked African countries to support efforts to establish the regulator, saying it may aid in the fight against counterfeit and low-quality medications.

“I believe this institution will be extremely essential for the continent,” says the author “In Cape Town, he stated. “I’d like to (appeal) to all non-ratifying countries to ratify and expedite the creation (of AMA).”

Soumya Swaminathan, the WHO’s chief scientist, said the AMA could play “the kind of role that the European Medicines Agency has played in Europe — defining standards, helping countries develop their regulatory bodies” at a previous occasion.

ENDING DEPENDENCE

After the COVID-19 epidemic exposed the region’s reliance on imported vaccinations and other drugs, the race to establish the AMA has begun. Local production accounts for just over 5% of medications and 1% of vaccines consumed by the 1.2 billion-strong population.

Africa initially struggled to obtain COVID-19 vaccine shots due to limited supply being purchased by wealthy countries. Deliveries to Africa have since increased, yet only 10% of Africans are properly vaccinated.

Increased production is currently being pursued, however medicine approval requires the approval of a regulator.

Experts warn that preparing for future pandemics is simply one of the reasons why Africa needs a continental regulator.

Due to inconsistent legislation in 54 countries and a lack of transparency, several pharmaceutical companies have abandoned efforts to register their goods, resulting in limited access to vital medicines in many African countries.

Due to a lack of strict control, counterfeit pharmaceuticals have flooded African markets, resulting in unnecessary deaths and fueling scepticism of medicine.

According to EU officials in Brussels, the EU’s attempt to back the new regulator is part of a larger strategy to counter Chinese and Russian influence in Africa. In the last year, Brussels has provided hundreds of millions of doses of COVID-19 vaccination to Africa.

Vaccine access will also be a major topic at a Brussels conference of EU and African Union leaders.

Margaret Agama-Anyetei, a senior AU official leading efforts to establish the AMA, stated that obtaining more AU member states to sign and ratify the treaty is one of the most pressing tasks.

“There are a plethora of fake certificates, fake drugs, fake masks, and fake medicine across the continent,” she told Reuters by phone from Addis Ababa. “It’s really important that we have a continental agency that is complementary to all other national health institutions and invested in promoting the regulation of medical products across the continent,” she said.

WHO has identified 6 African countries that will receive technology for the production of mRNA vaccines

Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia will be the first six African countries to get the technologies needed to manufacture Moderna vaccines, according to the World Health Organization (WHO).

“At today’s European Union-African Union summit in Brussels, WHO Director-General Dr. Tedros Adhanom Ghebreyesus revealed the first six African countries to get the technology required to create mRNA vaccines. Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia all applied and were chosen as recipients,” Dr. Tedros Adhanom Ghebreyesus, the Director-General, revealed the first six African countries to get the technology needed to create mRNA vaccines. Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia all applied and were chosen as recipients, according to the World Health Organization.

According to the World Health Organization, the Moderna technology hub will assist vaccine makers by providing access to the essential operating procedures and know-how to mass-produce vaccines in compliance with international standards. The centre will also increase production capacity for other medical supplies that countries require to build their health systems, in addition to COVID-19 vaccines.

“The best way to address health emergencies and achieve universal health coverage in the mid- to long-term is to significantly increase the capacity of all regions to manufacture the health products they need, with equitable access as their primary endpoint,” said WHO chief Dr. Tedros Adhanom Ghebreyesus.

President Cyril Ramaphosa of South Africa said: “This is a project that would allow us to create our own vaccines, which is really essential to us. It entails mutual respect, acknowledgement of what we can all bring to the table, investments in our economies and infrastructure, and, in many ways, giving back to the continent.”

According to the announcement, the WHO and its African and European partners will work with the beneficiaries to build a plan and provide the necessary training and support so that the nations may begin vaccine manufacturing soon.

Despite the fact that COVID-19 vaccine supplies in Africa have expanded dramatically in recent months, immunisation rates on the continent remain quite low, with only roughly 11% of the population fully immunised.

Medexpo international trade exhibition for the medical and healthcare industry opens today

The 23rd edition of Medexpo Africa was inaugurated today by Prof. Abel N. Makubi, PERMANENT SECRETARY, Ministry of Health, Community Development, Elderly, Gender and Children in Dar es Salaam at the Diamond Jubilee Hall. The much awaited trade show is open from 10:00 AM to 6:00 PM for the public for 3 days till 19th of February 2022. This premier exhibition for the medical and healthcare industry is the one place to source new products, services and technology from around the world.

The event’s inaugural ceremony was graced by ambassadors from Egypt, USA, Saudi Arabia, India, Korea, Germany and Pakistan along with delegations from supporting organizations such as Tanzania Dental Association, Medical Association of Tanzania, Tantrade & TMDA.

The 3 day international trade event brings to Tanzania exhibitors from various countries showcasing innovative products tailored to the Tanzanian market. The main attraction this time is the Egyptian Pavilion hosting the latest products and innovations from Egypt. Countries participating include Turkey, United Kingdom, United States, Italy, China, India and Spain. Medexpo presents a unique opportunity for all medical and pharmaceutical industry leaders, innovators, business owners, importers, entrepreneurs as well as medical industry professionals like general medical practitioners, surgeons, doctors, physio-therapists, pharmacists, hospital administrators, lab technicians from related industries and backgrounds to source their needs and interact with international brands under one roof.

Prof. Abel N. Makubi in his inaugural address said, “Tanzania has a growing healthcare system. In 2020/2021 the government allocated $387.9 million for the health sector of which $155.5 million will be spent on development projects, which would help the government to implement its health improving initiatives.”

The Tanzania Medical & Healthcare industry continues to be the most exciting and developing sector in the economy of the country, attracting thousands of investors. Tanzania with a population of 60 million also assumes the role of a gateway into the East African Region creating free access to a potential 133 million consumer market which is in demand of products like PPE kits, oximeters, breath analyzers, protective masks, medical gloves & shields, disinfectants & sanitizers, infrared thermometers and other medical safety gadgets.

For more information about this event, please visit: https://expogr.com/tanzania/medexpo/

27 pharma companies will supply generic COVID drugs to low-income countries

Twenty-seven pharmaceutical companies have agreed to produce a generic version of molnupiravir, Merck’s oral
antiviral for the treatment of COVID-19. The agreement will provide affordable access to the drug in 105 low- and
middle-income countries (LMICs) worldwide.

Merck will licence the medication to companies that meet certain quality-assurance standards, according to the
Geneva-based Medicines Patent Pool, a United Nations-backed public health organisation. For as long as the World
Health Organization classifies COVID-19 as a public health emergency, neither Merck nor its development partners will
get any fees from the licences.

Now, 27 firms have met Merck’s requirements: five will make the drug’s basic ingredients, nine will produce the
completed product, and thirteen will produce both.

Merck Executive Director Charles Gore said in a statement, “We are encouraged by the huge number of new and
existing partners who have moved fast to gain a sublicense for molnupiravir through MPP.” “This is a key step toward
assuring global access to a critically needed COVID-19 treatment, and we are sure that the anticipated medicines will be
available in LMICs quickly because manufacturers are working closely with regulatory authorities.”

“Increasing access to quality-assured generic versions of molnupiravir has been a priority for MSD from the beginning,
which led us to partner with MPP on a licencing agreement to expand access to quality-assured generic versions of
molnupiravir, subject to local regulatory authorisation,” said Paul Schaper, Executive Director of Global Public Policy at
Merck. “We’re excited to see this ambition come to fruition, with MPP’s selected generic manufacturing sublicensees
offering a wide range of regional variety.”

The manufacturers involved in the deal are Pakistan’s Remington; Egypt and Jordan’s Hikma; Kenya’s Universal
Corporation; South Africa’s Aspen and CPT,;China’s BrightGene, Desano, Fosun Pharma, Langhua, and Lonzeal; South
Korea’s Celltrion, DongBang, and Hanmi; Bangladesh’s Beximco and Incepta; Vietnam’s Stella; Indonesia’s Kimia Farma;
and 10 Indian companies: Arene Lifesciences, BDR, Biophore, Laurus Labs, Lupin, MSN, Natco, Optimus, SMS, and
Strides.

Merck collaborated with Ridgeback Biotherapeutics and Emory University to develop the medication. Despite a decline
in published efficacy from 48 percent to 30 percent due to new trial results, it got approval from the UK’s Medicines
and Healthcare Products Regulatory Agency (MHRA) in November and emergency use approval from the US Food and
Drug Administration (FDA).

This licencing agreement, as well as one struck by Pfizer for its antiviral, go a long way toward improving parity in
COVID-19 treatment, although the Wall Street Journal recently noted that even reduced prices from generic
manufacturers could be an issue for very low-income countries. In addition, some countries have insufficient testing,
which may prevent the treatments from being used when they are most beneficial.

Strides Pharma Science signs a deal with MPP to market molnupiravir in international markets

Strides Pharma Science has partnered with Medicines Patent Pool MPP, based in Geneva, to commercialise the antiviral medication molnupiravir in worldwide markets.

According to a statement from MPP, the company and its affiliate, Universal Corporation (Kenya), have entered into a voluntary non-exclusive sub-license relationship covering 105 countries.

Strides and UCL will produce the product in India and Nairobi, Kenya, in WHO-approved facilities. One of the two WHO PQ facilities in Sub-Saharan Africa is owned and operated by UCL.

“While our 200mg strength was launched in India under the Stripiravir brand, this partnership will allow us to commercialise the 400mg dose alongside the 200mg dose for global markets, extending significant patient benefits with higher compliance and better administration,” said R Ananthanarayanan, MD and CEO of Strides Pharma Science.

Strides Group would continue to develop and produce high-quality generic medications that will help the healthcare system and patients, notwithstanding the challenging COVID scenario in various regions of the world, it added.

Molnupiravir is an orally given ribonucleoside derivative that inhibits SARS CoV2 replication and has been demonstrated to be effective against the most frequent COVID-19 variations in clinical investigations. Strides acquired an Emergency Use Authorization (EUA) from the DCGI in December 2021 to introduce molnupiravir 200mg in India.

Dar es Salaam to host premier international trade exhibition for the medical and healthcare industry

The 23rd edition of Medexpo will be hosted in Dar es Salaam at the Diamond Jubilee Hall from 17th to 19th of February 2022. The premier exhibition for the medical and healthcare industry is the one place to source new products, services and technology from around the world. The much awaited 2022 edition will be open from 10:00 AM to 6:00 PM for the public till 19th of February 2022. Ambassadors, trade delegations and representatives from various countries and ministries are confirmed to be present to meet and support the companies representing their countries at the event.

As the biggest Medical Trade Event in Tanzania, Medexpo presents a unique opportunity for all medical and pharmaceutical industry leaders, innovators, business owners, importers, entrepreneurs as well as medical industry professionals like general medical practitioners, surgeons, doctors, physio-therapists, pharmacists, hospital administrators, lab technicians from related industries and backgrounds to source their needs and interact with international brands under one roof. The 3 day international trade event brings to Tanzania exhibitors from various countries showcasing innovative products tailored to the Tanzanian market. The main attraction this time is the Egyptian Pavilion hosting the latest products and innovations from Egypt. Countries participating include Turkey, United Kingdom, United States, Italy, China, India and Spain.

Highlighting key sectors to promote and introduce new products equipment and services to the upcoming Ethiopian market is the primary goal for the trade exhibition. This year the participants are bringing to Tanzania – Medical Equipment, Medicinal Food Supplements, Personal Care Products, Medicine and Medical Cosmetics, Hip and Knee Systems, Emergency Medical Systems, Medical Implants And Sleep Apnea Products, Dental Implants, Cleanroom system, Water Treatment System, Injectable & Liquid Filling Compact Line, Autoclaves, Personal Protection Equipment (PPE), Hand Sanitizer Dispenser, Orphan Drugs, Prefilled Syringes (PFS), Products related to Oncology, Cardiology, Nephrology, Interventional Vascular Products, Balloons Catheters and Accessories, Alginates, Silicones, Cements, Plasters, Medical Instruments and more.

The Tanzania Medical & Healthcare industry continues to be the most exciting and developing sector in the economy of the country, attracting thousands of investors. Tanzania with a population of 60 million also assumes the role of a gateway into the East African Region creating free access to a potential 133 million consumer market which is in demand of products like PPE kits, oximeters, breath analyzers, protective masks, medical gloves & shields, disinfectants & sanitizers, infrared thermometers and other medical safety gadgets.

Major pharmaceutical companies and medical equipment and devices manufacturers are already looking for opportunities to make inroads into this lucrative market.

For more information about this event, please visit: https://expogr.com/tanzania/medexpo/

Turkey has pledged 15 million doses of COVID-19 vaccine to Africa

President Recep Tayyip Erdogan stated at a major conference of African leaders that Turkey will deliver 15 million Covid-19 vaccine shots to the continent, calling the continent’s poor vaccination rates a “blot on humanity.”

During Erdogan’s tenure as Prime Minister and subsequently President of Turkey, which began in 2003, Ankara has made significant investments in building trade and diplomatic ties with the world’s poorest continent.

Erdogan told a crowd of hundreds of leaders and ministers that Turkey would provide 15 million doses of the Covid-19 vaccine to Africa, where cases are quickly increasing and immunisation rates are poor.

“We are aware of the global inequity in receiving the Covid-19 vaccine, as well as Africa’s unfair treatment,” Erdogan stated.

Turkey is researching on its own vaccine, dubbed Turkovac, which is currently awaiting emergency use approval.

Erdogan stated that after any approval, it will be shared with Africa.

Turkey’s remarks did not make it clear whether it would deliver certain doses of the globally licenced vaccinations it is presently employing, including those made by Pfizer-BioNTech.

“Within our resources, we plan to share 15 million vaccine shots in the coming months to help to the settlement of this crisis,” he stated.

Soaring infection rates

According to AFP calculations based on government numbers, the number of new infections across Africa has increased by 57% in the last week.

The worst-affected country is South Africa, which was one of the first in the world to be infected with the new Omicron form, which is thought to be even more contagious than previous coronavirus strains.

Erdogan stated that Turkey wished to improve ties with Africa in a variety of areas, including health, defence, energy, agriculture, and technology.

“Our true potential goes much beyond the goals we’ve set,” he remarked.

Turkey and African countries agreed in a final agreement to deepen cooperation in a number of areas, including health, “via more health sector investments.”

“We decided on a road map to improve our relations with the declaration we approved at this summit and the joint action plan,” Erdogan said at a concluding press conference.

Focus on trade

In the last 20 years, trade between Turkey and Africa has increased from $5.4 billion to $25.3 billion (4.8 billion euros to 22.5 billion euros).

Erdogan claimed that it had reached $30 billion in the first 11 months of 2021.

Turkey has set a new trade volume target for the future: $75 billion.

The third Turkish-African summit, which is by far the largest to date, is being attended by 16 African presidents of state and 102 ministers, including 26 top diplomats, according to Turkish Foreign Minister Mevlut Cavusoglu.

Erdogan also met with African leaders one-on-one, including Ethiopian Prime Minister Abiy Ahmed and Nigerian President Muhammadu Buhari, all of whom have showed interest in Turkey’s defence industry.

The next Turkey-Africa conference will take place in an unnamed African country in 2026.

3 million US Dollars boost has been given to a Kenyan medical firm

Revital Healthcare EPZ Ltd, a Kilifi-based medical supplies manufacturer, has obtained a new round of funding from two Japanese companies, allowing it to expand its production capacity.

Revital Healthcare has received a USD3 million (Sh339 million) investment from Asia Africa Investment and Consulting Pte Ltd (AAIC) and Ohara Pharmaceutical Company Ltd.

The Kilifi-based business, which is one of only 25 auto-disable syringe manufacturers pre-qualified by the World Health Organization (WHO) and the only one in Africa, will increase its yearly production capacity from 75 million to more than 400 million.

This comes after the Bill and Melinda Gates Foundation invested Sh440 million in the company, boosting output to at least 300 million syringes per year by 2022, according to the company’s sales, marketing, and product development director Roneek Vora.

Revital believes that the support will result in the development of over 100 direct new employment and over 5,000 indirect new jobs, with at least 50% of new hires being women.

As the global rollout of COVID-19 vaccinations advances, demand for auto-disable syringes has risen.

According to PATH, a global non-profit organisation dedicated to advancing public health, there will be a scarcity of approximately 2.2 billion 0.5ml vaccine syringes in 2022.

In low and middle-income countries, particularly in Africa, this will have a significant impact on the Covid-19 immunisation effort, child immunisation, and inoculation of the new malaria vaccines.

Revital now produces 45 critical medical disposables, including syringes, Rapid Diagnostic Test Kits for Covid and Malaria, Personal Protective Equipment (PPE) kits, surgical face masks, and viral transmission medium kits.

The investment comes at a time when the Omicron variant of Covid-19 is rapidly spreading over the world, causing countries to reintroduce severe measures such as lockdowns in an attempt to limit the infection.

In a statement, Vora stated, “Expanding manufacturing capacity in Africa for crucial goods like syringes is essential to secure adequate supply for the continent.”

He expressed his pride in the company’s contribution to worldwide efforts to guarantee that Africans have access to life-saving immunisation syringes.

Revital Healthcare chairman Rajni Vora stated that the business plans to expand into the diagnostics line, laboratory consumables, and other more necessary medical supplies with the financing from the Bill and Melinda Gates Foundation, AAIC, and Ohara Pharmaceuticals.

President and CEO of Ohara Pharmaceuticals Ltd, Seiji Ohara, stated that the demand for medical syringes that protect African lives against not just Covid-19 but also other infectious diseases including malaria and HIV/AIDS will increase in the future.

“We are committed to and excited about this strategic relationship in addressing the current and future global health crises from Africa,” Handa stated.

Tanzania is establishing itself as a regional medical hub.

Tanzania is emerging as a regional hub for the provision of specialised healthcare services. Dar es Salaam is quickly becoming a destination for patients referred from neighbouring countries.

President Samia Suluhu Hassan has set her sights on making Tanzania a medical tourist destination of choice, having inherited noteworthy achievements in healthcare provision over the past 60 years. President John Magufuli was the one who started talking about the need for Tanzania to tap into the $72 billion-a-year global medical tourism sector in February 2020.

President Hassan pushed the idea even further when she took over. Dr Dorothy Gwajima, the minister for Health, Community Development, Gender, Elderly, and Children, will unveil a medical tourism promotion team in July 2021.

Mohamed Janabi, a veteran cardiologist and executive director of the Jakaya Kikwete Cardiac Institute (JKCI), leads the team. Because JKCI already accepts patients from Comoro, Zambia, the Democratic Republic of Congo, Burundi, Rwanda, Uganda, and Kenya, the government intends to start there.

According to Dr. Gwajima, the government has submitted an application to the World Health Organization (WHO) for Tanzania to be recognised as a medical tourism hub.

More investments needed

Medical tourism’s viability will be determined by Tanzania’s investments in medical human skills development, telemedicine, the digital economy, transportation infrastructure, lodging facilities, health service price affordability, and customer service makeover, among other things.

According to analysts, there is no way around creating a favourable investment climate and a conducive business environment to facilitate the establishment of medical facilities, pharmaceutical and medical equipment manufacturing, and investments in research and development. Following the adoption of the Arusha Declaration in 1967, Tanzania passed the Private Hospitals Regulation Act in 1977, which outlawed private for-profit healthcare providers. This Act was repealed in the 1980s, but investors would need assurance that nothing similar would happen again. However, Tanzania’s medical tourism ambitions are realistic at this point, given that the government has partially reversed its policy of exporting medical tourists to India and other countries.

Dr. Gwajima said in a report on Tanzania’s health sector’s 60th anniversary, which she presented to reporters on Monday, November 8, that in the fiscal year 2020/21, only two patients were referred to hospitals outside the country, compared to 554 in the fiscal year 2015/16. Obviously, the Covid-19 pandemic, which caused global travel bans in most countries and put a significant strain on healthcare services in every country on the planet, contributed to this very small number of patients being referred to more specialised medical treatment outside the country. What is clear is that the number of patients has been declining since 2016, when the government’s efforts to purchase more specialised diagnostic machines and equipment gained traction. According to statistics provided by the then-minister for Health, Community Development, Gender, Children, and the Elderly, Ummy Mwalimu, the number of patients seeking treatment outside the country fell to 350 in 2018 from 550 in 2016.

Future plans

To strengthen Tanzania’s role as a medical hub, the government is installing software programmes in hospitals and improving performance merits through scorecards to overhaul service delivery and professionalism among the country’s healthcare professionals.

When introducing the medical tourism team, Dr. Gwajima emphasised the importance of taking customer service to the next level in order to attract as many patients from outside the country as possible.

The government is also building seven regional hospitals for the new regions (Njombe, Songwe, Simiyu, Geita, Manyara, Songwe, and Mara – Kwangwa), as well as expanding some of the existing hospitals and establishing new departments and services. The government is currently constructing medical oxygen production plants in seven regional referral hospitals (Geita, Manyara, Dodoma, Dar es Salaam-Amana, Mtwara, Ruvuma-Songea, Mbeya).