Laurie Ferguson (Reid, Australian Labor Party, Shadow Minister for Consumer Affairs) Share this | Link to this | Hansard source

The opposition supports the Therapeutic Goods Amendment Bill (No. 3) 2006. It is essentially designed to streamline the application-making process for medicines, blood products and tissue. The e-business portal will enable manufacturing applicants to monitor the passage of their applications and to make amendments as the need arises. Since taking over as the shadow minister with responsibility for the TGA, I have embarked on an extensive process of meeting key TGA stakeholders. These include consumer and industry groups. To date I have received significant feedback which has reiterated the perception of the competence of the TGA. Whilst it has its critics, the TGA commands widespread respect.

The Medical Industry Association of Australia have, over the past few months, made a concerted effort to keep me fully informed of the key issues with which they have been dealing over the past few years. Given, as I say, that this bill is non-controversial and there is agreement to it from the opposition, I intend to make some broader comments. I recently had the pleasure of touring key medical devices manufacturing operations and distributors in my own and neighbouring electorates. During our meetings, the MIAA and their members raised numerous issues with regard to the industry and the TGA. According to the MIAA, the industry supported the 2002 revision of the Therapeutic Goods Act and regulations to provide a harmonised regulatory model for medical devices and in vitro diagnostics. Industry support was then based on three important factors: (1) the incorporation of a risk based approach to regulation; (2) harmonisation with the regulatory systems of Australia’s manufacturing suppliers, in terms of both the content of the legislation and the TGA’s interpretation and administration of the regulation; and (3) cost-effectiveness.

The medical devices industry’s support for the proposals was based on an expectation that harmonisation of the system would reduce regulatory duplication and shorten the approval time to allow medical devices onto the Australian market. To date, the MIAA are reporting to me that their expectations are unmet. According to them:

Australian manufacturers and importers face considerable difficulty and costs in moving to the new model. Transition of products has proved to be slow and there is a real risk of products (manufactured locally or imported) not being available to consumers in Australia.

Industry had envisaged the TGA act would be consistent with the Australian government’s public commitment to the work of the Global Harmonisation Task Force, the GHTF. Their objectives focus on providing a forum for national regulatory authorities and industry representatives from the European Union, the United States of America, Japan, Canada and Australia to promote international convergence in regulatory requirements and practice and, in particular, to promote the safety, effectiveness, performance and quality of medical devices; to encourage technological innovation; and to foster international trade. It would also serve as an information exchange forum through which countries with medical devices regulatory systems under development could benefit from the experience of those with established systems. The MIAA have publicly stated:

... the majority of current problems for industry result from the regulations’ deviation from the European framework with which they were originally intended to be harmonized.  The resulting extra work for many Australian sponsors and their suppliers on top of regulatory work performed and approved elsewhere in the world, means the Australian system is currently duplicative, difficult and expensive.  Even though the new regulatory system is in its early days, MIAA believes that the signs are already becoming obvious that it will negatively impact the growth of the Australian industry and ultimately affect consumer access to state-of-the-art technology.

From an industry perspective, the majority of the current problems arise as a result of losing sight of the European framework with which they were originally supposedly to be harmonised. Whilst lodging manufacturing applications may be a minor part of the delay, all the same it will aid in the process of creating greater efficiencies, especially given that the industry is looking to move more than 10,000 items into the new regulatory regime before the October 2007 deadline. Obviously, that is a mammoth task—10,000 items will be basically moved over and reauthorised, and the clock is certainly ticking.

I turn to the complementary health sector. I recently had the opportunity to visit the Symbion vitamins manufacturing plant in Virginia, Brisbane. This is one of the country’s leading manufacturers of complementary medicines, also known as neutraceuticals. Again, I take this opportunity to highlight some of the key issues which are currently affecting this aspect of the industry and their dealings with the TGA.

Treating this field as a type of drug is probably the right approach, so long as the nature of the products and the supply chain is properly allowed for. Raw material manufacturers are not subject to good manufacturing processes. This creates difficulties for the industry, as the companies involved in Australia are essentially unable to control the supply chain and guarantee product. Australian industry is relatively small, so there are limits to what we can expect overseas raw material manufacturers to undertake for the Australian companies. They are generally controlled by large US manufacturers. Australian companies report that the size of the Australian market means that they are unable to gain priority. Australian requirements and expectations tend to be a low priority for these companies.

Natural variations in raw materials are to be expected, so pharmaceutical type tolerances are not achievable. To this end, greater margins for deviation are essentially to be allowed for. The margins are much tighter, so compliance costs must be reasonable. This is especially important given that the public health risk is generally much lower. A greater risk management approach by the TGA is sought by the manufacturers. Compliance should be linked to consumer risk.

The TGA are more used to the nature of the pharmaceutical industry and prefer the greater certainties, and they tend to interpret the guidelines along pharmaceutical lines. Whilst industry recognises the need for institutionalising the highest possible standards, there is, nevertheless, a perception that these standards ought not necessarily to be those of the pharmaceutical industry. Enforcement of regulation lacks transparency and accountability in this field and is therefore often inconsistent—for example, between big and small or between Australia and overseas. Again, manufacturers require a universal standard applied to all manufacturers, regardless of the size of the operations. They also require greater transparency and consultation by the TGA. They take the view that the Pan calamity has created a very uneven relationship with the regulator, and yet the reality is that industry has moved on and now operates under a totally revised regime.

Compliance costs are probably amongst the highest in the world. I ask: is this based on evidence of any specific problems? The process to debate audit issues does not seem to be in place or is ineffective, as communication is normally restricted to the lead auditor. Contacting auditors and seeking advice on and interpretation of issues is very difficult, and the time taken for resolution is often commercially damaging. Audits are becoming longer and more in-depth. Why is this set in stone for companies with a proven track record, as against those which are perceived to have more risk, either domestic or overseas owned?

The issues raised above are contributing to a situation where domestic manufacturing is being replaced by overseas options, especially from India and China, where manufacturing is cheaper and audits are more difficult to conduct. And yet it is not likely that the standards in India and China are higher than or equivalent to the standards that we have here in Australia. Certainly, it is much more difficult to audit a plant in China or India, for that matter, than in Australia. Likewise, there is little evidence to suggest that there are any unannounced audits in places such as these countries.

I turn to concerns of consumer groups in respect of the TGA and the broad field of pharmaceuticals. In a submission to the ACCC the Australian Consumers Association argued that the objective of the regulation of pharmaceutical marketing should be to achieve a balance between the interests of pharmaceutical companies in promoting their products, the need for consumers to receive accurate and comprehensive information about medicines, and minimising the risk of overprescription or incorrect prescription. Consumer groups have expressed concern about the manner in which pharmaceutical companies target both consumers and doctors in their marketing practices. Some pharmaceutical companies have circumvented the prohibition of direct consumer advertising by a number of means, and these have been internationally exposed in recent months. Advertising is masqueraded as educational campaigning. They place stories in the media that are presented as medical breakthroughs. They sponsor high-profile events. They subsidise academics to provide favourable expert opinion, and they sponsor prizes for journalism awards.

Whilst the opposition supports the provisions of self-regulation in the pharmaceutical industry, it is also a reality that much of the abuse outlined above arises from a seemingly lax attitude to enforcement by the self-regulatory body. An example of this is the self-regulatory code sanctions, which are inadequate as they clearly pose very little deterrence to repeat offenders. The ACA argue that it is a fundamental requirement of any successful code that there be meaningful sanctions if the code is breached. Most fines imposed by the code committee are under $25,000 and only one was more than $100,000. I think we know how those sorts of penalties would be regarded in a very highly capitalised industry such as pharmaceuticals.

Abuses of the current self-regulatory system are detrimental to consumers. Advertising inflates the prevalence of certain conditions and encourages consumers to take medication that they may not need. Increased demand for new products occurs when older versions with the same efficacy are available, and that inflates the cost to the Pharmaceutical Benefits Scheme. The limitations of the self-regulatory regime extend much further than advertising. Advertising can take the form of insidious incentives, as revealed two weeks ago in the press, which point to a culture of handouts and expensive functions for physicians, fully paid for by pharmaceutical companies.

Roche Pharmaceuticals were recently in the news for providing cancer specialists with a $200-a-head meal at the Opera House Bennelong restaurant. Roche argue that this dinner was simple, modest and appropriate given that it followed an education conference the company had organised and sponsored. For what purpose? For their own purposes.

The Australian Medical Association raced to the defence of its members’ right to attend such functions. It even went so far as to argue that it is part of the process of ‘oiling the wheels’. This was clearly inconsistent with the standards set by the Medicines Australia code—that is, by the pharmaceutical companies themselves—which suggests that hospitality be simple, modest and reasonable. Whilst the AMA is unable to identify fault in the manner in which its members are wooed by industry, the ACCC has taken a more critical view by reauthorising the code with an added emphasis on monitoring and publishing details of hospitality received by AMA members. Whilst the views of the AMA are held in good faith, there is mounting evidence contradicting its sincerity and sense. The online journal New Matilda last week carried an article by Dr Ken Harvey, who stated:

A large amount of research contradicts the view that no patient harm comes from such interactions between the medical profession and the pharmaceutical industry. Research shows that industry-doctor interaction correlates with doctors’ preferences for new products that hold no demonstrated advantage over existing ones, decreased prescribing of more cost-effective generic drugs and a rise in both and irrational and incautious prescribing.

In conclusion, I have canvassed a number of other facets connected with the TGA and broader pharmaceutical industry. The bill is supported by the opposition. It is a step towards ensuring swiftness of operation, and we endorse the bill.

Luke Hartsuyker (Cowper, National Party) Share this | Link to this | Hansard source

I welcome the measures contained in the Therapeutic Goods Amendment Bill (No. 3) 2006. It will allow the Therapeutic Goods Administration to conduct a modernisation of its procedures with regard to the issue of licences and to make a further response to the report of the National Audit Office in 2004. I would like to take the opportunity to dwell on the current pressures on the health service—in particular the Pharmaceutical Benefits Scheme, the demand for alternative or complementary medicines and the response to these pressures in regional areas.

Currently, under section 37(1) of the Therapeutic Goods Act 1989, manufacturers of medicines, blood and tissues have to apply in writing for the relevant licences. The passage of this bill will enable them to lodge such applications electronically. Manufacturers will be able to track easily the progress of their applications and to make necessary amendments. It should make the process rather more attractive to manufacturers and ease the passage of new products onto the market. No information additional to that required for the existing application process will be required, so there is no extra bureaucratic burden on the manufacturer. The measure will also enable the TGA to continue to address criticisms made by the Audit Office of its data management, documentation and record keeping.

I mentioned pressure on the health service. One pressure is the public’s demand for medicines in general. We are encouraged to become more health conscious, to become more aware of health risks and to take early intervention and preventative action. That is fine as far as it goes. It is clearly better for the individual and for the finances of the health service for an ailment to be dealt with quickly and cheaply at an early stage than to be left until a lengthy, expensive treatment or surgery is required. This increased level of consciousness has led to a greater knowledge of what medicines are available and a greater demand for those medicines provided under the Pharmaceutical Benefits Scheme, or PBS. This is particularly true of expensive drugs that have proved far more effective than their competitors for a limited number of patients. However, with cost pressures, it is often hard to explain to a sufferer of, for example Crohn’s disease, why they may have to pay thousands of dollars for a drug treatment which provides them with great relief and which may remove the need for complex surgical intervention at a later date. I hope we will be able to provide improved pharmaceutical support for Crohn’s sufferers at some stage in the near future.

But I acknowledge this is both a difficult area, in assessing the efficacy of drugs, and a political area. How do we administer a program such as the PBS for greatest benefit? It is also true that many drugs coming onto the market are expensive and may be suitable for a wide range of patients. This means great cost pressure, which needs to be managed carefully if we are going to ensure that our health budget delivers the maximum benefits. The current annual cost of the PBS is $6.2 billion. I would imagine there are a few who would argue that we should cap this cost and abandon our support for medicines. But I would also imagine there are a few who would argue that this process needs to be very efficiently managed so that we reduce costs wherever we can. There is a role for the public to play in this.

I am not convinced that the increasing level of consciousness of the need for personal health has resulted in a sufficient commitment to greater personal responsibility. Prevention, after all, is better than cure. Prevention lies, in many cases, in our own hands. We all know that managing our diet, avoiding cigarettes and reducing our alcohol intake can have substantial personal benefits. However, sadly, in many cases people still overindulge and fail to manage adequately their own personal health.

Let us consider the message on diet for a moment; it is clearly not getting through. Australia is one of the fattest developed nations. The percentage of Australian adults who are overweight or obese has doubled in the last two decades—that is, 67 per cent of men aged 25 to 64 are overweight or obese, and the equivalent figure for women is 52 per cent. It is a huge problem. More worryingly, 20 to 25 per cent of Australian children between five and 17 are overweight or obese. That is double the prevalence recorded in 1986. These children and adults are at greater risk of diabetes, heart disease, stroke and some forms of cancer. The cost of obesity is estimated to be some $1.2 billion a year. If we could eliminate that, we could spend that $1.2 billion in other areas. I welcome the setting up of the National Obesity Taskforce but, unless we accept personal responsibility for our own health, obesity may end up as an absolute epidemic. I know that not all obesity is self-induced, but I think it is fair to say that much of that $1.2 billion could be saved. It is one-fifth of the current annual cost of the PBS.

There is another perhaps more easily attainable form of saving that will require if not personal responsibility then public acceptance, and that is the use of generic drugs. Many people are reluctant to accept the cheaper generic versions of a drug, particularly if they have been used to receiving the originally patented version for some length of time. As more patents expire, there will be more generics available. I believe we have to work hard to overcome this reluctance to use generic drugs so that the savings made in the area of generics can be put into new, innovative drugs that will potentially provide huge gains to people in our country.

I noted in Wednesday’s Sydney Morning Herald a report that the Indian pharmaceutical company Ranbaxy has secured listing of four of its low-cost generics on the PBS. Ranbaxy is the first Indian company to have its drugs listed, and the move is expected to generate increased price competition. There are clearly opportunities here not just to control the cost of the PBS but also to possibly help meet the cost of providing some of those innovative drugs I spoke of earlier. I should say that the cost is by no means the only criteria for listing on the PBS, but it would be unrealistic to operate on the basis that the PBS could be isolated from all cost pressures. I welcome the comments by the Minister for Health and Ageing, Mr Abbott, that savings from the introduction of generics can create headroom for spending on the newest, more expensive drugs. There are benefits here for patients, and we should grasp the opportunity.

I should remind members that the government have increased health spending in the area of aged care. We have spent in total on health some $48 billion, $20 billion more than in 1996-97. We are currently increasing the availability of new drugs on the PBS by providing more than $750 million for new treatments for colon cancer, breast cancer, heart failure and high blood cholesterol. More than 350,000 Australians are expected to benefit from these drugs.

It is worth noting that, while many express the view that the PBS should provide more and that they should pay less, the expert committee report Complementary medicines in the Australian health system, published in 2003, estimated that the annual turnover of complementary medicines was some $800 million. The total market in this area, including purchases made from overseas companies, is likely to be far higher than that. The same researchers reported that 52.1 per cent of the population surveyed had used at least one non-physician-prescribed alternative medicine, with an additional 20 per cent of Australian complementary medicines output being exported. This is clearly an area of medicine that holds a strong attraction for many people, who are prepared to spend a great deal of their own money. Without wishing to comment on the efficacy of the products, we need to ensure that the products of this apparently profitable industry are safe. It is right and proper that the TGA is active in this area. Insofar as this market represents an economic opportunity and provides choices the consumer clearly wants, the measure we are discussing today will make it easier for manufacturers to bring new products onto the market.

There are those who say that we should remove all cost restraints from the PBS and that, if a drug is licensed by the TGA and prescribed by a doctor, it should be available. There are many, including the sufferer of Crohn’s disease whom I mentioned earlier, who would no doubt welcome an expansion of the drugs covered by the PBS. We do have to have cost control, but I certainly would welcome an extension of therapeutic assistance to Crohn’s sufferers in the near future. However, it is easy to forget that budgets are limited. It is easy to forget that extra money spent on the PBS might mean less money to subsidise bulk-billing, which covers almost seven out of 10 consultations in my electorate. It might also be easy to divert funds from one area of the health budget, such as the Medicare safety net. That is an example of the difficult choices in health that need to be made and the importance of ensuring that we tightly monitor the costs of the PBS to derive maximum benefit for the community at an affordable cost to the government. If we were to overspend in one area of health, it might mean that worthwhile projects might not go ahead. Some new, groundbreaking areas in the health system may be retarded by a failure to appropriately control costs in other areas.

I would like to dwell for a moment on an important project, the Rural Palliative Care Program. It is currently supporting a number of pilot projects—one of which is in my electorate—and provides stakeholders with improved access to quality palliative care in a regional or rural setting. I think that is vitally important. I am pleased to have such a pilot in my electorate. Earlier this year, I was able to announce that Baringa Private Hospital in Coffs Harbour was to receive nearly half a million dollars to set up a palliative care service, increasing the number of palliative care beds and providing additional clinical and IT equipment. These measures will improve the quality of life of patients who have serious or life-threatening diseases, treating as soon as possible the symptoms of the disease and the side-effects of treatment and providing psychological, social and spiritual assistance as may be required during the time that that person and their family are dealing with that illness.

These new and innovative programs are the sorts of programs that can go ahead because we focused in the area of health very much on economic efficiency and economic effectiveness, which provided the budget to do these more innovative programs. The Baringa hospital project will ease the pressure on existing facilities and so make those resources available to other patients, as well as support the sufferers and their families. The funding comes from the Rural Health Strategy, which is providing some $830 million over four years for health and aged care services and workforce measures.

In June 2005, the Minister for Health and Ageing came to Coffs Harbour to open the $3 million Rural Clinical School, which is now training medical students through the University of New South Wales but substantially in rural and regional areas. The strategy behind the Rural Clinical School is that if we train our doctors in a regional setting they are more likely to practise there. The rural workforce is a major issue which needs to be addressed in rural and regional areas. It is one the government is very focused on. It is one that we are achieving in. It is one that the Rural Clinical School plays a major part in developing.

Last month, Minister Abbott was in Coffs Harbour to open a $1.2 million nursing laboratory, which included two four-bed simulated wards. The training of nurses in a regional area is basically done on the same principle as the training of our doctors—that is, if we train our nurses in a regional setting they are more likely to stay there. I certainly welcome the commitment by the government, which was substantial funding of some $850,000 under the Commonwealth Grants Scheme, to assist in the construction of this $1.2 million facility. This impressive project complements the government’s investment in 164 extra nursing places, which I announced some two years ago. These measures are all designed to address the issue of rural and regional workplace shortages and, as I said, train those health professionals in the area where we would like them to practise. Good health care is about planning. Good health care is about spending money efficiently. But, more than anything else, good health care is about the skills and empathy of the people working in our hospitals and clinics.

In conclusion, I would like to mention five people who received certificates of appreciation for a lifetime commitment to health when Minister Abbott visited Coffs Harbour last month. Doctors Jerry Power and Michael Ridley and nurses Helen Jones, Gay Bowen and Carol Brewster received certificates from the minister to recognise a lifetime contribution to the health system. It is professionals like them, who not only contribute their skills but also repay the investment in their training many times over, who are the mainstay of our health service. Whilst often we spend much time in the area of health arguing over the issue of money, I think there is one thing that is inarguable, and that is the commitment and dedication of the many health professionals who are the backbone of our system and who make it work year in, year out.

Michael Hatton (Blaxland, Australian Labor Party) Share this | Link to this | Hansard source

We have had a broad-ranging debate so far on the Therapeutic Goods Amendment Bill (No. 3) 2006, based on what is fundamentally a very minor change. The amendment to the Therapeutic Goods Act in this bill allows those manufacturers of medicines, blood and tissues to make an application for a manufacturing licence electronically using the Therapeutic Goods Administration’s e-business system. That brings it into line not only with a number of other government departments which are using e-business but also with changes that have already occurred.

I want to look at a couple of aspects of this. One is the broad question of e-business and the transition from the old paper forms across government to the new electronic model. The other is the effectiveness within the department itself and the fact that the manner in which the particular matters were carried out by the department has been heavily criticised. In the background paper put together by the Parliamentary Library, there is a section—which I will deal with a bit later—with regard to an audit report done by the Australian National Audit Office on the manner in which the department had been conducting itself.

This is a tiny example of a change, but the implications are very great. The old system—one could say almost a 19th century approach but a very useful one, people just simply being able to write—specifically stated this, and that is why we actually require a specific change. That is section 37(1) of the Therapeutic Goods Act 1989. It says:

(1)

An application for a licence must:

(a)

be made in writing in accordance with a form approved by the Secretary ...

You can find that in just about any government documentation you can imagine. But specifically under the Therapeutic Goods Act in order to get the licence it had to be in writing and it had to be on the right form. The change here is to say that it does not have to be in writing on a bit of paper. It can be in text form and certified text form as part of the process being introduced in e-business, and that is as good as you will get. This would be of no surprise to the Japanese, who worked it out a very long time ago. The original fax machines were developed in the 19th century and used to transport a paper written piece of work. The first fax machines were not developed in Japan but the Japanese took them up more than anyone else.

Cameron Thompson (Blair, Liberal Party) Share this | Link to this | Hansard source

Mr Cameron Thompson interjecting

Michael Hatton (Blaxland, Australian Labor Party) Share this | Link to this | Hansard source

For the benefit of the member for Blair, the first fax machines in the world were developed in the late 1870s. They did not become a world standard. It took us about another 100 years before they became world standard very simply because there was a particular way of going about it. If you go back to about 1986, when I attempted to convince Voca Communications that it would be really smart to provide scanners to electorate offices by simply upping the dpi from 200 to 300 in the fax machines that they were providing us—it was possible to make a technological leap—Voca were able to supply the Department of Finance and Administration with fax machines at the time simply because there were worldwide standards.

In the 1870s the first fax machines were put into place. The problem was that you had to have one fax machine from one manufacturer at one end and another fax machine at the other end that was exactly the same. But it was in the late 19th century that the first images passed from one end of the globe to the other by fax. The Japanese realised that you did not have to have a piece of paper to put an application in that had to be handed mechanically to someone. Because of the nature of the currency system that they have, you could write what you wanted and then send it electronically by fax machine, because it was a facsimile.

In this legislation finally we get a realisation that it does not have to be on a bit of paper. You can send it. You can write it and then send it by fax. Legally you can do that in almost any transaction or contract in Australia and that is allowed. But we go a bit further, and in this legislation it says not just sending it by fax but sending a representation of what you originally did on paper. You can lodge it on an e-business basis. To get from there to here over time takes quite a great deal. People do this in halting steps. The government has been right, as have other governments around the world, that it is possible to do things better and to be assured that you can improve, in this case, licensing for medicines, blood products and tissue by making this change to facilitate it. If you set up your system in the right way you can be assured that people from outside are not participating in this process, as long as you get the right protocols, it is signed off and it is not people who are trying to subvert the system. You can do it in a more efficient way.

If you look at the broader question of how we move goods around and the controls there are in Quarantine, Customs and so on, there has been a slow and deliberate process of changing over to these kinds of mechanisms. So people involved in shipping, companies that are heavily involved in goods forwarding and so on realised many years ago that it was a hell of a lot smarter to do it this way than it was to use the old paper forms. Even though we have a GST that is still fundamentally designed the same way as the GST was in the 1960s—and it was introduced in Europe and elsewhere as a paper based trail—you can in fact do all of that electronically. It is a case of: if you can do it, why wouldn’t you? In terms of the operations of the act, this simple amendment:

... will remove the requirement for an application for a manufacturing licence to be made in writing, and instead permit the electronic lodgement of an application. The amendments will make section 37 consistent with other provisions in the Act.

Departments have all sorts of problems. Often they have problems with their ministers, with the people who work for them and with their systems. When there is a proposal to change the mode of work, there can be resistance from people within the department or simply due to the amount of time and effort it takes to make the changes. But it can be that sometimes there is a big impetus to get these things under way.

If you look at the work that the library has done on the Therapeutic Goods Amendment Bill (No. 3) 2006, you can see that in the relevant department there was a bit of both here. There was some internal movement. They decided to bring in what was called a ‘manufacturer information system’ to provide for more efficient processing of the different types of applications made to the various areas of the TGA. The purpose of that, they outlined, was to eliminate paper forms and to allow electronic application for manufacturing licences for medicinal natural products, certification by audit of overseas medicines manufacturers, variations to each of the above and clearance certification of overseas medicines and manufacturers by assessment of GMP evidence provided by an overseas regulatory body.

That process is fairly broad ranging. It looks like a simple thing here to say that it does not have to be on a bit of paper—even a bit of paper that can be lodged by fax—and that you can go to an electronic system. Anyone who has tried to introduce a system like this knows that it is not as simple as it might seem. It involves a great deal of reorganisation of the department. People who have done similar things at universities in trying to deal with new personnel systems and so on know that what used to be simple becomes more complex, particularly when you are dealing with a whole range of different manufacturers. Also, you have to educate people in how to use these systems, particularly if you have people using them overseas, but the benefits are clear and significant.

If you can get everybody used to the new system, not only can you be quicker but you can be smarter. You can also track what has been done in a much more efficient way than previously. An example of what happens can be seen in this parliament with its move to using less paper. We still push out volumes of the stuff and overutilise it. We have photocopiers all over the place, including in our offices. The great idea—and this may even be taken as part of it—was that we would go to a paperless office. But people think we are using more paper than we did in the past. However, there is some light ahead—and the Deputy Speaker would agree with me on this—in terms of the amount of paper that is being pushed out because, at the practical level, departments are pushing to do this sort of thing and are making those sorts of changes. There is also some light ahead because of the capacity of current computers to churn through images and because we have a bigger and broader storage capacity than we had before. We have better scanners. We are trialling a program in the electorate offices that uses networked photocopiers, which we hope will work.

We should be able to use those photocopiers as scanners, which I tried to get Voca to do in 1986. If they were used with Nuance software—which has changed its name to PaperPort—which is almost the industry standard, you could do away with most of the paperwork. Not only could you image your material and store it but you could use optical character recognition, which is now of a fairly high standard. You could make fully searchable electronic documents not only in electorate offices but also in Parliament House. The Parliamentary Library has done that.

If you want to know about the therapeutic goods amendment bill 2003, it is available in electronic form. The Bills Digest is also available in that form from the library. Any material associated with this, including press releases in which people in the industry have made comment on this or any other bill, is imaged and made into a searchable, portable document format. That means you can have a greater control over what is happening, and for people in therapeutic goods it means you can have efficiencies in running the department and dealing with the mass of paper documentation because, having made it into an electronic business system, it is searchable and more available to you. The Bills Digest sums up the benefits in this way:

The benefits associated with the electronic lodgement of manufacturing licence applications were highlighted in the second reading speech of the Bill; in particular, that the amendments will allow manufacturer’s to monitor progress with their licence applications and electronically submit requests for amendments to their licences.

I note that, even though this came out of the library, they were not able to use an apostrophe in the way that they should have. It is in fact not ‘manufacturer’s’ but the plural. One day we might march through.

The Australian National Audit Office in October 2004 brought down their report Regulation of non-prescription medicinal products. They were concerned about the whole process that had been undertaken under the Therapeutic Goods Act. The Bills Digest reads:

The audit report was critical of the information management systems and processes employed by the TGA, including its data management, documentation and recordkeeping procedures, and recommended that these systems be improved.

It is argued that, on this change we are giving legislative effect to, the message already got through to the Therapeutic Goods Administration and they brought in this system because of the investigation that the audit office had undertaken. So they have incorporated that. In the Department of Health and Ageing’s response to the audit they argued that many of the issues raised by the ANAO were being addressed and that they planned activities to address all the audit recommendations, but none had been fully implemented at that time. The challenges to a department in trying to deal with a world that is changing and with seemingly simple changes of this nature are fairly big, particularly where you are not just dealing with medicines. We have seen recent major changes in the government’s introduction of new regulations and new approaches to medicines that have gone off the protected patented areas. We have gone into generics with a major piece of legislation I spoke about in this chamber some time ago.

Trying to facilitate—for both directly Australian owned and offshore multinationals in Australia, such as Pfizer and so on—the licensing of those products and streamlining them will be beneficial in terms of the major pharmaceutical area, but there are also the fundamental issues of blood, blood products, tissues and their trade within Australia and world wide. There has been a significant attempt by the Red Cross and the authorities that are still responsible for this in Australia to boost Australian participation in donating blood and to boost the attempt to make people understand that, if you are one of the one in 10 or so people who is going to do it, you should support it and give it as much of a run as you can.

The alternative, if Australians do not do it in the numbers they have done it in historically, is that we will end up with blood products and tissue products coming in from overseas. They will add to our current account problems. They will also add to the question of whether or not those products have been effectively dealt with in terms of disease control and so on. The responsible Australian authorities in this regard are not afraid to change the licensing system to go to an e-business system, but I think they would be grateful to those members who in the past have dealt with the issues of the collection of Australian blood, its storage, the challenges in public health issues associated with our control of this. They would also be grateful that people freely and voluntarily have decided to help others in the community, that we do not trade blood as a good as other countries do and that it is one of the foundation stones of the way we see ourselves. In that area I think the most important things are (1) keeping local control, (2) ensuring that the voluntarism innate in our system is maintained and (3) that people get the message that it is very important that they join in and try to ensure this is the case.

Broadly, this change has been a simple one legislatively, if not simple at the level of the organisation that has had to deal with it. It has made a response not only to the Australian National Audit Office but to pressures within the department itself to make those changes. But the story is that 10 years on from 1996, with a government that is all about auditing and benchmarking, you have to make some practical changes to give effect to the government’s e-business strategy. I applaud the fact that in this regard it has done that. The Bills Digest says at the end:

According to the government, the amendments proposed in the Bill are expected to facilitate the speedy submission of licence applications from manufacturers and the efficient handling of these applications by the TGA. The amendments address the audit report recommendations that the TGA improve the integration of its information management systems, and strengthen its documentation procedures.

The final sentence, however, raises an issue generally but it is one that I put directly to the responsible minister or parliamentary secretary in terms of dealing with this at the end of the debate. It says:

However, in light of the Deloitte’s report, Parliament may want to confirm that implementation of all the ANAO’s recommendations has materially progressed since June 2005.

So I would put that specific issue posed by the Parliamentary Library to the relevant minister, parliamentary secretary or whoever is dealing with this at the end. However slight this bill is in terms of the legislative change that is made, the actual application here goes to something broader and deeper. So you either front up and do what the ANAO say, wherever they are housed, or you only go part way to making the sorts of changes that can really make a dramatic and significant effect and haul Australia kicking and screaming into an electronically image based world—a world in which e-business is not only possible but certified by the government taking the lead in its implementations. It needs to ensure that not only in relation to the Therapeutic Goods Act and all that it entails but across all government departments the move towards e-business is facilitated and that the mechanical needs of computer capacity and imaging are available across all sites. I point out to those in the National Party and the Liberal Party who want to abolish my seat of Blaxland, arguing that regionally people have been affected badly, you can access an electorate office by fax or image. (Time expired)

Harry Jenkins (Scullin, Australian Labor Party) Share this | Link to this | Hansard source

I rise to speak to the Therapeutic Goods Amendment Bill (No. 3) 2006. This bill proposes amendments to Therapeutic Goods Act 1989. Basically, these amendments will allow for electronic lodgement by manufacturers and is therefore a fairly simple and non-contentious bill. But, Madam Deputy Speaker Bishop, knowing that you are a great champion for the parliament and the House, keeping the executive on their toes, I think it is apposite to mention that the matters in this bill arise out of an audit report. We see in this bill some application of the executive’s response to that audit report, but we are not quite clear whether there has been a full commitment to all the matters that have arisen as a result of the ANAO’s audit report on the Regulation of non-prescription medicinal Products by the TGA. Hopefully, in the summing up, if anybody is going to bother summing up on this very small debate, those matters might be addressed.

As an aside, I think that it is quite interesting that, on this very simple, small, non-contentious bill, the House through the Main Committee is allowed to have a full debate. We have mustered I think four or five people to debate on it, whereas down in the main chamber on something of much greater moment the debate is going to be curtailed.

Cameron Thompson (Blair, Liberal Party) Share this | Link to this | Hansard source

Mr Cameron Thompson interjecting

Harry Jenkins (Scullin, Australian Labor Party) Share this | Link to this | Hansard source

The honourable member for Blair is in the Main Committee chamber at the moment. He had his opportunity on the migration bill.

Cameron Thompson (Blair, Liberal Party) Share this | Link to this | Hansard source

Get back to the bill.

Mrs Bronwyn Bishop (Mackellar, Liberal Party) Share this | Link to this | Hansard source

Order! The member for Scullin has the call.

Harry Jenkins (Scullin, Australian Labor Party) Share this | Link to this | Hansard source

I will try to return to the bill. I was allowing myself to be provoked by the disorderly behaviour of others in the Main Committee, and I apologise. I thought that one should note the difference when it comes to these bills. To the officers of the department, the authority or whoever you are: I am not trying to belittle this bill; I am just making the comparison that sometimes we are allowed to have these full debates about minor matters whereas we have minor debates about the major matters. I think that is a little incongruous.

Others in this debate have illustrated—I think, because they have been assisted by the Bills Digestthe technicalities of the bill. I want to make the observation that this is an important area, whether it is to do with therapeutic goods or any other good. Australian manufacturers and Australian government authorities should look to ways of using information technology and assisting in the electronic transfer of information as efficiently as possible. I regret that on other occasions I have had to observe that, if there were a manufacturer in the electorate of Scullin who was involved in therapeutic goods and they were looking to take up the opportunities that this amendment will provide with regard to the process of gaining licences et cetera not in a written application but by way of electronic transfer, regrettably the broadband infrastructure in my electorate would probably not be sufficient that these manufacturers could compete. In that context, we note the decision of Telstra to suspend or to do away with their intention to roll out high-speed optical fibre broadband, which would have allowed, whether in this area or other areas, Australian manufacturers to maximise their efforts.

In many of the areas of therapeutic goods, we have allowed the manufacturers, in cooperation with the TGA, to set standards themselves. It is about a balance between the legislation regulation and what we see in other industries with self-determination practices and the like. Within the allowance of the standing orders, I want to draw attention to the front page of the Age of Monday of this week. The article is headed ‘Drug companies accused of manipulating trials’. When we have a piece of legislation like this bill before us, we have to be very careful in the area of therapeutic goods about the way we see the interconnect between the development, processing, licensing et cetera of the drug and then allowing it out into the market. This is one of the great challenges for government. The government has to use bodies like the TGA to carry this out. In the past, when it has come to therapeutic goods such as prescription drugs, the pharmaceutical companies have indicated that they believe that the processes that they have—particularly in the way they market—and the codes of conduct that they and the professions have are sufficient.

Why should this be a question that continues year in and year out? I was the chair of the House of Representatives Community Affairs committee back in the mid-nineties, when we did a major inquiry into, mainly, the Pharmaceutical Benefits Scheme, in which we went from manufacturing right through to the delivery of drugs to the consumer by the prescribing and dispensing practices of the professionals involved.

We have to have a flow of information that allows medical practitioners to be able to decide what drugs or therapeutic devices are appropriate and for the pharmacist to be able to give proper advice. In that, we rely on the pharmaceutical company representatives doing the right thing. The right thing is that, legitimately, they should ensure that those professionals are equipped with the information that enables them to be able to prescribe and dispense in a proper way and to give information to the consumer in a proper way. It is a form of ongoing education for those professionals. The problem is that there is a fine line; those practices can go beyond that information transfer into forms of incentive that move professionals to champion drugs only because of these incentives. That is why we have stories like this.

It is not just a problem that Australia confronts. Anybody who has read the Guardian Weekly, in the British context, over the last few months will have seen that it has been running similar stories. A lot of the manufacturers that gain licences for therapeutic goods under this act are multinational companies. This is a global phenomenon, and we cannot isolate ourselves from it in Australia. I think that is why we have to have a proper regime not only for the way in which we give manufacturing licences for medicinal products but also so that we can certify the audits of overseas medical manufacturers and things like that, which is the intention, in part, of this amendment to the main act. That is why it is very important that all practices in the process should be before us—not just the narrow band that this bill allows.

The main point that I wish to make is that the action being taken by the government by this amending legislation arises out of the audit report of December 2004. There is a suggestion that there are matters arising out of that report that may still need to be addressed, and that is of some importance. I welcome the opportunity to yet again speak on an amendment bill to the Therapeutic Goods Act. As I said, this may not be the most major bill that we have ever had before us, but it is important that Australia does have a regime of administering therapeutic goods that has its basis in safety and efficacy. They have been the issues that have always troubled legislators, because there are incidents where one has to decide: are these incidents just because of the actions of the manufacturer, or are they the result of us not being able to monitor and enforce the way in which the legislation operates? So, with those few remarks on this bill, I indicate my support for the legislation.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

Like previous speakers, I acknowledge the fact that the Therapeutic Goods Amendment Bill (No. 3) 2006 makes only minor amendments to the Therapeutic Goods Act 1989—section 37, to be exact. It allows manufacturers of medicines, blood and tissues to apply for a manufacturing licence electronically, using the Therapeutic Goods Administration’s e-business system. The amendment will make section 37 consistent with other similar provisions of the act that permit or require applications lodged for various purposes to be done electronically.

Given the broad-ranging nature of this debate to date, my contribution will be in a similar vein, although I would like to highlight a couple of aspects that this bill spends some time on. I will start with the fact that the TGA’s implementation of the new computerised system, called the manufacturer information system, to provide more efficient processing of different applications made to various areas of the TGA was introduced in 2004. It was designed to eliminate paperwork and to allow for electronic applications for manufacturing licences for medical products, certification by audit of overseas medicine manufacturers, variation to each of the above and clearance certificates of overseas medicines and manufacturers by assessment of GMP evidence provided by overseas regulatory bodies.

I think that within Health generally we need to put a lot more emphasis on streamlining the use of electronic sharing of information. Across all areas in Health, there has been a call for a greater use of electronic transfer of information using electronic systems to create much more efficient and effective ways of sharing information. When you look at the information that is shared, GPs have in place a system where they electronically transfer information between themselves and hospitals. Unfortunately, it has some problems, and also it breaks down when the information comes back the other way. But, more importantly, there is a breakdown in the transferring of medical information when it relates to specialists. Specialists have not embraced the use of electronic transfer of information in the same way that GPs have.

In an inquiry that I have been involved in with our House of Representatives Standing Committee on Health and Ageing the fact that there needs to be a greater use of electronic transfer of data using electronic systems has been identified as an issue. This has been brought to the committee’s attention by a number of the health experts—people like Scotton and Menadue, who are very influential in the area of health. Doctors have pointed out to us that it benefits the patient. So, as in this area, I think that all areas of health should encompass electronic transfer of information because it benefits all Australians. All Australians use health and medical products and all Australians at some time or another have a need for information to be transferred from one health provider to another health provider. So in commenting on the electronic lodgement of manufacturing licences it is important to highlight that there needs to be a greater use of electronic transfer of medical information and data within Australia.

The next issue I would like to touch on was raised by the shadow minister. It relates to pharmaceutical companies’ use of gifts and the influence that has on the price of pharmaceuticals and, I would argue, on the health outcomes in this country. On many occasions I have raised my concerns about this issue. It has been highlighted again very recently with reports of doctors being given expensive overseas trips and expensive meals and being entertained by the pharmaceutical companies. Roche is a company that has been in the news recently, but in all fairness I do not think we can say it is limited to Roche. I think there needs to be a much more transparent approach to dealings with pharmaceutical benefits and drug companies.

The whip on the other side of the chamber, the member for Blair, pointed to the details of this legislation. I remind the whip that all other contributions to this debate have been broad ranging, even to the extent that the member for Cowper was discussing the minister presenting certificates within his electorate. This legislation does refer to medicines.

Mrs Bronwyn Bishop (Mackellar, Liberal Party) Share this | Link to this | Hansard source

I would remind the member for Shortland that she is ranging far too widely in her comments. I remind her to come back to the bill.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

The matter I am discussing relates to medicines, and it has a lot more relevance to this legislation than the minister presenting certificates in the electorate of Cowper, but I will continue.

Ian Causley (Page, Deputy-Speaker) Share this | Link to this | Hansard source

I would remind the member for Shortland I was not in the chair during that period. I have listened to the other contributions that have been made and I think it does help to mention the bill every now and again.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

Thank you. As I was saying, the Therapeutic Goods Amendment Bill (No. 3) 2006 does look at certification by audit of overseas medicine manufacturers. When we look at the certification of overseas medicines manufacturers, it also brings to mind the fact that some of these overseas medicine manufacturers are engaged in the practice of providing medical practitioners with rewards for prescribing their medication. I believe that is something the government needs to address as a matter of urgency and that it needs to be much more transparent. It is in the interests of all Australians if the government goes down that track.

Another issue this legislation deals with is blood products. It allows manufacturers of blood and tissues to apply for manufacturing licences electronically. That brings me to an issue I am very concerned about. The government is undermining what I believe is the safest blood supply system in the world. We have a number of blood donors. I am a blood donor. I understand that the member for Capricornia is also a donor.

Kirsten Livermore (Capricornia, Australian Labor Party, Shadow Parliamentary Secretary for Education) Share this | Link to this | Hansard source

Ms Livermore interjecting

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

No? She was talking to me about becoming a blood donor. The member for Werriwa is a blood donor.

Christopher Pyne (Sturt, Liberal Party, Parliamentary Secretary to the Minister for Health and Ageing) Share this | Link to this | Hansard source

I am a blood donor.

Cameron Thompson (Blair, Liberal Party) Share this | Link to this | Hansard source

I am an electronic blood donor.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

The parliamentary secretary is also a blood donor. I think that we have the safest system in the world. Once we give our blood, the blood is then processed in Australia into blood products that people need. As well as having given blood, I have been the recipient of a donation, and I was confident of the quality of the blood that I was receiving.

Christopher Pyne (Sturt, Liberal Party, Parliamentary Secretary to the Minister for Health and Ageing) Share this | Link to this | Hansard source

Madam Deputy Speaker, I rise on a point of order on relevance. I really hesitate to interrupt the member for Shortland in her address, but this is an electronic lodgements bill of an administrative nature. Ranging over the issue of whether the government is or is not abrogating the blood supply in Australia is, quite frankly, not relevant. Regardless of what other members did or did not do, I really think the member should limit herself to the precepts of this bill, and I would ask you to rule that way.

Ian Causley (Page, Deputy-Speaker) Share this | Link to this | Hansard source

You make a valid point of order. I have reminded the honourable member on two occasions already to return to the substance of the bill. I think that, if she cannot do that, perhaps she could curtail her remarks.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

Yes. As I was saying, applying for blood licensing will be done electronically. If it is processed overseas, it will happen that way. I was just expressing my concern that the electronic licensing system would not be able to be administered, and we could not be sure of the same safety with blood products that we have now if that system came into play.

The Therapeutic Goods Administration has progressively implemented a major information system project in support of regulatory activities. The Department of Health and Ageing argued that many of the issues raised by the ANAO in its audit were being addressed. They were being addressed because it identified some problems. The audit report was particularly critical of information systems projects in support of regulatory activities. I need some assurance that this will be addressed. The department has said it will be addressed. Electronic data systems are very important to our health system. When it identifies issues such as data management, documentation and record-keeping procedures and recommends that these systems be improved, action needs to be taken immediately. Whilst my contributions to the debate have been pulled more into the parameters of the legislation than the contribution of any other speaker in the debate—

Ian Causley (Page, Deputy-Speaker) Share this | Link to this | Hansard source

I ask the honourable member to resume her seat. That is a reflection on the chair which I will not accept. The member will either address her remarks specifically to the bill or curtail her remarks and sit down.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

I was saying that I would like to conclude my contribution to this debate. In doing so, I support the legislation that is before the parliament and all the comments made by members on this side of the House. I wish to associate myself with those comments. I will end my contribution at that point.

Christopher Pyne (Sturt, Liberal Party, Parliamentary Secretary to the Minister for Health and Ageing) Share this | Link to this | Hansard source

I would like to thank the members of the House who have contributed to the debate on the Therapeutic Goods Amendment Bill (No. 3) 2006the members for Reid, Blaxland, Scullin and Shortland for the opposition and the member for Cowper for the government. This is a very straightforward amendment of an administrative nature which allows the electronic lodgement of applications to the Therapeutic Goods Administration for manufacturing licences, which previously have only been allowed to be lodged in writing—which had been deemed to be a rather archaic hindrance on industry.

The legislation will allow a much easier and more streamlined approach to the administration of applications for manufacturing licences and other applications, which will benefit consumers in that products will get to the market quicker and will benefit industry in terms of saving costs. I know that you, Madam Deputy Speaker Bishop, have a particular interest in the complementary medicines sector, and this will benefit people in the complementary medicines industry and in other areas, as well as consumers. It will cover a number of areas.

Blood supply was mentioned by the member for Shortland. The only issue that the member for Shortland raised which I thought was relevant to the bill was the issue of the ANAO report concerning the TGA’s handling and administration of decisions. That report did not suggest for a moment that any of the decisions had ever been wrong but that they could be more efficiently handled. I am pleased to say to the House that the ANAO report’s recommendations were adopted by the TGA some time ago and have been evaluated. Private contractors have been in the TGA to determine whether the TGA has responded adequately. All the reports to me as the parliamentary secretary have indicated that the TGA has addressed all of those issues and put in place the systems that the ANAO would regard as appropriate. I can assure the member for Shortland, since she sought an assurance, that that has been the case. I am glad that somebody raised a matter relevant to this bill, albeit towards the end of the contributions by the four speakers from the opposition side. With that, I commend the bill to the House.

Question agreed to.

Bill read a second time.

Ordered that the bill be reported to the House without amendment.