As a general medical practitioner with a long experience in the pharmaceutical industry including public policy, advertising, marketing and regulatory issues and a post graduate training in traditional Chinese medicine, what made you decide to join ASMI as a Scientific Director in 2004 and Executive Director in July 2010?

My first role in the Australian Self-Medication Industry (ASMI) was in the advertising pre-approvals area. Australia has a therapeutic goods advertising code to which all medicines directed at consumers have to comply. Advertisements that are intended for publication or broadcast in mainstream media like newspapers, magazines, and television require pre-approval. That is a co-regulatory function, a government function that has been delegated to industry. That was my first role with ASMI for three years.

Then I worked in advertising and medical education agencies for three years, which provided me with very valuable marketing & commercial experience. In 2004 I returned to ASMI in the regulatory & scientific affairs section, and when my predecessor decided to retire two years ago, I stepped in as executive director.

Could you give our readers an overview of key achievements and milestones since you took over the position in 2010?

We conducted a comprehensive survey of our membership which resulted in the implementation of strategies to further enhance the profile of ASMI with Government and stakeholders and to strengthen service delivery to our members. We are in the process of building our resources to support these initiatives.

What are the current priorities of your agenda, in terms of focus areas and collaborations with private and public institutions?

The main priority for us is regulatory reform in a range of areas. The first is a review of business processes in the OTC area of the TGA to streamline the processing of product applications. The aim is to provide greater predictability, clarity and transparency in relation to regulatory decision-making.

We are also working with stakeholders to further strengthen the regulatory framework for complementary medicines, even though Australia has, together with Canada, probably the most advanced regulatory schemes for complementary medicines.

Another area of focus is to encourage investment in research and innovation. In the OTC space this occurs through the switch, or down-scheduling from prescription to OTC status.. The switch environment in Australia is conservative, and ASMI is trying to change that in order to increase access to medicines to support greater self care.. We work with pharmacies to expand their professional role, so that they have a greater role to play once more medicines switch from S4 (Prescription Only) to S3 (Pharmacist Only).

Regulatory impediments need to be removed and we we have renewed our efforts to pursue the implementation of data protection and market exclusivity for OTC and complementary medicines. . IN the EU there is provision for one year data protection for switch. We would like to expand that model to provide for longer periods of market exclusivity based on the quantum of the investment and the nature of the regulatory data required.

The second key strategic priority for ASMI is to gain broader acceptance of the role of self care in personal and public health. The objective is to empower consumers to take a greater role in maintaining health, preventing disease, and in disease management. The ageing of Australia’s population and increasing burden of chronic disease mean that expenditure on public health will be unsustainable at current levels. One of the ways to decrease the burden for the public healthcare system is making people more responsible for their health.

Which are the strategic pressure points in encouraging consumers to self-medicate and focus on prevention? How do you further educate consumers/ practitioners/ pharmacists of the need for a developed self care industry?

The key to greater self care is health literacy and the biggest challenge is is to support and empower consumers to take more responsibility for their personal health and how to make the best use of scarce healthcare resources. Industry role is to provide safe and efficacious medicines and evidence-based information about those products and the conditions they are targeting. ASMI believes that pharmacists need to play a bigger role to play in primary healthcare service delivery. We are working with the Pharmacy Guild of Australia as well as with the Pharmaceutical Society of Australia to increase their role in the management of minor ailments. Increasing access to medicines through switch is an important part of providing pharmacists with the tools to expand their professional service capacity.

Juliet Seifert told us that “Behaviour change is one of the things the Jesuits told us years ago that is difficult to achieve after the age of six” explaining to us the creation of the partnership between ASMI and Life Education for the development of “medicines matter” program. What is your opinion on the matter?

We have continued our support for Life Education through a further three-year grant and through continued support for their programs to increase the awareness among kids on how to use medicines appropriately. At the moment we are looking at how to strengthen health education in the school curriculum. Work is is already under way, but the industry obviously has its contribution to make in that area, especially in relation to the quality use of medicines.

Adult education is always a challenge. There are people that can recognize the symptoms of minor ailments and know how to manage those ailments safely We plan to conduct research to gain a better understanding and to learn from those people who already practice self care safely. This will inform programs to encourage others to follow.

As an association which embarques over 85% of the OTC market by volum in Australia, how well positioned do you see ASMI to liveup to its mission of being the representative voice of the consumer self care products industry? Points of improvement?

ASMI is very well positioned. The association has a history dating back to 1974, and we have had some significant milestones and achievements over the years. The association has built up a lot of credibility as evidence-based and committed to playing its role in public health and improving the health of Australians. Today ASMI is in good shape and in a good position to achieve our mission.

What are the main challenges and opportunities faced by ASMI members, in a $3 billion over-the-counter market with a fifth of total GP consultations involving minor ailments? (the efficacy concerns surrounding OTC medicine) How does the industry deal with the increased attention and tougher scrutiny (the topic of the last article in your research)?

The area with most significant growth is complementary medicine. About two-thirds of the Australian population now use complementary medicine on a regular basis, and we are going through major ongoing reforms in that area. It would be critical to maintain public confidence in the regulation of complementary medicines to sustain growth opportunities. Growth in the OTC market is probably not as strong. Earlier I mentioned the opportunities for medicines to switch from S4 to S3, but we need the right regulatory environment to facilitate that. It is a huge impediment to investment if companies make an investment to switch and then competitors can enter the market basically on the coat tails of the innovator.

An unprecedented range of reviews and reforms are either underway or planned for the next 4 years We are right in the midst of the biggest labeling and packaging review in the past decade. I mentioned complementary medicines reforms before. The promotion of medicines and devices to healthcare professionals has come under public scrutiny and the various industry bodies are the process of revising their codes of practices to strengthen self regulatory control. A review of advertising arrangements and the scheduling framework will occur in 2013. There is a strong drive to increase transparency in relation to regulatory processes aimed at providing more information to consumers. Greater scrutiny and increased transparency will have an impact on the regulator and as well as industry.

In the context of a rapidly ageing population and the growing importance of generics, which role does self medication play today in Australia?

The distinction between generics and innovator brands is probably more relevant in the prescription medicines arena. Of course for brand owners like GSK or Johnson & Johnson generic house brands have an impact on them. The brand owners that invest in education and information provision find it challenging to compete on price with house brands. who are not supported by these programs

If we were to come back four years from now for the next edition of our report, where will you have taken ASMI and what will ASMI have achieved for the industry?

Hopefully the TGA’s Blueprint for Reform would have been implemented successfully over the next 3 – 4 years. If plans remain on track we will be close to the establishment of the joint Australia New Zealand Therapeutic Products agency which will result in a single market..

I hope that in four years time we can say that advertizing for all S3 products is allowed. We are working on an alternative advertising model which will permit the promotion of all Pharmacist Only (Schedule 3) medicines. That would be a major achievement for our industry. Under the proposed model the emphasis will be on creating consumer awareness about product rather than and the condition it is indicated for rather than promotion and it will reinforce the role of the pharmacist in the supply of the product.

We will have streamlined processes for the processing of product applications and companies will be able to plan commercial activities, like product launches with a much greater degree of certainty. The average turnaround time for product evaluations used to be 72 days, and while I do not believe that we will return to those terms because applications are more complex, I do believe that we can shorten the time frames and, most importantly, get a degree of certainty and predictability. For pharmaceutical manufacturers it is crucial to know that they will be able to launch a product a more or less set term after applying, even if it takes two years. At the moment this certainty is lacking.

We’ll continue to pursue our primary strategic objective, i.e. the adoption of self care as part of an Australian National Health Policy. We’ll be building the evidence base to support our self care initiatives – and the management of minor ailments by pharmacist and we’ll be developing an Australian switch agenda to increase access to OTC and complementary medicines.

What is your final message for the readers of Pharmaceutical Executive?

The Australian non-prescription medicines market is exciting and dynamic and offers huge opportunities. Yes, there are challenges, but we are working on those to make a difference. For ASMI and its members the mission is to build on its credibility and track record and to be recognized as having a legitimate and important role to play in healthcare delivery in Australia.