Juliet Seifert , Australian Self Medication Industry(ASMI)
Release Date: 2008-07-08
Would you please introduce ASMI to Pharmaceutical Executive readers?The Australian Self Medication Industry has existed since 1974, and was previously known as the Proprietary Association, and then the Proprietary Medicines Association, finally becoming ASMI to indicate a change of direction and make clear what it stood for. This last change also followed the world organization which had changed its name from World Federation of Proprietary Medicines Manufacturers to the World Self Medication Industry. ASMI represents the vast majority of manufacturing companies in the Australian market by volume comprising over 85% of the OTC arena, and also the complementary sector, including vitamin, mineral, and herbal products that make therapeutic claims, and representing the interests of both of those areas equitably. In the Australian system, both sectors are classified as medicines. ASMI promotes a regulatory regime that maintains a level playing field, avoiding a different system for what in other countries is a food supplement market.
What have been the main milestones in Australian market over the Association’s history?
The main milestone was recognition of the OTC medicines as a separate sector, bearing in mind that when I joined the Association in 1989, there was for the first time a national legislative approach for OTC medications through the Therapeutic Goods Act and Regulations, implemented in 1990/91. Until that time, all controls in Australia had been at the point of importation rather than manufacture, and there was only one state, Victoria, that actually had a registration scheme at point of market entry. The principles of this scheme were examined and built upon to form a national scheme, and the centerpiece of that is a register of therapeutic goods, which comprises every medicine – whether prescription, non-prescription, or complementary – and every device which has been granted market entry. This was the beginning of negotiating a system of regulatory controls specific to OTCs, so they didn’t automatically inherit what was intended for and appropriate to the prescription market, and creating a differentiation on the basis of risk and benefit, and getting that balance reflected in policy and regulation. Part of this involved allowing the industry to assume greater degrees of regulatory responsibility by allowing it to self-regulate, with the government devolving approval of all advertising in mainstream media to industry. It’s now a co-regulated system in that there’s an advertising code underpinned in the law, and formally delegated approval of medicines advertising, which has been in place since the early 1990s.
What are some of the biggest issues facing the industry in Australia?
Australia, like many countries, is looking at how to get the greatest value out of every healthcare dollar. In its current focus on prevention, the government has chosen the three key areas of alcohol, smoking, and obesity on which to focus first. OTC fits in strongly with two of those three, with smoking cessation programs in particular, where it’s important to make people aware there is a range of products for different categories of smokers, and that people rarely succeed the first time around, regardless of type and product selection. These products also have behavioural support programs that help success over time. Industry, in this instance, should partner with government with whatever they’re planning to do to ensure a coherent strategy. If the government wants to partner, to consider appropriate incentives and goals, we should be alongside them. The government’s goal is to deliver a public health message: why is giving up smoking important for your health? Here are some facts and figures. The industry’s role is to say: you are not all alike in your addiction to smoking, there are different products available, and you need to talk to an appropriate healthcare professional about which one suits you best.
How will PBS reforms, a key issue across the pharmaceutical sector, affect the OTC segment?
In a direct sense there are no immediate effects, but if this government is setting up mechanisms to look seriously at prevention, at some point they must consider a range of issues, including looking at what GPs are spending their time on now, and how this time could be better used. It will be important that people become better informed about things they can do themselves, thereby freeing up time GPs could spend treating more serious and chronic diseases, and be more diagnosis and prevention focused. There will be many areas where an initial consult will lead to a GP saying “this is what you need to do for yourself, and come back in six months to reassess, or talk with your pharmacist or have it monitored by another healthcare professional over time.” There are many areas where this might apply. In Australia there is a high incidence of cardiovascular disease, so the potential for early identification of predisposition and family history is there. There are roles for both p0harmacists and GPs, and there is room for products in this space that can make a difference.
Where will the push come from? If GPs decided on their end to act, would the industry be adequately organized to support that kind of approach? Or does the industry need to do more from its end for the GPs to have enough confidence to take the actions you describe?
It needs to come from both sides. The difficulty in this size of market is that if you look at hard numbers in certain categories, there are a range of other issues that arise, for example with IP protection. The current system does not necessarily afford companies incentive to switch, because the size of the target market in that particular disease population could well be economically unviable. Australia needs reforms to ensure that when a product switches, the company that does the initial investment gets timely market benefit. Switches will not happen unless there are market exclusivity protections. At the end of the day Australia is a small market, and broken down by disease state, viability depends on such measures. ASMI works across the departments of health and industry ensuring they each understand what is involved. Progress happens over time, but the right incentives and pressure points must be there.
Is there some reluctance to relinquish GP power to other professionals?
There are always turf issues amongst healthcare professionals in every country, and Australia is no different.
In other pharmaceutical segments, traditional manufacturing is in decline, with multinationals preferring to offshore production in low-cost or incentive-rich countries. What’s the case for the self-medication industry?
It’s pretty much the same. It’s a function of Australia’s policies and incentives for local manufacture, as well as global headquarters considering where they want to invest in R&D. Historically, for the prescription industry Australia was a good place to invest in R&D because there were government support programs, which came about in part from having a good track record in clinical trials, and good partnerships between industry, academic institutions and research institutions. There was quite a
lot going on and a lot of opportunity. A lot of that still exists, but in terms of policy future commitment to maintaining past strength, that remains to be seen.
In the OTC segment, which companies would you point to as the biggest success stories?
Every one of our members is a success story, across a range of categories. Boots previously, now Reckitt Benckiser with Nurofen, the cough-cold and hayfever categories, and many others; there are good news stories across them all. Smoking cessation products also stand out. A walk through Australian pharmacies quickly shows the range of successful products.
What is your vision for the future of the industry, and the work ASMI will be doing in terms of advocacy and its expected outcomes?
ASMI wants government to follow through on its pre-election statements on future of self care, and prevention. The organization wants to see this built in to policy so that it flows through to regulatory policy, is also as necessary reflected in industry and treasury approaches, because there needs to be a cohesive approach – it can’t be in one area without looking at what has to happen in other portfolios. For example, if you want to encourage people to do more about their own health, it’s important to look at where the most effective areas are going to be. If you ask people to fund out self care out of their own pocket, it’s necessary to have different forms of incentives, such as tax incentives through deductibility, or third party payers. In Australia, some insurance companies are funding some prevention but it’s somewhat ad-hoc; but it’s not a cohesive policy implementation. Australia needs a comprehensive plan, and to create a system where products are better understood, used more broadly, and consumers are encouraged to learn more about them and access them in an affordable way. This will take a mix of economic approaches.
Where are the biggest pressure points in encouraging consumers to self-medicate and focus on prevention? What will it take for them to increase acceptance?
The answer is in education. I personally believe you need to start in schools. Behaviour change is one of the things the Jesuits taught us years ago that is difficult to achieve after the age of six. It’s different for older generations to change dietary, smoking, or alcohol habits. You can only get marginal improvements, and set percentage reduction targets. The key is to focus on young families and young children in the next generation. ASMI has partnered with an organization called Life Education, starting to get a message across about healthy living and lifestile by dealing with issues around smoking, alcohol, and medicines. They get the message across that medicines are good but do have risks, and the meaning of safe use. Life Education takes mobile vans with professional teachers around to all primary schools, and it’s those sorts of programs that companies and individuals have to work with to spread the message. Government has to be willing to partner with and be more trustfing of industry in how messages can be communicated. There must be a partnership approach between industry and government because neither can achieve their objectives alone. Government can go out and spend millions of dollars on quit smoking campaigns, but with the effective and co-ordinated support of companies to reinforce the message, they will be able to achieve much more sustaintable success in the long term.
What is your final message to Pharmaceutical Executive readers?
There is huge opportunity to help people understand what more they can do for themselves about preventing serious disease and dealing with chronic disease, and moving beyond just the historic milieu of OTC products which was dealing with symptomatic release of minor ailments. Worldwide, most organizations are trying to move with this distinction in mind. Healthcare professionals will start playing different roles: pharmacists in the future will be getting much more involved in counselling in key areas. There is no reason why pharmacists could not handle many of the areas of ongoing monitoring, including compliance, currently covered by GPs. Government will recognize this as worthwhile and as an important additional roles. Australia has been PBS focused, but its more than about PBS, but rather the role everyone’s playing. Australia needs a much more holistic approach.
Advice, counselling, ways of monitoring with appropriate checks and balances are needed, properly designed processes, data appropriately captured, while dealing with the privacy issues that naturally arise, will result in a better scheme to deal with prevention – but it’s going to take a lot of careful thinking through ad structuring.
| Company: | Australian Self Medication Industry(ASMI) |
| Position: | Executive Director |
| Country: | 澳大利亚 |