How SA regulates medicines and vaccines
COVID-19 has raised public awareness about the role of national medicines regulatory authorities in enabling access to safe, effective and qualityassured medicines. This includes vaccines.
In South Africa, the pandemic has also exposed several important misperceptions, among the public and health professionals.
The South African Health Products Regulatory Authority (Sahpra) is responsible for monitoring, evaluating, investigating, inspecting and registering all health products. These include medicines for human and animal use, medical devices and diagnostic tests.
The authority is an independent structure, located outside the Department of Health and the public service. Funded by a combination of user fees and fiscal allocation, with a small contribution from donors, it is accountable to the minister of health.
Regulatory bodies vary around the world, but the structure of the South African authority is now closer to those of other major regulators. The decisionmaking power is vested in the chief executive officer, who can appoint a range of technical advisory committees to make recommendations to inform regulatory decisions. Members of the advisory committees are drawn from academia and private practice.
Examples of regulatory decisions include:
¡ Registration of a medicine or vaccine. Registration is required before a medicine can be marketed. ¡ Approval to conduct a clinical trial in human volunteers of an investigational vaccine. ¡ Approval of compassionate access to an unregistered medicine. This is done on the basis of motivation by an authorised prescriber or the Department of Health. National medicines regulatory authorities can also be proactive. For example, they can provide advice on regulatory standards. The authorities can also engage with applicants as they develop new products. For example, regulators have communicated in advance about the targets for the efficacy of Covid-19 vaccines.
The authority has also contributed to global regulatory efforts. And it is doing rolling reviews of two Covid19 vaccines (Novavax; Johnson & Johnson) and is assessing a dossier for another (Pfizer). It has also approved imports of the vaccine (Oxford/AstraZeneca) which is being manufactured in India, even though it hasn’t yet been registered. It’s awaiting submission of a full dossier on the vaccine.
South African authority
By law, Sahpra is constrained to consider only three factors when it makes decisions: quality, safety and efficacy.
Quality refers to the batch-to-batch reliability of the regulated product. This takes into account how it is made, packaged and distributed. Quality must be demonstrated at the time of registration. It must also be assured throughout the life cycle of the health product. Life cycle refers to the entire time that a product is marketed.
Every medicine is associated with desired and undesirable effects. The safety assessment relates to the undesired, adverse effects, and whether they are proportional to the proposed use. For example, a treatment for a severe and potentially fatal disease may be associated with serious adverse effects. But, on balance they may be considered acceptable.
On the basis of safety considerations, medicines can be restricted to prescription-only access, or pharmacist-initiated sale, or placed on the market for general sale.
In some cases, a formal post-registration obligation is placed on the applicant. Examples include research on use in children. But most post-registration safety data comes from spontaneous reporting by health professionals and patients. Anything reported to the manufacturer must be reported to the regulator.
Efficacy data describe whether the medicine achieves its proposed purpose in preventing or treating a disease or symptom. The data also shows whether there are important differences in effect between patient groups, for example, if it is affected by age or sex.
Importantly, there are certain things the regulator is excluded from factoring in. These include:
¡ The price of a medicine.
¡ Its cost-effectiveness to the health system, or its affordability. This responsibility lies with the minister of health and a pricing committee.
The process
In the case of medicines and vaccines, the starting point for the regulator’s assessment is the dossier submitted by the applicant. This is a comprehensive and exhaustive submission of the evidence of quality, safety and efficacy.
After initial screening, the elements of the common technical document are referred to specific evaluators. These are often external people or technical advisory committee members. Their assessments, after peer review and sometimes committee deliberations, inform the eventual regulatory decisions.
The final decision to issue a certificate of marketing authorisation is accompanied by specific conditions, approval of the professional information and patient information leaflets, and an approved proprietary (brand) name for the product.
Lastly, each batch of biological medicines, such as vaccines, is tested at the National Control Laboratory for Biological Products.
Many of the assessments conducted by Sahpra may have been done by a regulator in another country. To avoid duplication, and speed up decision-making, regulators engage in what is called “reliance”. They enter into agreements to share information and co-operate in making regulatory decisions.
In a minority of applications, South Africa’s regulator can “rely” on prior decisions taken by well-resourced and mature regulators, and focus its efforts only on issues that are specific to circumstances in the country.
Sahpra’s response to Covid-19 has been questioned. Advocates for medicines that are unregistered in South Africa have accused the body of not being proactive in bringing such products to market and approving their use. But an applicant is required to provide a quality-assured product and to be held accountable for meeting those standards. The authority can’t approve a product in the absence of an appropriate applicant.
The body has also been criticised for not conducting clinical trials to provide evidence of safety and efficacy. Again, its role is to regulate such trials, not to conduct or fund them.
Meeting mandates
National medicines regulatory authorities are gatekeepers that protect the public from unnecessary harm from health products. They do so in the best tradition of the injunction to “do no harm”. But in doing so, regulators must restrict the freedom to make, sell or use such products.
Sahpra can only respond by being true to its mandate, transparent in its decision-making and scrupulously reliant on the scientific evidence. | theconversation.com
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FRANCE faces a political hot potato if the United Nations Human Rights Council (UNHRC) agrees to probe complaints about unfair and targeted attacks on Islam and Muslims.
The complaints arise from a carefully co-ordinated campaign by a coalition of human rights and civil society organisations who have petitioned the UNHRC to investigate the Macron government’s discrimination against Muslims.
France stands accused of systematically entrenching Islamophobia by placing the entire Muslim community under the radar on suspicion of being the “other”.
The daring move to invoke the UN charter and find France’s ruthless attacks to be in violation of it, comes in the midst of a sweeping crackdown on the Muslim community by the French state.
TRT media reveals that the complainants comprise 36 organisations from 13 countries, and takes aim at what it says is a campaign by authorities to carry out “illegitimate and violent raids” on Muslims’ homes and NGOs in a bid to “send a message”.
Among the signatories are the Council on American-Islamic Relations, the Islamic Central Council Switzerland and the Muslim Association of Britain.
Evidently the pretext for the latest intense round of anti-Muslim hate speech emanating from Macron’s mouth is the killing of high school teacher Samuel Paty for showing Charlie Hebdo caricatures of the Prophet Muhammed (pbuh).
The extreme measures adopted by France led to the forcible shutdown of Baraka City, the country’s largest Muslim welfare organisation. That it was done without any judicial oversight is a serious violation of civil liberties.
And to further demonstrate Macron’s vicious onslaught, the home of the founder, Idriss Sihamedi, was raided by security forces. In subsequent media interviews, Sihamedi described the raid as an act of intimidation.
The outrageous assault on Muslims and Islamic organisations is described in the petition to the UNHRC as “racist and Islamophobic”.
In a detailed report published in TRT, a long list of grievances underlines that security forces have often broken into the homes of mosque leaders, intimidating their children. In one case, police are accused of raiding a mosque in a bid to count which children were learning Arabic and whether they wore the headscarf.
“The French government deliberately
and systematically undermines and violates fundamental civil liberties and human rights, targeting and violating the rights of even the children,” says the petition.
The signatories also take aim at the Macron government’s wider anti-extremist agenda which it says “is solely focused on consolidating the government’s political, ideological, theological and financial control of Muslims”.
Advocate Feroze Boda of the Muslims Lawyers Association of South Africa who compiled and submitted the complaint on behalf of the petitioners, says the complaint is a call for “accountability and positive change” aimed at the “dismantling of pervasive hateful policies against Muslims in France”.
“France has seen shocking levels of state-sanctioned Islamophobia in recent months. This has precipitated the closure of mosques, Muslim schools, Muslim-led charities and civil society organisations,” is the view of Muhammad Rabbani of the UK-based human rights organisation CAGE.
“France cannot be allowed to infringe upon its international rights obligations so openly, and yet present itself as the land of ‘liberté, égalité, fraternité’,” declares Rabbani.
That the broad coalition of Muslim civil, professional and legal groupings have adopted this route underlines the fact that “there is no real or effective remedy within the French legal system to stop the French government”, say the petitioners.
In being confronted with the complaint the UNHRC faces challenges which hinge on its credibility as an effective arm of the UN.
Will it dismiss it out of hand or will it drag its feet by muddying it through unnecessary bureaucratic measures?
Indeed to fulfill its obligation as the international arm of the world body, it is reasonable to demand that the UNHRC assigns a special rapporteur to immediately commence an investigation.
Islamophobia is a hallmark of hate and to ignore its devastating effects is to reward purveyors of racism, intolerance and bigotry.