The Department of Health implemented a policy to accelerate the registration of critical medicines 13 years ago, but since then a flood of generic applications has caused the process to become overloaded.
The fast-track registration, which was introduced in 2003, is for new chemical entities considered essential for national health – which may not be on South Africa’s Essential Medicines List (EML) – and for all medicines on the EML, most of which are generics.
This is in contrast with the fast-track registration policy of many other countries, which is restricted to investigational drugs for diseases for which there are currently no effective or safe treatment available.
The fast-track policy requires the Medicines Control Council (MCC) to register a medicine or reject it (due to safety concerns) within nine months after receiving an application.
The main reason for allowing generic medicine applications to be reviewed and registered like this is to make them rapidly available to the public after the patent on the innovator medicine has expired as generic medicines are far more affordable than innovator products.
Unfortunately, no limit to the number of generics for a particular medicine that can be registered by this fast-track process was specified when the policy was implemented.
This has resulted in a large number of generic applications for the same medicine being submitted and approved for fast-track review status. This has happened even when the MCC has already registered several generics for that medicine. The MCC has only got a limited number of evaluators, causing the fast-track registration system to become overloaded with generic applications and the MCC has been unable to comply with the nine-month deadline for registering or rejecting applications. This has had a negative impact on making critical medicines timeously available to patients.
One such medicine is linezolid, currently used (off-label) for treating drug-resistant TB. The MCC received a fast-track application for the registration of a generic linezolid product in May 2013.
The product was eventually registered in November 2014 – 18 months after the application was submitted – and only after considerable pressure from concerned organisations. The main reason for the delay can be ascribed to the overloaded fast-track review process.
The Department of Health has recognised this shortcoming and the committee within the department’s Essential Drugs Programme that considers and approves applications for fast-track review and last October, it requested a list of registered generics of medicines for which fast-track review has been applied for.
To stop the bottleneck that has developed in the fast-track process due to generics, it is important that the policy be amended to cap the number of generics of a medicine that are allowed to be fast-tracked.
Based on our research, we propose that the number should be limited to a maximum of seven generics per medicine.
Clone applications or autogenerics – generic applications from the innovator companies or their subsidiaries – should be excluded since they can have their applications approved before the patent once their innovator product has expired.
This will give them an unfair advantage over generics from independent companies as they can enter the market with their clones before generics.
We have found a strong relationship between date of registration (and, hence, market entry) and market share of a product and almost no relationship between product price and market share.
A class of affordable biological medicines is biosimilars, which are highly similar (but not necessarily identical) to their corresponding innovators and include biological medicines such as insulin, erythropoietin, filgrastim and growth hormones. These are referred to as first-generation biopharmaceuticals since they were among the first biologicals to be produced by modern biotechnology methods.
Other more complex biopharmaceuticals include trastuzumab (Herceptin) and infliximab (Revellex). In spite of the original first generation biopharmaceuticals being off patent, we do not have biosimilars of these medicines in South Africa even though many countries have them in their markets. The European Medicines Agency registered several biosimilars of first-generation biopharmaceuticals before 2010.
The MCC is currently evaluating medicines submitted as from 2012 with those submitted before then not eligible for evaluation in the current cycle. It is therefore likely that the applications for registration of biosimilars that have already been registered in Europe since 2010 are trapped in the MCC backlog. This means that South Africans are paying high prices for off-patent medicines simply because these products do not have competition from biosimilars.
The MCC should conduct a search among the applications in the backlog to determine if it contains biosimilar applications that have already been registered in countries with whose regulatory authorities the MCC is aligned.
The MCC should also consider changing their First-in-first-out system of review in favour of one based on public health importance of a medicine.
* Henry Leng is at the School of Public Health, University of the Western Cape, Cape Town, South Africa. This article is based on a paper written by Leng, Allyson M Pollock and David Sanders.