Medical education provided or sponsored by pharmaceutical companies fosters knowledge of prescription medicines and encourages appropriate prescribing, Medicines Australia chief executive Dr Brendan Shaw told a health ethics seminar today.

Speaking at the University of Melbourne’s Faculty of Medicine, Dentistry and Health Sciences annual ethics seminar, Dr Shaw said such events must meet the high ethical standard set out by the Medicines Australia Code of Conduct.

“The interaction between pharmaceutical companies and doctors is an important part of ensuring that doctors have up-to-date information on medicines, and patients get the most out of the health system,” Dr Shaw said.

“Doctors attend these events because they derive genuine professional benefit from their engagement with pharmaceutical companies.

“Companies have an obligation to patients to ensure doctors have the latest information about prescription medicines. Healthcare decisions affecting patients must be informed by dialogue between those who make medicines and those who prescribe them.

“You wouldn’t get on an A380 if you knew Qantas hadn’t received any information from Airbus about how to fly it.

“Nor would you want to take a medicine if the prescriber didn’t know how it worked. No one knows more about how medicines work than those who make them.

“But all of these events must adhere to Medicines Australia’s strict Code of Conduct. Gifts are banned, entertainment is banned, lavish hospitality is banned. And information must be balanced, current and in line with Government-approved medicine information.

“Under the Code, the primary purpose of an educational meeting must always be to enhance medical knowledge, and sponsorship must never carry any obligation for the doctor to prescribe a particular medicine.”

Dr Shaw said the Medicines Australia Code of Conduct should apply equally to all manufacturers of prescription medicines, not just to Medicines Australia members.

“It’s disturbing when non-member companies apply a lesser standard – whether by offering Mediterranean cruises or rewards schemes for prescribing and dispensing,” Dr Shaw said.

“That sort of conduct undermines public confidence in the industry.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Brussels, 13 July 2011: A new report on Health Technology Assessment (HTA) processes published today highlights significant areas for improvement in order to accelerate patients’ access to new technologies and innovative medicines, and to make the most of tight public budgets.

The study, jointly commissioned by EFPIA, EuropaBio, Medicines Australia and PhRMA, compares the HTA processes and outputs against best practice principles.

In particular the report shows that the link between assessments and access decisions could be improved. One of the crucial roles of HTA is to improve access to innovative treatments and medicines. However, the report found little evidence that current HTA processes make a difference in terms of speeding up access to medicines for patients or that HTA resulted in better rewards for medicines with higher therapeutic value.

Recommendations from HTA bodies are not always implemented by pricing and reimbursement authorities, and the overall link between HTA and pricing and reimbursement is still unclear in many cases.

Recommendations on the same products also vary greatly between systems and countries. While individual HTA bodies may have different remits and objectives, the variation in how the same products are evaluated suggests inefficiencies and inconsistencies linked with diverging methodologies and data requirements.

The report also shows that many systems could improve their performance towards a holistic approach to assessments. Looking at the full healthcare system and associated costs for society would be more beneficial in terms of efficient allocation of resources. Even though HTA has the potential to assist patients and health practitioners in making informed decisions, in practice, societal aspects are not well taken into account and patients have a limited role in several HTA systems. The report also shows that HTA is mostly applied to pharmaceuticals, and that methods applied to other technologies are less stringent.

However, the report suggests that there are reasons to be optimistic, given that most HTA systems are still in development or are evolving. The report sets the foundation for a regular exercise, which will receive continuous support from the four trade associations. Such regular exercise has the potential to allow consistent assessments of the impact of HTA to be efficiently captured over time, taking into account the impact of current reforms and crossborder activities on access to innovative medicines and the move towards truly patientcentred healthcare systems.

The report & the full list of countries analysed is available here (please follow link)

The key messages of the report is available here: http://www.efpia.eu

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PDF version of the Media Release is also available  206k

Contact People:

Edith Frénoy, Director, Market Access, (EFPIA)
Tel: +32 2 62 62 555,
E-mail: newsroom@efpia.org

Ludovic Lacaine, Director, Healthcare
Biotechnology, (EuropaBio)
Tel: +32 2739 1183/+32 2739 1173,
E-mail: r.travers@europabio.org

Brendan Shaw, Chief Executive, (Medicines Australia)
Tel: +61 2 6122 8500,
E-mail: info@medicinesaustralia.com.au

Mark Grayson, Deputy Vice President,
Communications and Public Affairs, (PhRMA)
Tel: +1202-835-3465,
E-mail: mgrayson@phrma.org

Useful Links

• HTA Comparison report
• Key messages
• www.efpia.eu
• www.europabio.org
• www.medicinesaustralia.com.au
• www.phrma.org

Notes to the Editor

About the report:

Charles River Associates was asked by EFPIA, PhRMA, Medicines Australia and EuropaBio to undertake a comparative assessment of the role and impact of Health Technology Assessment (HTA) in different parts of the world. The objective of the project was to build upon, rather than replicate, the various published studies that have compared HTA systems in order to develop the lessons that can be drawn from different national models in the world. The project started with a literature review of existing frameworks for comparison of the use of HTA focusing on its role and impact (rather than the merits of particular methodologies). The assessment focused on 15 countries representative of the diversity of HTA practices, and with a mix of long-established and emerging HTA systems.

About Health Technology Assessment (HTA):

The International Network of Agencies for HTA (INAHTA) defines HTA as a multidisciplinary field of policy analysis, which incorporates the medical, social, ethical and economic implications of development, diffusion, and use of health technology. HTA is therefore a ‘melting pot’ of the different disciplines needed to assess the benefits of a given medicine, and in some cases, also the costs. HTA experts may include epidemiologists, economists, physicians, pharmacists, and health care managers, among other professionals. HTA is therefore conducted by multidisciplinary groups, using a range of analytical frameworks drawing from a variety of analytical methods. In practice HTA has come to mean a wide range of processes and assessments. For the purposes of this project Charles River Associates used a wide definition of HTA including any process that systematically reviews new technologies in order to provide payers with information to make decisions.

~About EFPIA~

EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 38 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,000 companies committed to researching, developing and bringing to patients new medicines that improve health and the quality of life around the world.

~About EuropaBio~

EuropaBio’s mission is to promote an innovative and dynamic biotechnology based industry in Europe. EuropaBio, (the European Association for Bioindustries), has 66 corporate and 7 associate members operating worldwide, 4 Bioregions and 22 national biotechnology associations representing some 1800 small and medium sized enterprises.

~About Medicines Australia~

Medicines Australia represents the discovery-driven pharmaceutical industry in Australia. Our 50+ member companies supply more than 80 per cent of the medicines that are available to Australian patients through the HTA-based Pharmaceutical Benefits Scheme, as well as providing a range of other medicines and vaccines to the Australian community. Medicines Australia’s members also invest more than $1 billion annually in local research and development, contribute over $4 billion in high-tech exports to the Australian economy, and employ over 14,000 people.

~About PhRMA~

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the leading pharmaceutical research and biotechnology companies in the United States, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.4 billion in 2010 in discovering and developing new medicines. Industry- wide research and investment reached a record $67.4 billion in 2010.

Interview with Medicines Australia chief executive Dr Brendan Shaw, recorded on 27 May 2011 for SCRIP magazine. Topics include: Overview of the Australian medicines industry, Federal Cabinet’s decision to defer new PBS listings, regulatory reform for clinical trials, and gene patents. To view the video in full please follow this link

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Medicines Australia chief executive Dr Brendan Shaw today welcomed the appointment of Dr Suzanne Hill as Chair of the Pharmaceutical Benefits Advisory Committee.

Dr Shaw also congratulated the outgoing Chair Professor Lloyd Sansom, who vacates the position after an illustrious 10 years service.

“Medicines Australia congratulates Dr Hill on her appointment and we look forward to working with her in her new role as Chair of the PBAC,” Dr Shaw said.

“Dr Hill is eminently qualified to bring to the PBAC the high degree of integrity and independence that were the hallmarks of Professor Sansom’s tenure.

“I am sure Dr Hill will bring astute leadership to the PBAC and contribute significantly to ensuring the Committee continues to be held in high regard internationally.

“Medicines Australia looks forward to working with Dr Hill in the years ahead to continue to support the development of the PBAC process in the interests of the community.

“Medicines Australia congratulates Professor Sansom on his distinguished stewardship of the PBAC.

“I personally thank him and wish him well in his future endeavours. He has justifiably earned the trust and respect of industry over the last decade.

“Over that time, industry has worked well with the PBAC to develop the rigor, transparency and community engagement of the process, which now benefits all Australians.

“Under his chairmanship, the PBAC process has become much more open and transparent. The Committee has worked collaboratively with industry to deliver the best outcomes to the community.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

The Government’s Raising the Bar Bill will encourage medical innovation and bring Australia’s IP system into line with IP systems in other OECD countries, Medicines Australia’s acting chief executive Andrew Bruce said today.

The Bill was introduced into the Senate today by Innovation Minister Kim Carr.

Mr Bruce said a “research use exemption” for which the Bill provides will directly address concerns in some quarters that patents on biological materials can potentially stifle scientific research.

“This Bill makes it absolutely clear that scientists are free to conduct research on patented inventions, so long as the purpose of that research is investigation and not the infringement of valid patents,” Mr Bruce said.

“The Bill will raise the threshold of patentability for all fields of technology, ensuring that Australian patents can stand up to scrutiny in any jurisdiction around the world.

“Robust IP laws that encourage the development of new technologies are extremely important to innovative industries such as the Australian Medicines Industry.

“Intellectual property drives innovation, so a strong IP system is critically important to Australia. That is what this Bill delivers.”

Mr Bruce said the Government’s Raising the Bar Bill is more balanced and constructive than the Private Members’ Bill on Gene Patents, which would undermine Australia’s IP system and which is currently the subject of an inquiry by the Senate Legal and Constitutional Affairs Committee.

The Raising the Bar Bill received support from industry, researchers and consumers in their submissions to that inquiry.

“The Government’s Bill will better serve innovators, research scientists and the Australian community. We therefore urge the Parliament to pass the Bill without delay,” Mr Bruce said.

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

The process for listing new medicines on the Pharmaceutical Benefits Scheme has become overtly politicised, following the Government’s announcement today that it would become harder to list new medicines if the Federal Opposition continued to oppose Government health policy.

Medicines Australia’s acting chief executive Andrew Bruce said while the Government had listed some new medicines today, others continued to be deferred by Cabinet despite being recommended by the Government’s own expert advisory committee.

“The Cabinet lottery must end now,” Mr Bruce said.

“There are no apparent criteria to determine which medicines the Cabinet will approve. It has become a fickle and capricious process.

“The Government is bringing politics into clinical decisions where people’s health, and indeed their lives are at stake.

“The Government said today that the future listing of new medicines on the PBS would become contingent on the Federal Opposition supporting Government health policies such as the private health insurance rebate and the chronic disease dental scheme.

“That is unconscionable. The PBS was always meant to be about equitable access to medicines for all Australians. It is now being used as a political football and patients are being caught in the middle.

“The PBS should not be held to ransom by Government’s short-term political agenda.

“The Government’s own expert committee has rigorously evaluated these medicines and found that the health and economic benefits of making them available on the PBS outweigh the costs.

“Cabinet’s decision will mean many patients can’t afford the medicines they need. It’s putting medicines out of reach for many ordinary Australians and threatens to take us into a two-tiered health system.

“It’s bad policy. Australia shouldn’t be a country where we can’t afford to provide medicines for sick people.

“Medicines Australia welcomes the PBS listing for the medicines that were announced today, but we urge Government to end the Cabinet lottery and return to the process of bringing new medicines onto the PBS that has served Australian patients well for decades.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

The establishment of an Australia New Zealand Therapeutic Products Agency (ANZTPA) must not derail important regulatory reform of the Therapeutic Goods Administration already underway, Medicines Australia’s acting chief executive Andrew Bruce said today.

Renewed negotiations to proceed with the establishment of a joint agency were flagged today by the Australian and New Zealand governments.

“The TGA is part way through its own program of extensive reform which will help ensure Australians enjoy more timely access to new medicines,” Mr Bruce said.

“It is extremely important that those reforms are not adversely impacted or delayed by extra workload associated with establishing ANZTPA,” Mr Bruce said.

“The TGA reforms are in their early stages but are already showing signs of strain due to pressures on resourcing. The Government must ensure that the resource demands of the new joint agency do not impede the progress of a reform agenda whose implementation to date has been patchy.

“The TGA must be properly resourced by Government to take on the additional workload which the implementation of a new joint agency will require.”

Mr Bruce said ANZTPA would provide a single point of entry for the registration of new medicines.

“This is a great opportunity to create a single world-class regulatory agency,” Mr Bruce said.

“We are a global industry and many of our New Zealand affiliates are managed through Australia. We recognise that the New Zealand system needs reform and a joint regulatory agency will deliver that reform.

“As a key stakeholder in regulatory reform, Medicines Australia looks forward to contributing to the new ANZTPA negotiations as we did before the earlier negotiations were suspended in 2007.

“The drive for regulatory harmonisation is an important part of our respective governments’ long-standing Closer Economic Relations policy to reduce trade barriers between Australia and New Zealand across all industries.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Medicines Australia today welcomed the Parliament’s passage of a motion that the listing of new medicines on the Pharmaceutical Benefits Scheme should not be “subject to capricious political interference”.

Medicines Australia’s acting chief executive Andrew Bruce said the motion should send a strong signal to Government that Australian voters want a return to the well-established, independent, non-political process for bringing new medicines onto the PBS.

“I congratulate the Parliament for recognising the gravity of this issue,” Mr Bruce said.

“I particularly congratulate the Member for Pearce Judi Moylan MP, the Member for Moore, Mal Washer MP and Tasmanian Senator Guy Barnett for raising this important issue in the House of Representatives and the Senate.

“The Cabinet’s decision to block new listings on the PBS has caused a lot of angst among patients, doctors and the Australian medicines industry.

“The Government is bringing politics into clinical decisions where people’s health, and indeed their lives, are at stake. They are pursuing the political imperative of a Budget surplus and they’re using patients’ medicines to do it.

“This is bad policy, which is hurting society’s most vulnerable.

“It’s putting medicines beyond the reach of many ordinary Australians, and threatens to take us into a two-tier health system, where only the rich have access to the latest medicines.

“Australia shouldn’t be a country where we can’t afford to provide medicines for sick people.

“It’s time for the Government to end this Cabinet lottery and return to the old system that has served patients well.

“These are medicines that the expert Pharmaceutical Benefits Advisory Committee has found to be cost-effective and therefore a sound economic investment. Few, if any, other areas of government expenditure are subject to the same rigorous economic evaluation.”

The motion passed by the Parliament “deplores the Government’s new policy that despite positive recommendations by the PBAC, all applications for listing will be further scrutinised by Cabinet” and that “listing of medicines can be deferred indefinitely”.

–ENDS–

Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Medicines Australia welcomes the Government’s announcement today that it has the support of the Australian Greens to pass the R&D tax credit Bill in the Senate.

The new tax credit will reduce the cost of eligible R&D by 10 per cent and make Australia more internationally competitive as a destination for medical research investment, Medicines Australia’s acting chief executive Andrew Bruce said.

“R&D sustains Australia’s $18 billion medicines industry and provides thousands of jobs,” Mr Bruce said.

“This legislation will provide companies with an additional incentive to boost their R&D investment in Australia.

“Competition for R&D investment dollars from Asia and Europe is fierce, and we have been falling behind. With the right policy settings we can reverse this decline.

“We have the right people in Australia to run these medicine development programs and we have good infrastructure. We just need to make it attractive for companies to invest in Australia.

“This legislation is a big step in the right direction to ensure Australia remains competitive in the face of strong overseas competition.

“It will help keep more of our top research scientists engaged in Australian R&D and attract greater investment to our universities and other research institutions.

“I congratulate the Government, along with the Australian Greens for supporting this important legislation.

“The Minister for Innovation Senator Kim Carr has long been a strong supporter of Australian research in general and the medicines industry in particular.

“His advocacy of the new tax credit is a great example of that support.”

The Australian medicines industry attracted more than $1 billion in R&D investment in 2010. In any given year around18,000 Australians take part in clinical trials.

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Medicines Australia welcomes Bill Gates’ support for strengthened global immunisation programs against infectious diseases.

Speaking at the World Health Assembly in Geneva last week, Mr Gates praised pharmaceutical companies, global health organisations and governments for their work in providing access to new vaccines in developing countries.

Mr Gates told the assembly that vaccines are the best possible investment in global health.

“They can be inexpensive, they are easy to deliver and they are proven to protect children from disease,” Mr Gates said.

Medicines Australia chief executive Dr Brendan Shaw said strengthening programs for immunisation against infectious disease could save millions of lives.

“The medicines industry is committed to investing in the development of innovative, safe and effective vaccines and making them available through partnerships.

“The innovative vaccines industry has long been working with the global immunisation community, to ensure every country has access to these vaccines through sustainable immunisation programs.

“Medicines Australia members are among the companies working at a global level with governments, NGOs and private foundations to make vaccines available at a price those governments can afford.

“Medicines Australia welcomes Mr Gates’ recognition of the contribution the medicines industry is making to solve the world’s global health problems through the development and supply of new vaccines.”

Over the last decade, the biopharmaceutical research sector has invested over $9.2 billion in direct assistance to improve healthcare throughout the developing world.

Innovative pharmaceutical companies are today working on nearly 400 new medicines and vaccines to combat infectious diseases. Many of these medicines are already in late-stage clinical trials or being considered by the US Food and Drug Administration (FDA) for approval for patient use.

Bill Gates’ address to the World Health Assembly is available here

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au