In my quest to break into the Regulatory Affairs department within a prescription pharmaceutical industry, I enrolled in the postgraduate course in Pharmaceutical Medicine. My first class is on Law, Ethics and the Regulation of Medicines and my very first module was on The Australian Legal System.
After a read of the case Phytologic Pty Limited v the Secretary, Department of Health and Ageing, I agreed with the Secretary’s decisions and essentially agreed with one of the court’s statement that “The existence of provisions for review does not imply a requirement to make a decision considering the review time frame”.
In my analysis, I was considering the fact that the TGA had found that Phytologic had not complied with the requirement under s 26A(2)(j) of the Therapeutic Goods Act to hold evidence supporting indications and claims made for their product. I also considered the fact that Phytologic was provided several opportunities during which they failed to convince the TGA to be able to continue listing their product on the ARTG. Considering the finding that they did not comply with the requirements set by the TGA, taking a holistic point of view, and considering all of the above to be true, I concluded that I agreed with the decisions of the Secretary.
My way of thinking has changed since then.
I didn’t consider at that point that there is a possibility of the process of evaluation itself being flawed or an error on the evaluator’s end.
Mr. Allan Anforth, our lecturer for the Law module, also pointed out among other things, the possible financial loss a company can incur even if the TGA’s decision was reversed in such a case where they have already been advised to take goods off the market before the appeals decision is made.
In the complex procedure of reviews of medicines, there are a number of things that could possibly go wrong on the end of either sponsor/applicant or TGA. Checks and balances are important, and section 60 of the Therapeutic Goods Act gives the sponsor a powerful tool of being able to appeal decisions made by the government body. This right of appeal should not be encroached upon.
I realised that while doing the Law module, it would serve me best as a student to think of these scenarios from a strictly legal perspective. Perhaps while doing a different module on say, Ethics, it would be good to critique a decision from an ethical point of view. This will help me as a professional, to be able to look at the same situation from various angles, weigh out potentialities and possibilities, and make the best decision. Having completed this assignment, I feel that I’m better equipped in terms of knowledge and learning about legal procedures. Confucius might have said that I gained wisdom in this matter by the bitterest method of experience!
- Federal Court of Australia (2012). ‘Phytologic Pty Limited v the Secretary, Department of Health and Ageing, Commonwealth of Australia  FCA 1407 (13 December 2012)’. Retrieved 21 August 2016.