After furiously denying in a sworn affidavit that the government stood in the way of private sector procurement of Covid-19 vaccines, the medicine regulator has just done exactly that.
In early January 2021, Solidarity and AfriForum went to court to challenge the government’s repeated insistence (including in a Covid-19 response presentation delivered on 7 January 2021) that the national Department of Health (NDoH) would retain exclusive control over a centralised vaccine procurement and distribution strategy, under which the private sector or other entities could at best be involved in the rollout as agents of the state.
Two months later, however, they were silenced by an answering affidavit by Sandile Buthelezi, the director-general of the NDoH. It said that there was no case to answer, because nobody other than the government had actually attempted to acquire vaccines and been prevented from doing so by the government’s monopoly claim or vaccine strategy, and besides, PowerPoint presentations weren’t gazetted policy.
This affidavit was widely interpreted (including by the applicants, Solidarity and AfriForum, numerous media outlets, and in this column by yours truly) as an ‘admission’ that it was legal for the private sector and other entities such as provincial governments to acquire and distribute vaccines independently of the government’s vaccine strategy. The applicants duly withdrew their case.
Like everyone else, I erred in this interpretation. A closer reading of the affidavit shows a more nuanced (or rather, dissembling) assertion: ‘[The applicants] place no evidence at all before this Court that private persons or provincial health departments are seeking to procure the Covid-19 vaccine themselves but have been precluded from doing so by the Covid-19 Response presentation or Government strategy.’
That doesn’t mean it would be legal if they did. It just means they didn’t, so the legality of doing so is irrelevant.
It also says that neither applicant provided any evidence that provincial health departments wish to procure, distribute or administer Covid-19 vaccines outside of the national government strategy and has been precluded or even inhibited from doing so by the Covid-19 Response presentation or any national government strategy.
It goes on to say that ‘there is presently no realistic way in which private persons or provincial health departments could procure the Covid-19 vaccine themselves’ (my emphasis).
So, this is not an admission that they would not have been precluded from acquiring had they in fact sought to do so. It merely states that there is no case to answer, because: ‘There is … no tangible or justifiable advantage for the applicants which would result from the relief sought being granted and the relief sought would have no practical significance or [sic] them.’
Well, that was then. This is now.
By early March, when the answering affidavit was filed, the AstraZeneca vaccine had been authorised for use by the NDoH under a section 21 authorisation, which permits the use of unregistered medicines in certain limited and specified cases. The Johnson & Johnson vaccine had only been authorised as part of an implementation trial involving healthcare workers. No other vaccines had been authorised under any conditions.
On 1 April 2021, however, the South African Health Products Regulatory Authority (SAHPRA) announced that the J&J vaccine had been registered, but with conditions. Those conditions include ‘that the vaccine is supplied and administered in accordance with the NDoH Covid -19 vaccination plan and applicable guidelines’.
Late last month, the Premier of the Western Cape, Alan Winde, told me that the provincial government has a mandate to be responsible for public healthcare, and that in pursuit of this mandate, his cabinet had decided to procure vaccines, had budgeted for them, and had established a procurement team to source vaccines to cover any shortfall that national government is not able to supply. The only obstacle was SAHPRA approval.
He said the team had approached 28 different pharmaceutical companies about acquiring vaccines, and a few of those prospects look promising. Two companies, namely J&J and Pfizer rebuffed the approaches ‘for now’, claiming that ‘at the moment’ they are dealing with national governments only.
Winde also told me that companies in sectors such as agriculture and retail were ‘very keen’ to acquire and distribute vaccines, especially to customer-facing employees and staff who need to work in close proximity to each other.
This means that the basic claims of the government’s answering affidavit in the Solidarity/AfriForum case have now been invalidated. There are now provincial governments and private sector companies who want to, or have tried to, acquire vaccines, and the first SAHPRA vaccine registration now explicitly forbids them from doing so.
The government’s representations to the court make several claims about the supposed harm that would ensue if it did not have a monopoly on procuring and rolling out vaccinations.
These include the claim that more buyers in the market would drive up prices and reduce supplies, that private procurement and rollout would benefit the rich but prejudice the poor and the vulnerable, and that it would ‘create chaos’ and put lives at risk because of ‘uneven vaccine distribution’.
These objections are largely nonsensical. While supply is fairly constrained, additional orders of a few tens of millions will not block similar acquisitions by the NDoH itself. Nor will such limited orders make a significant impact on the price. In fact, vaccine prices are widely expected to fall, not rise, as global production ramps up to meet demand.
If the private sector or provincial governments were to vaccinate people who are not yet eligible for vaccinations under the government’s rollout strategy, this would not prevent the government from continuing to prioritise and immunise the most vulnerable segments of society. Vaccinating an employee without comorbidities, or a healthy private patient, in no way prejudices anyone else.
In the pursuit of herd immunity, every additional vaccination, no matter how ‘uneven’, contributes to the goal, and protects not only the vaccinee, but also anyone that the vaccinated person comes into contact with. In addition, every vaccination conducted by entities other than the national government reduces the burden on the national government and makes another of its vaccines available to someone else.
As for putting lives at risk, the government’s own vaccine strategy does that already. Supplies are limited and sporadic shortages are common. Government’s rollout plans are better described as aspirations or wishful thinking. It has already missed its original targets by a long way, and there is literally no chance that the government will meet even its most pessimistic revised vaccination objectives.
It could therefore be persuasively argued that continuing to depend entirely on the NDoH for the country’s vaccine rollout will put significant numbers of lives at risk, including from new mutations.
Permitting provincial governments and the private sector to lift some of the burden from the national government’s shoulders would hasten herd immunity and save lives.
I do not know of any precedent for registering medicine with the condition that only the NDoH may control its acquisition and distribution. It’s not like vaccines are Schedule 8 drugs.
Inasmuch as SAHPRA’s arbitrary restriction prevents people from acquiring vaccines for themselves, it is unethical. It leaves people at risk who otherwise could have been protected from the disease.
The national government’s ideological desire for centralised control is going to cost lives. It is high time someone went back to court – ideally with a somewhat better-conceived case than AfriForum and Solidarity were able to prepare – to challenge vaccine registration conditions that prohibit the provinces and the private sector from acquiring vaccines on their own account.
Who is up for the challenge?
The views of the writer are not necessarily the views of the Daily Friend or the IRR
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