The pharmaceutical and healthcare industries are highly regulated environments. We are able to advise healthcare service providers on competition issues, business restructuring and reorganisation, joint ventures, regulatory compliance, marketing and licensing, and other commercial issues. Our goal is to help entities in the healthcare sector to deliver on their targets.
Most healthcare practitioners experience uncertainty in interpreting and understanding the complex web of legislation and regulations. The HPCSA has scrapped the ceiling tariffs applicable to doctors’ charge rates. This has implications for doctors, patients and medical schemes. We will be able to give advice and assist if action is required.
We are able to offer advice to stakeholders in relation to all of these regulatory and legislation driven issues, as well as providing advice on the more usual traditional healthcare issues.
There are a number of huge problems currently facing certain practitioners within the healthcare industry. For instance, manufacturers, wholesalers and retail pharmacists have experienced enormous problems since the introduction of single exit pricing and the confusion around professional dispensing fees. We are able to advise retail pharmacists how to overcome these problems with innovative solutions.
Since perverse incentives were outlawed we have been involved in researching the law, codes of ethics and good conduct and regulations in order to find creative solutions to identify ancillary activities which are in line with the required compliance standards, but which enable practitioners to make profits by going beyond their traditional roles. We are working with practitioners and related commercial organisations to develop profitable alternative pursuits, eg with retail pharmacists regarding market research and generic substitutions.
Manufacturers are being required to comply with international price benchmarking standards as regards prices at which drugs are sold to wholesalers and retail pharmacies. This is an area of great importance and we are able to advise you on what is required in this regard.
The new draft National Health Amendment Bill, will, if made into law, enable the Minister to establish a central bargaining chamber to set prices which will be binding on the private sector. There are obviously conflicting interests at play: including the government's stated desire to make healthcare more affordable for the masses, the interests of medical aids who are being forced to supply prescribed minimum benefits, and the interests of practitioners who want to maintain current high standards of practice and earn what they consider to be a reasonable reward for their labour.
This issue has now been put on the backburner, but will no doubt emerge again. We will be able to advise all interested parties as matters develop.
The proposed Medicines and Related Substances Amendment Bill recommends the replacing of the Medicines Control Council (MCC), which regulates the registration and sale of medicines in South Africa, with a South African Health Products Regulatory Authority, which will have a much wider oversight role, over what might even include medical devices, certain foods and dietary supplements and possibly items which could be considered to be cosmetics. This will give the Minister wide powers regarding the registration of medicines and medical products. The Minister, by invoking "national interest", could block the sale of products that have passed standard and usual medical regulatory requirements based on the traditional criteria of efficacy, quality control and safety.
We will be able to keep you advised of developments in these regards.