Interview: Konji Sebati

What impact will the National Health Insurance (NHI) scheme have on demand and access?

KONJI SEBATI: The implementation of the NHI is aimed at reducing the high cost of private healthcare and ensuring efficient high-quality care in the public sector, and naturally this will increase demand and access in the public sector, including access to innovative and newer medicines and not just generic medicines. It is therefore imperative that both innovative pharmaceutical companies and generic companies are included in the supply of medicines and both play a role in providing for the expected increased demand.

However, in our efforts to improve availability of drugs we must not equate wider access with lower prices. Access is about medicines reaching patients, not just about price and affordability. You cannot narrowly view access as a cheap or a generic drug. A reduction in prices will not increase access by default, as poor management and logistics are still big inhibitors. We need to improve logistics infrastructure and optimise the supply chain at every level to make a material impact on medicine access. Inefficiencies in the supply chain can lead to much higher price-patient ratios, as is seen in Africa, where the price per patient is three times as high as that in Europe.

Sustainable innovation in health requires coordination between health and industrial policy, and between academia and public and private institutions. It is for that reason that innovative pharmaceuticals need to be in an environment conducive to prosperity. Without a robust research-based industry, there will be no generics, which are broadly needed by communities. Robust intellectual property protection is vital as well. Patents are the lifeblood of the pharmaceutical industry. Medicines are usually protected by just a handful of patents, with an effective life span of 12 years, after almost a decade of research and development, 90% attrition rates, and the inordinate amount of time waiting for regulatory approvals. Therefore, the industry has a right to protect its IP and factor this into pricing.

The pharmaceutical industry is also highly regulated and price controls have been in place for some time now, and to date, the single-exit price being used in South Africa has performed well. We are still determining how international benchmark pricing would work if it is implemented.

To what extent does the drug registration process need to be streamlined?

SEBATI: The drug registration process, under the Medicines Control Council (MCC), has experienced a significant backlog, with some drugs taking years to enter the market. The hope is that the new South African Health Products Regulatory Authority will accelerate and streamline the registration process going forward, once it comes into operation.

This will require the training of registration teams and examiners as well as the regulatory staffs of pharmaceutical companies. Perhaps there can be a joint training programme to improve dossiers and expedite registration. Another option is to fast-track those drugs that have already been approved by the US Food and Drug Administration or the European Medicines Agency, rather than going through the whole process again in-country. Lack of capacity and poor logistics drove backlogs at the MCC as well. Therefore there is a need to create different streams when taking in applications.

Overall, how do you feel South Africa is faring in the area of primary health care?

SEBATI: Primary health care development is a pillar of the NHI. We must get our primary health care system working because our tertiary hospitals are overburdened. We must build very strong clinics and community health centres throughout the country, so hospitals are not overwhelmed with mundane cases.