For the past 16 years, Pharma Dynamics has been increasing access to affordable, effective healthcare in South Africa, making it a prime player and analyser of the country’s pharmaceutical and healthcare infrastructure; especially in the aftermath of the Medicine Control Council’s (MCC) delayed launch of SAHPRA.
The ‘South African Health Products Regulatory Agency’ has been eagerly anticipated in the country over recent months, leading to an ongoing ‘sector woe’ within the pharma domain. As a long-time facilitator of increasing access to healthcare in South Africa though, Pharma Dynamics is keen to see a drastic remodelling of the public sector’s infrastructure and investments made within it; driven by agencies lie SAHPRA.
“Since 2012, Pharma Dynamics has been South Africa’s leading supplier of cardiovascular medicine, both in terms of value and volume. Today we are active in more than 27 therapeutic areas which, among others, include cardiovascular, central nervous system, allergies, cold and flu, acid reflux and anti-microbials,” explains the Company’s Chief Executive Officer, Erik Roos. “We also own 11 market-leading brands and remain the county’s fastest growing generic pharmaceutical company.
“We recognise that medication in isolation does not address the burden of non-communicable diseases in the country holistically. Pharma Dynamics thus invests in several corporate social investment initiatives that are geared to motivate South Africans to make healthier lifestyle choices and to provide educational material and support to patients across several therapeutic areas.”
The Company’s influence on the sector increased dramatically in 2015 following the acquisition by Lupin Laboratories, making the enterprise not only more impactful from an investment and sourcing perspective, but even more aware of the global industry situation and how a system like South Africa’s needs improving in order to achieve long-term sustainability.
“I’ve been in the pharma industry for 25 years and I have been privileged to be involved in various sectors in the sub-Saharan African healthcare environment. I’ve held senior roles in generic, originator or so-called ‘brand name’ pharmaceutical companies and the dental industry,” Roos notes. “I now look forward to evolving the generics industry in South Africa and to engage in much needed education around the quality and cost saving potential of generic medicine and by implementing sustainable strategies in this regard.”
Ensuring efficient operations
And when it comes to sustainability, the delay in transitioning from the MCC to SAHPRA is something that Roos feels is a delay for improvement, not just for transference.
“The Medicine Control Council of South Africa is responsible for the registration of branded and generic medication, but due to challenges such as a scarcity of skilled staff and resources, the body has fallen behind on registrations and has a backlog of three to five years,” he explains. “This is why the South African Health Products Regulatory Authority is being established to take over from the MCC, since the MCC in its current form has struggled to cope with the volume of applications it receives for new medicines and clinical trials.
“Unlike the MCC, SAHPRA will be a parastatal that will be funded through increased costs for new product registrations paid by the industry. SAHPRA will also have an independent CEO to ensure efficient operations.”
Roos believe that this delay in incepting SAHPRA will result in a smaller variety of molecules being made available to the broader population, including generic medications which have the potential to save patients as much as 80 percent on their medicine spend. In slowing down the saturation of new products into the market, it is also set to hinder the level of competition in the market that helps to keep medicine costs down.
“Less access to variety means less competition and ultimately means the cost benefits for patients are not realised,” Roos affirms. “In terms of the effects on the pharma industry, the long timeline to register products could hamper investments from companies, because the exorbitant cost of acquiring new products must be recouped within a set amount of time to make the investment a viable venture.
“In light of this, the delay in new product registrations again boils down to less variety for the patient if companies view it as too risky to attempt new registrations.
“Secondly, many national pharma companies are owned by global holding companies that can support them financially while they wait for their investment to bear fruit, but smaller companies don’t have this luxury and may need to pack-up shop if their initial investments do not become profitable in time. This also drives down the competition in the industry.”
A holistic healthcare approach
There is of course also the concern that the multinational strand of the sector could look elsewhere for more efficient and cost effective operations and product registrations in the future, and it is the amalgamation of pivotal setbacks which emphasise how far the public sector has to come in order to match its private counterparts.
“We have a very well established private healthcare sector, which I see as an integrated model that sees increased associates and partnerships between the supplier, manufacturer, funder and providers (doctors and pharmacists),” Roos says. “The public sector on the other hand needs a dire remodelling and infrastructure investment to revitalise it. Sadly, this sector services the vast majority of the South African population when it comes to basic healthcare needs.
“In order to address the inequality in access to healthcare, the Department of Health (DoH) envisions National Healthcare Insurance (NHI). This will demand significant collaboration and partnerships between the private and public sectors if a truly effective model that will serve the need of the people is to be established.”
A substantial staff and skill shortage will also need to be addressed within the public sector for this to be brought to fruition; subsequently instilling a holistic approach towards creating sustainable healthcare provision long into the future.
Roos concludes: “A holistic healthcare approach is needed to sustain the relationships between all role-players; from the DoH and SAHPRA, right through the integrated chain of suppliers, manufacturers, funders and providers.”