Industry Q&A with Professor John Skerritt

[caption id="attachment_6159" align="alignright" width="133"] Professor John Skerritt
National Manager of the Therapeutic Goods Administration[/caption]
In this issue’s Q&A, Australian Hospital and Healthcare Bulletin talks to National Manager of the Therapeutic Goods Administration Professor John Skerritt.
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing and its purpose is to protect public health and safety by regulating therapeutic goods that are supplied either imported or manufactured, or exported from Australia. The balance is to ensure all therapeutic goods, including medicines, medical devices, human blood, blood products and tissues are of acceptable standards while ensuring the community has access to new goods within a reasonable timeframe.
Professor John Skerritt boasts extensive experience in medical, agricultural and environmental policy, regulation, research, research management, technology application and commercialization. He tells us about the TGA, its responsibilities and reforms, and its future directions.
You have a strong background in policy, research, regulation and commercialization. What drew you to the role of national manager of the TGA?
While I have worked across a range of areas – medicine, agriculture, food, environment, and international development, my career actually started in the medical research field as a pharmacologist. I have many years’ experience in managing programs and commercialization of in vitro diagnostics, cell culture and instrumentation. Immediately prior to this role I was a Deputy Secretary in the Victorian Government and among other functions, led a number of regulators across agriculture, fisheries and environmental areas – ranging from pesticides, veterinary medicines, animal and plant health, pests and weeds, fisheries, feral animals, and also game shooting. We had over 30 separate Acts to regulate under and an incredibly diverse range of stakeholders – however fortunately in the therapeutic goods area fewer stakeholder carry guns!
In any event, it is pleasing to come full circle and be back in the medical field again. The work that TGA does is tremendously important, I have excellent, dedicated colleagues and with advances such as personalised medicine, smart devices and biological medicines it’s an exciting time to be involved in regulation.
The TGA has many responsibilities, to consumers, to industry and, of course, to the health profession. How do you weigh up that responsibility?
As part of the Australian Government, our primary responsibility is to safeguard and enhance the health of the Australian community through the effective administration of our Act. But we also have a responsibility to help enable that patients have timely access to advances in medicines and other therapeutic products. Doing so can also enable industry to obtain a return on their investments in innovation.
While we have always had responsibilities to each of our three main stakeholder groups in recent times we have recognised that we need to do more to communicate to consumers and health care professions what the role of TGA is and how we manage risk. The interest that consumers have in their health and the health care products they use is only growing and last year we established a dedicated patient contact team to coordinate our almost 200,000 email and phone contacts we receive annually from the public, industry and health care professionals.
The TGA has released the TGA reforms: A blueprint for TGA’s future, to enhance public trust and improve the community’s understanding of TGA regulatory processes and decisions. A plan on delivering the blueprint was released in July 2012. How is that plan progressing?
There are six streams of activity that relate to these recommendations that we’re working on across the organization. These include communication and stakeholder engagement, advertising reforms, complementary medicine reforms, medical device reforms, governance and management and organizational change.
“While we have always had responsibilities to each of our three main stakeholder groups in recent times we have recognised that we need to do more to communicate to consumers and health care professions what the role of TGA is and how we manage risk.”
It’s been an incredibly busy time for all the staff at TGA, as not only are we working on the Blueprint reforms but also continuing with pre-and postmarket regulatory business as usual as well as the large work program required to development the new Trans-tasman regulator, the Australia New Zealand Therapeutic Products Agency .
We have an external governance group, the Australian Therapeutic Goods Advisory Council who review our progress against the reforms at six monthly intervals and advise the Minister on progress, and we also publish our “report cards” twice a year.
There are a long list of reform projects but we are pretty much up to date – a few delays relate to those reforms that require changes to our Act and thus the need to discuss the reforms closely with the new government. In a couple of other areas we decided to pilot things, obtain feedback and modify rather than move directly to full implementation straight away.
In June this year TGA progressed a series of reforms to the complementary medicines regulatory framework. Can you provide a brief overview of this?
The reforms are a response to recommendations from the Auditor-General’s Report on Therapeutic Goods Regulation: Complementary Medicines in 2010. Implementation of some recommendations involves better implementation of existing regulations, others require changes to regulatory framework. One area of work that has already been completed is in making regulatory requirements clearer through extensive updating of the Australian Regulatory Guidelines for Complementary Medicines. We have also strengthened our compliance reviews for listed medicines through development and publication of a compliance review framework and publication of review outcomes for cancelled products.
Some potential changes, that have been under discussion with stakeholders across 2012 and 2013 include clarification of new Evidence Requirements for efficacy or traditional use of complementary medicines and improving the integrity the listing system for complementary medicines through only enabling sponsors to choose from a list of permitted  indications. These are “potential changes” as they require discussion with the new Government and would need changes to our legislation and regulations.
We are also working on improving community understanding of TGA’s regulatory processes and decisions for complementary medicines.
Back to the basics of the TGA. At what point of research or design does TGA get involved in assessing and approving new products?
TGA is not involved in the research or design of products – this begins with a pharmaceutical company or a research institution. Once research and development is complete, clinical trials are conducted. As at that stage the medicine, biological or device is not yet approved for the market TGA manages a clinical trial notification system to enable any Australian-based trial to go ahead. We also have pre-submission meetings with sponsors to discuss their applications.
The TGA’s overall purpose is to protect public health and safety. Is your organisation where the buck stops when it comes to ensuring medicines, medical devices, human blood and blood products, etc, are safe?
It’s certainly true that the TGA’s main purpose is to protect public health and safety. The best way to achieve this is by facilitating working relationships with industry and health professionals so together we can provide high quality, safe and efficacious medicines and medical devices to the public. All regulators have to balance risk and benefit with medicines and other products and so a goal of “ensuring” that every product is free of side effects in every patient is clearly unrealistic. While the buck stops with the TGA in a regulatory sense, it is a shared responsibility - industry is legally required to report adverse events to TGA and we also rely on practitioners to report any adverse events that their patients may have experienced. The best outcome for the public is for TGA, industry and health professionals to continue to form a close working relationship to ensure all aspects of safety are covered.
It must be a challenge to manage time frames for approving therapeutic goods, with pressure to have new therapeutic goods on the market quickly. How do you ensure this happens in a timely yet safe manner?
You’re right, the TGA has a large and complex task in managing the time frames for the large number and diversity of therapeutic goods supplied in or exported from Australia.
Our approach to regulation involves assessing risk, and the amount of regulatory control needed to manage risks depends on the product and determines how consumers gain access to the product. For example, low-risk products such as listed complementary medicines and low-risk medical devices are able to be marketed after listing or inclusion on the Australian Register for Therapeutic Goods based on information submitted by the commercial sponsor. They are thus able to market products straight away but there is a process of postmarket monitoring by TGA of safety issues, and in the case of a complementary medicine, any efficacy claims.
For medium to higher risk products, increasingly we are moving towards graduated assessments based on risk. For example, a much more extensive evaluation is required for a new prescription medicine than for an over-the counter medicine containing a familiar ingredient like aspirin. So for the new prescription medicines – which may require a dozen or more TGA staff undertaking assessment of everything from the toxicology of the active substance in rats, the absorption and distribution in the body of the medicine through to detailed evaluation of clinical trial data, the time frames are longer. But there is still a maximum period of 255 working days for the evaluation to be complete.
How does the TGA manage risk, and compliance of standards and guidelines?
The use of all therapeutic goods carries risk. Australians have a right to expect that in all cases the medicines they take and the medical devices they use meet an acceptable level of safety and quality. One of the roles of the TGA is to regulate therapeutic products based on an assessment of the evidence of the risks compared to the benefits of the therapeutic products. The TGA does this by applying scientific and clinical expertise. We employs Medical Officers, scientists, pharmacists and other highly qualified and experienced staff. The TGA also has access to independent expert advice via a number of advisory committees, which provide us with access to some of Australia’s most eminent and respected clinical and scientific experts. TGA also works to ensure that Australian and international manufacturers operate in a way that results in their products meeting required standards. It conducts regular inspections of manufacturers, both in Australia and overseas, to ensure they continue to meet these standards.
The TGA regulates therapeutic goods before the products reach the market (pre-market) and afterwards, when they are in general use (post-market). At the pre-market stage the TGA acquires the information necessary for a decision about whether or not to register, list or include therapeutic goods on the Australian Register of Therapeutic Goods (ARTG). It can do this through accepting certification, actively evaluating information supplied by sponsors or manufacturers, or by direct inspection.
“Without a doubt, the most significant development that the TGA is involved in is the movement towards a joint regulatory scheme with New Zealand.”
Post-market activities relate to the monitoring of the continuing safety, quality and efficacy of listed, registered and included therapeutic goods once they are on the market. The TGA has a strong pharmacovigilance program, which involves the assessment of adverse events that are reported to the TGA by consumers, health professionals, the pharmaceutical industry, international medicines regulators or by the medical and scientific experts on TGA advisory committees.
What happens when a health practitioner wants to prescribe a medicine or device that is not approved by the TGA?
We understand that in some special cases a patient may require access to a product that is not approved by the TGA. A number of channels exist for this. The first is the Authorized Prescribers Scheme where the TGA grants particular medical practitioners the authority to prescribe a specified unapproved therapeutic good to a patient. The second is the Special Access Scheme which refers to arrangements that provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. The third is through clinical trials, where patients access unapproved medicines or medical devices by participation in a clinical trial and last is the Personal Import Scheme where individuals can import a small amount of unapproved therapeutic goods for personal use.
What do you see as the next most significant development TGA will be involved in?
Without a doubt, the most significant development that the TGA is involved in is the movement towards a joint regulatory scheme with New Zealand. This movement is a logical step in creating a scheme across both countries that will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries. By mid 2016, it is planned that a single regulatory agency, the Australia New Zealand Therapeutic Products Agency, will be in place and absorb TGA and New Zealand’s Medsafe.
More broadly, international regulators are moving towards greater worksharing and harmonization of regulatory requirements. This is critical given the global nature of the industry but it does not mean that the sovereign decision of individual countries to authorize or remove products from the market would be taken away