VIGILANCE NEEDED TO ENSURE QUALITY AND AFFORDABLE MEDICINES

Recent conduct by several pharmaceutical companies highlights the need for greater vigilance by medicines regulators.

Ranbaxy is one of India’s largest manufacturers of generic medicines and is the majority member of the joint venture that makes up Sonke – a South African pharmaceutical company that holds 1.5% of the national ARV tender.  Ranbaxy has pleaded guilty to criminal charges of selling drugs that were improperly manufactured, tested and stored, and lying about it to the US authorities. A record $500 million in fines and penalties have been imposed on Ranbaxy.

It has also been reported that the European Commission’s competition arm will fine a range of pharmaceutical companies for engaging in illegal agreements that had the effect of delaying access to cheaper generic drugs in Europe. The Commission is reported to have made findings about unlawful conduct by Lundbeck, a Danish pharmaceutical company with a South African subsidiary.  The Commission is expected to announce a significant fine against Lundbeck soon. The legality of these so-called ‘pay for delay’ agreements is also the subject of a case currently before the US Supreme Court and will be decided in the next few months.

These are just the latest in a long series of unlawful conduct by a range of pharmaceutical companies.  For example, last year, GlaxoSmithKline was charged with criminal conduct and fined an unprecedented $3 billion for its illegal conduct. Other pharmaceutical companies that have recently been charged with criminal conduct include:

·      Abbott settled criminal charges in respect of unlawful marketing, paying fines of $1.6 billion;

·      Johnson & Johnson was fined $1.2 billion for concealing dangers associated with one of its drugs;

·      Pfizer was fined $2.3 billion over unlawful marketing of a painkiller;

·      Eli Lilly was fined $1.4 billion in respect of unlawful marketing of one of its drugs.

This kind of conduct by any pharmaceutical company, whether originator or generic, is illegal and must be dealt with swiftly and decisively by the relevant regulators because it has a direct impact on peoples’ access to medicines.  As we put more people on HIV treatment, the state’s limited resources have to go further to meet the needs of all those who require treatment.  If we are to meet the goals of the National Strategic Plan on HIV and AIDS, TB and STIs, greater vigilance is needed to ensure that the focus of regulatory bodies is the need to strive for the progressive realisation of the right to health, guaranteed in section 27 of the Constitution.

SECTION27 and TAC have previously called for the strengthening of the various regulators and the allocation of adequate resources and sufficient human resources to improve their capacity to register and monitor the quality of medicines consumed in South Africa. In this regard, the South African Health Products Regulatory Authority (SAHPRA), which will replace the current Medicines Control Council, has been in the pipeline for many years now.  The Department of Health must finalise the legislative process without delay and set up an independent, efficient and effective SAHPRA that will be in a better position to quickly register new drugs to ensure easier access to medicines and to safeguard public health in relation to all medicines.