12 January 2017

Pharma Costs and Counterfeits

'High Prices in the U.S. For Life-Saving Drugs: Collective Bargaining Through Tort Law?' by Paul J. Zwier in (2016) 17(2) Marquette Benefits and Social Welfare Law Review comments
Sudden exorbitant price hikes to patients who have long taken life-saving drugs are more and more common in today's pharmaceutical market. The anxiety caused to patients who have been prescribed these drugs by their doctors is predictable and severe. Even when initially covered by insurance or through government programs, patients and their families can soon be made destitute by the high copays or caps on payments. This Essay argues that those who buy up life-saving drugs and decide to raise their prices, despite their knowledge of the consequences to patients, are committing the torts of intentional infliction of emotional distress and negligent infliction of emotional distress.
Despite challenges presented by class certification law, these patients should be allowed to qualify as a class for purposes of pursuing a price reduction in these drugs. Through class action collective bargaining, courts can avoid the pitfalls of waiting for piecemeal legislation for consumers of individual drugs and still receive the advantages of free market principled pricing through collective bargaining. And, in combination with legislation, patterned on statutes designed to address bad faith insurance practices, the courts can most effectively moderate high pricing and curtail pricing practices that may otherwise soon bankrupt our-healthcare system.
A different perspective on things that harm and do not work is provided in Health Care Complaints Commission v Attia [2016] NSWCATAD 309, a decision from 23 December last year.

The Tribunal states
Viagra® is widely known as a drug used to treat erectile dysfunction. One of its lesser known uses is for the treatment of pulmonary arterial hypertension. It was as a result of this use that in June 2010 it was discovered that counterfeit Viagra® had been distributed to the Sydney pharmaceutical market.
On 7 June 2010 a pharmacist working at the Sydney Children’s Hospital became suspicious when she noticed that in preparing medication to be given to paediatric patients the Viagra® tablets she was crushing were uncharacteristically gritty. She immediately notified the manufacturer Pfizer Australia. Pfizer determined that the tablets were counterfeit. The Therapeutic Goods Administration (TGA) issued an alert and the licenced wholesaler who had supplied the hospital issued a national counterfeit recall. The Children’s Hospital had purchased the tablets from a licensed pharmaceutical wholesaler which had purchased the tablets from another licensed wholesaler, Hillmear Trading Pty Ltd, which in turn had purchased the tablets from Sajay Rai.
Mr Rai was not licensed to supply Viagra® as required by the Poisons and Therapeutic Goods Regulation 2008 (NSW), or to act on behalf of an entity which held such a licence. In November 2013 he was convicted of two counts of “supply counterfeit therapeutic goods”. One count related to the supply to Hillmear. Mr Rai was subjected to a community service order and required to perform 350 hours of community service.
These reasons concern complaints referred by the Health Care Complaints Commission (the Commission) to the New South Wales Civil and Administrative Tribunal (NCAT) concerning registered pharmacist, Mina Attia, and his part in the distribution of counterfeit Viagra®. At all material times, Mr Attia was the sole director of Hillmear.
Mr Attia does not dispute that, in breach of the conditions of his pharmaceutical wholesaler’s licence, he purchased Viagra® from an unlicensed supplier, namely Mr Rai. He also admits that he failed to ensure that the purchased product was genuine by contacting the manufacturer, Pfizer. In respect of the complaints referred by the Commission, the key factual issues in dispute are:
(1) Whether Mr Attia knew, or ought to have known, that the Viagra® he purchased from Mr Rai was not genuine; and
(2) Whether Mr Attia provided the Therapeutic Goods Administration (TGA) with false and misleading information in the course of its investigation into the distribution of the counterfeit Viagra®.
For the reasons that follow, we find that some of conduct particularised in the Complaints amounts to unsatisfactory conduct and professional misconduct. We have decided to cancel Mr Attia’s registration as a pharmacist and to order that he not apply for review of that decision for a period of 12 months.
Among the fascinating - and perturbing - literature on counterfeit medications see Peter Aldhous, ‘Counterfeit pharmaceuticals: murder by medicine’ (2005) 434(7030) Nature 132; Amy M Bunker, ‘Deadly dose: Counterfeit pharmaceuticals, intellectual property and human health’ (2007) 89 Journal of the Patent and Trademark Office Society 493; Paul Newton et al, ‘Counterfeit anti-infective drugs (2006) 6(9) The Lancet Infectious Diseases 602; Theodore Kelesidis et al, 'Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence' (2007) 60(2) Journal of Antimicrobial Therapy 214; Graham Jackson, Seema Patel and Saima Khan, 'Assessing the Problem of Counterfeit Medications in the United Kingdom' (2012) 66(3) International Journal of Clinical Practice 241; Alexandra Hall and Georgios A Antonopoulos, Fake Meds Online: The Internet and the Transnational Market in Illicit Pharmaceuticals (Springer, 2016); and Roger Bate, Phake: The Deadly World of Falsified and Substandard Medicines (AEI Press, 2011) and Making a Killing: The Deadly Implications of the Counterfeit Drug Trade (AEI Press, 2008).