The registration and maintenance of pharmaceutical products or medical devices in Australia is a complex business, as the medical and healthcare sectors are amongst the most highly regulated and competitive industry sectors.
Our detailed understanding of the pharmaceutical business and the regulatory environment has made us the legal firm of choice for a significant number of the top 10 innovative pharmaceutical companies in Australia and for several Australian and US medical device companies.
Many of our team have science qualifications (including postgraduate qualifications) or pharmaceutical industry experience. This unique combination of in-house scientific, regulatory and legal expertise sets us apart from many other lawyers in this field, and our team's ability to immediately understand what are very often complex issues ultimately saves our clients time and reduces their costs.
We offer the full range of regulatory services, covering regulatory affairs, clinical research, medical affairs and health outcomes. Before and after market launch, we help clients with issues arising at any stage of the product management cycle, including research and development, registration and listing of drugs on the Australian Register of Therapeutic Goods, marketing approval, pricing, labelling, product launch and post-market compliance.
When you need administrative law remedies (for example, appealing against decisions of the Therapeutic Goods Administration refusing to register a new drug), you can rely on our significant experience in section 60 appeals and applications to the Administrative Appeals Tribunal.
"Off-label" Promotion: We advised a pharmaceutical client in relation to whether its proposed use of clinical study results in the promotional literature for one of its drugs would be considered "off-label" promotion, in breach of the Therapeutic Goods Act and the Medicines Australia Code of Conduct. Advice was required on whether the promotional claims that the client wanted to make were within the scope of the product information.
Medicines Australia Code of Conduct: We prepared an appeal in relation to a finding of breaches of the Medicines Australia Code of Conduct by our client concerning a number of its promotional pieces. This involved a detailed review of complex clinical and scientific data to determine whether or not the claims which had been made by our client were adequately substantiated.
Good Manufacturing Practice (GMP) audit: We advised a client in relation to a proposed Good Manufacturing Practice (GMP) audit conducted by the Therapeutic Goods Administration (TGA). We covered a range of issues in our advice, including the powers of the TGA to conduct GMP audits; the powers of the TGA to impose, vary conditions on, or revoke a manufacturing licence; the effect of a revocation or suspension of a manufacturing licence; and possible avenues for appealing a decision of the TGA.
Conduct of clinical trials in Australia: We have provided advice to pharmaceutical clients on various clinical trial agreements and the regulatory requirements governing the conduct of clinical trials in Australia. This has required consideration of compliance issues, local regulatory conditions, local commercial practice and privacy legislation.
Regulation of medical devices: We have advised on the regulation of medical devices in general, and also provided specific advice to a client in relation to their proposed introduction in Australia of an in-vitro diagnostic device (IVDD). This included an overview of the current regulatory requirements for IVDDs, and also the proposed changes to the regulatory framework.
Price reduction requests from the Pharmaceutical Benefits Pricing Authority (PBPA): We have advised a pharmaceutical client in relation to significant price reduction requests from the Pharmaceutical Benefits Pricing Authority (PBPA) for one of its drugs. We developed a range of novel arguments to assist our client in its negotiations with the PBPA, and were successful in helping our client reach a suitable agreement in relation to the price reduction requests.
Section 60 appeal, AAT proceedings and potential Federal Court proceedings: We advised a pharmaceutical client on a suitable administrative law strategy for one of its products in the context of a section 60 appeal, AAT proceedings and potential Federal Court proceedings. The TGA had imposed a condition on the registration of our client's products, amending the text of the product information and cancelling the registration of one of the product's indications. We worked closely with our client to develop a strategy designed to not only maximise prospects of success on the section 60 appeal/AAT proceedings, but also the less adversarial fall-back position of a negotiated settlement with the TGA. This involved first of all working with the client to settle two section 60 appeals, commencing an AAT appeal and then facilitating a series of meetings with key people within the TGA to reach a satisfactory settlement.
Section 60 of the Therapeutic Goods Act: A pharmaceutical client submitted an application for registration of a new chemical entity to the TGA. Its application was rejected, mainly on safety grounds. An appeal submitted by the client pursuant to section 60 of the Therapeutic Goods Act for a reconsideration of the TGA's decision was unsuccessful, viz the Minister's delegate was deemed to have confirmed the TGA's initial decision pursuant to section 60(4) of the TG Act. We represented our client in an application to the AAT for a merits review of the decision of the Minister's delegate, and were successful in reversing the TGA's decision and achieving registration of our client's drug, before the matter proceeded to a full hearing.
European pharmaceutical company: We are representing a European pharmaceutical company that supplies OTC products in Australia. Proceedings have been issued seeking damages for personal injury against the company alleging that the bottle in which the product was supplied and which allegedly broke causing a hand injury to a professional musician was defective; and the company does not have adequate quality control mechanisms and systems to ensure the defects were not revealed.
Compliance with Australian regulatory legislation: We are advising two separate medical device clients and one pharmaceutical client in relation to compliance with Australian regulatory legislation and guidelines relating to their dealings with health professionals and establishing anti-corruption due diligence procedures.
Regulator refusal to approve a prescription pharmaceutical: We represent a pharmaceutical client in administrative review proceedings brought in respect of the Australian regulator's refusal to approve a prescription pharmaceutical in a relatively novel treatment for marketing in Australia.
Negative and misleading representations: We advised a leading pharmaceutical company in a successful complaint against a competitor company as a result of alleged negative and misleading representations to healthcare professionals by the competitor. We successfully obtained undertakings from the competitor in the context of threatened Federal Court proceedings.