Recent statements by the South African Health Products Regulatory Authority or SAHPRA, the successor to the Medicines Control Council, that it intends to levy a so-called "backlog fee" must be viewed in the light of the provisions of the Medicines & Related Substances Act No. 101 of 1965, as amended.
This approach is required as SAHPRA is a creature of statute and as such is bound by the legal provisions affording it powers and functions. The extent of the backlog, presumably, in applications before SAHPRA for registration of medicines is largely unknown but delays in the processing of applications are common place.
The levying of fees in respect of applications for the registration of medicines is governed currently by regulations promulgated in terms of the Medicines Act.
The fees are published by the Minister of Health pursuant to his powers in the Medicines Act and relate certain types of applications. A backlog fee is not contemplated in either the Medicines Act or the regulations setting the fees that may be lawfully charged by SAHPRA to fulfil its functions vis-à-vis applications lodged with it. The Medicines Act also contemplates certain categories of fees and, once again, a backlog fee does not feature in that suite of fee categories.
Even if one were able to locate a potential section of the Medicines Act to support the imposition of a backlog fee, the rationale for imposing, fundamentally, a penalty on applicants in respect of circumstances beyond their control must be interrogated with reference to the principles of legality and reasonableness emanating from the Constitution.
Viewing the backlog fee through a constitutional lens, the existence of such a fee is at odds with the principle of legality as the legislative support for imposing such a fee is entirely absent.
In addition, such a fee is at odds with the description of the functions of SAHPRA in the Medicines Act, which include to "ensure the efficient, effective and ethical evaluation or assessment and registration of medicines, medical devices and IVDs that meet defined standards of quality, safety, efficacy and performance, where applicable" (my emphasis).
A backlog fee is therefore a legally inappropriate measure to address delays in applications being processed by SAHPRA, whose lawful mandate is otherwise clear.
Written By Neil Kirby, director and head of healthcare & life sciences practice at Werksmans Attorneys