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The following articles have the tag Medicines Australia
MERCK Sharp & Dohme (MSD) has been fined $125,000 and ordered to issue corrective statements relating to its promotion of Vytorin (simvastatin/ezetimibe).
MERCK Sharp & Dohme (MSD) has been fined $125,000 and ordered to issue corrective statements relating to its promotion of the drug Vytorin (simvastatin/ezetimibe).
FEDERAL Health Minister Tanya Plibersek has defended the PBS as providing choice to Australian consumers, after a think tank said the government could save $1.3 billion a year by being tougher on drug companies.
THE federal government could save $1.3 billion each year by demanding drug companies cut the cost of generic medicines, a think tank says.
THE federal government must extend pharmaceutical patents to make up for the increasing amount of time getting regulatory approval, the medicines industry said last week.
PFIZER has been fined for breaches of the Medicines Australia Code of Conduct over misleading promotional material for the arthritis drug celecoxib (Celebrex) and pneumococcal vaccine Prevenar 13.
MEDICINES Australia (MA) member companies have been given two years to improve transparency of payments and sponsorship made by pharmaceutical companies to individual healthcare professionals in an ACCC ruling that has also slashed the expected authorisation period for the MA code of conduct.
THE AMA has expanded its guidelines on ethical relationships between doctors and industry to give greater prominence to a doctor’s responsibility to act in the best interests of patients regardless of their interest with industry.
DRUG maker Abbott Australasia has been fined $100,000 after Medicines Australia (MA) ruled the company breached its code of conduct by making claims about its cholesterol management drug Lipidil that were insufficiently supported by scientific testing.
DRUG maker Abbott Australasia has been fined $100,000 after Medicines Australia (MA) ruled the company breached its code of conduct by making claims about its cholesterol management product Lipidil that were insufficiently supported by scientific testing.
THE Australian Competition and Consumer Commission (ACCC) has issued a draft determination that would let the pharmaceuticals industry self-regulate for another three years, but says it must improve its disclosure of relationships with healthcare professionals.
PATIENTS with hepatitis will continue to be refused subsidised access to two potentially life-saving drugs – despite both carrying the endorsement of the Commonwealth’s own advisory committee – as the result of the federal government’s approval system for listing new drugs on the PBS.
PATIENTS with hepatitis will continue to be refused subsidised access to two potentially life-saving drugs – despite both carrying the endorsement of the Commonwealth’s own advisory committee – as the result of the federal government’s approval system for listing new drugs on the PBS.
PHARMACEUTICAL companies have been urged to exercise caution when using social media as part of consumer education after a Medicines Australia code of conduct committee hearing was asked to examine an online video posted by Merck Sharp & Dohme (Australia).
PEOPLE in need of expensive medicines not listed on the PBS could be waiting years for financial relief after the federal government continued its stop-gap approval system for new products, stakeholders have warned.
PEOPLE in need of expensive medicines not listed on the PBS could be waiting years for financial relief after the federal government continued its stop-gap approval system for new products, stakeholders have warned.
THE TGA has dismissed suggestions a steady decline in medicines approvals is linked to its evaluation process, instead blaming “global economic conditions”.
A NEW “transparency taskforce” has been established by Medicines Australia following a rush of submissions to the Australian Competition and Consumer Commission (ACCC) calling for full transparency of industry payments to healthcare professionals.
NOVARTIS has been fined $100,000 for breaches of the Medicines Australia Code of Conduct over claims made about its COPD treatment indacaterol (Onbrez Breezhaler).
GREENS senator Dr Richard Di Natale has confirmed he will introduce legislation forcing drug companies to disclose payments to individual doctors, after Medicines Australia declined to include the measure in its new Code of Conduct.
GREENS Senator Richard Di Natale has confirmed he will introduce legislation forcing drug companies to disclose payments to individual doctors, after Medicines Australia declined to include the measure in its new Code of Conduct.
PHARMACEUTICAL companies would like to disclose their financial dealings with individual GPs but will consult the profession first to avoid “witch hunts”, according to Medicines Australia CEO Brendan Shaw.
MEDICINES Australia (MA) may have a fight on its hands as it attempts to have its new code of conduct authorised, with the Greens and medical activists calling for full disclosure of individual inducements to doctors.
Boehringer Ingelheim has been fined $125,000 and ordered to shut down its ‘Vote Against Stroke’ website, which highlighted the government’s deferral of a PBS listing for Pradaxa, by Medicines Australia’s code of conduct complaints committee.
A HEALTH economist has questioned why the federal government locks in drug prices with the pharmaceuticals industry for several years at a time, suggesting savings of up to $1 billion a year may be possible by paying market price.
THE pharmaceutical industry’s claims to effective self-regulation have been questioned after a major international company was fined $40,000 for breaching rules preventing it from spruiking its products in the media.
THE pharmaceutical industry’s claims to effective self-regulation have been questioned after a major international company was fined $40,000 for breaching rules preventing it from spruiking its products in the media.
REDUCTIONS of up to 82% in the cost of about 170 PBS medications have been welcomed by generic medicine makers, but doctors’ groups say they still don’t go far enough.
THE generation that brought the world Facebook, Justin Bieber and planking has an even less impressive notch on its collective belt – being number one when it comes to online self-diagnosis and taking unprescribed medication.
MERCK Serono has been fined $20,000 over a news item that was found to have been promoting the drug Movectro directly to the general public. The company was originally fined $75,000 under the Medicines Australia Code of Conduct, but that amount was reduced on appeal. The fine related to a complaint from a member of the public which alleged a Channel 7 news item about Movectro was misleading and unbalanced as it only highlighted the positive attributes of the product without providing any negative aspects or potential side effects. The ...
THE Federal Government has today caved under pressure from patient advocacy groups, announcing that 13 new medicines previously on hold after PBAC approval will now be listed on the PBS. Click here to see the 13 new medicines to be listed on the PBS Health Minister Nicola Roxon said additional listings and new indications for several other drugs would be available on the PBS from 1 September and cost the Government more than $200 million. Sixty groups, including the Consumers Health Forum, Diabetes Australia and Alzheimer's Australia, had been campaigning for the Government to ...
INDUSTRY experts have warned bigger changes are ahead for the pharmaceutical industry, arguing the Federal Government’s decision to have Cabinet vet all PBAC recommendations to list medications on the PBS signals it is keen to pursue greater savings. Datamonitor healthcare analyst Erin Brady told last week’s Future of the PBS conference in Sydney that while the Government’s decision had come as a shock to the industry, it was simply the latest step in ongoing Government efforts to control the growing cost of the scheme. “Certainly it was a surprise [but] healthcare costs are growing enormously and for ...
HEALTH Minister Nicola Roxon has told industry groups today the Government would not budge on its decision to defer listing medicines recommended by the Pharmaceutical Benefits Advisory Committee. The minister met representatives of the Consumers Health Forum, the AMA and Medicines Australia in Melbourne this morning. Medicines Australia chief executive Dr Brendan Shaw said Ms Roxon gave the industry a good hearing but the meeting had failed to resolve the issue. “We are concerned the Government has confirmed the Budget is so tight Australia can’t afford to fund new medicines,” he said. AMA vice-president Dr ...
HEALTH Minister Nicola Roxon will meet representatives of the Consumers Health Forum, the AMA, Medicines Australia and the Generic Medicines Industry Association in Melbourne tomorrow to discuss Government delays in the listing of new medicines on the PBS. The summit talks follow recent incidences of medicines recommended by the Pharmaceutical Benefits Advisory Committee for Government subsidy being deferred by the Labor Cabinet, including treatments for lung disease, chronic pain, schizophrenia and enlarged prostate. A catch-up vaccine to prevent pneumococcal disease in young children was also delayed. Another seven new drugs recommended by the committee for PBS ...
PHARMACEUTICAL companies are under pressure to monitor their sales representatives, after new research revealed a visit to a GP is becoming a growing marketing tool in Australia. The research, from Cegedim Strategic Data, showed spending on pharmaceutical rep meetings with GPs rose by 9.3% to $47.7 million from 2009 to 2010. The increase came as the entire pharmaceutical industry spending on marketing – including detailing, mailing, print advertising and samples – rose by 9% to $353.5 million. Dr Ken Harvey, adjunct senior lecturer at La Trobe University’s School of Public Health, said pharmaceutical companies monitored all ...
HEALTH minister Nicola Roxon has been forced to defend the Federal Government's decision to defer the listing of seven medicines on the PBS despite recommendations from the Pharmaceutical Benefits Advisory Committee that they be included. The unprecedented announcement drew criticism last week from Medicines Australia and Shadow Health Minister Peter Dutton, who argued that patients may not be able to afford the medicines without government subsidy and may have to forgo possible treatment. The medicines deferred include combination medications oxycodone and naloxone (Targin) for chronic pain, as well as budesonide and eformoterol (Symbicort) for lung disease. ...
MEMBERS of the Generic Medicines Industry Association (GMiA) have published their first quarterly report detailing the education and hospitality provided to prescribing healthcare professionals. The report is the first to be published since conditional authorisation – which requires members to disclose all hospitality and educational events to healthcare professionals – was granted by the Australian Competition and Consumer Commission (ACCC) in December. The most costly event was provided by Ascent Pharmaceuticals, at a total of $3502 for 25 attendees – an average of $140 per attendee. For the quarter 1 April to 30 September 2010, member ...
PATIENTS are set to save up to $21 per script for medicines under looming reforms to the PBS. The National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010, set to be debated in the Senate this week, is estimated to create $1.86 billion in PBS savings and improve consumer access to certain medications. Speaking at the National Press Club last week, Medicines Australia chairman Will Delaat said patients would benefit from improvements to PBS processes, which would also reduce the time it takes for a new medicine to be listed on the PBS. “The benefit for consumers ...
THE Generic Medicines Industry Association (GMiA) wants rules governing the transparency of its dealings with pharmacy to be relaxed. It is seeking concessions from the Australian Competition and Consumer Commission (ACCC) on demands for greater transparency of relationships between pharmacists and generic drugs manufacturers under its new Code of Practice. The ACCC last month announced plans to grant a conditional three-year authorisation to the GMiA Code of Practice. However, it imposed the condition that association members – who supply more than 90% of generic medicines – will be required to disclose all educational events and promotional ...
AUSTRALIA is missing out on a number of medicines because of poor intellectual property laws, says Medicines Australia. Outlining their election priorities, Medicines Australia chief executive Brendan Shaw said the period of data exclusivity under Australian law should be increased from five years to 10 years to bring the country into line with the rest of the world. Such laws allow innovator pharmaceutical companies to maintain control of pharmaceutical formulas, and thus other companies from manufacturing cheaper generic versions of the same drug. “When you look at the international standards as far as data exclusivity is ...
PHARMACISTS will face the same level of scrutiny as doctors in their dealings with pharmaceutical companies, with generic manufacturers now required to report on hospitality, loyalty schemes, incentives and gifts offered to pharmacists. The Australian Competition and Consumer Commission (ACCC) announced plans to grant a conditional three-year authorisation to the Generic Medicines Industry Association (GMiA) Code of Practice. But it has imposed the condition that GMiA members – who supply more than 90% of generic medicines in Australia – will be required to disclose all non-cash incentives for pharmacists, as well as doctors. GMiA CEO Kate ...
TOUGHER regulation of the therapeutic goods industry is on the horizon with the Federal Government now pushing for a universal advertising code and more teeth for the TGA to deal with offenders. Parliamentary Secretary for Health Mark Butler last week released a position paper warning the industry to get tough on poor advertising practices by 2012 or potentially face a federally-enforced code of conduct. Medicines Australia and the Generic Medicines Industry Association applauded the call but did not comment on whether they would review their codes. Dr Ken Harvey, senior research fellow at La Trobe University, ...
TOUGHER regulation of the therapeutic goods industry is on the horizon with the Federal Government now pushing for a universal advertising code and more teeth for the TGA to deal with offenders. Parliamentary Secretary for Health Mark Butler last week released a position paper warning the industry to get tough on poor advertising practices by 2012 or potentially face a federally-enforced code of conduct. Medicines Australia and the Generic Medicines Industry Associ-ation applauded the call but did not comment on whether they would review their codes. Dr Ken Harvey, senior research fellow at La Trobe University, ...
PHARMACEUTICAL companies have spent more than $12 million on educational events during the first quarter of 2010, the industry’s peak body Medicines Australia has reported. Thirty-six Medicines Australia member companies reported hosting 5857 educational events, with more than 140,000 medical professionals attending. The average cost of the event per head was $87.40, a slight increase on the $71.33 reported in the previous educational event report. A Medicines Australia spokesperson noted the number of events was slightly lower than usual, but added that this was due to the inclusion of January, which is known to be a ...
A MAJOR policy flaw in the Pharmaceutical Benefits Scheme (PBS) is putting patients’ lives at risk, says Medicines Australia. Any drug likely to cost the PBS more than $10 million a year must receive mandatory approval from Cabinet before it can be listed on the schedule. However, Medicines Australia chief executive Dr Brendan Shaw (PhD) said this approval process was delaying access to some vital medicines by 12 months. “The $10 million threshold was introduced in about 2001 and that number hasn’t been indexed for inflation since then... We have data to show if you [doubled the ...
PBS reforms detailed in the Federal Budget are set to create $1.9 billion in savings for Commonwealth coffers, but the news has not been greeted warmly by all pharmaceutical companies. Under a five-year agreement struck between Medicines Australia and the Federal Government, all PBS medicines on the F2 formulary will be subject to price disclosure policies. From 1 October, manufacturers will be required to disclose to the Government the actual price at which the medicine is sold to wholesalers and pharmacies. Over the time, the price at which the Government pays for these medicines through the ...
THE Generic Medicines Industry Association’s (GMIA) first ever code of practice has been written off by experts as inconsistent and lacking the teeth of the code for innovator pharmaceutical companies. The new code lists the principles GMIA members must abide by when promoting their products to health professionals, and sets out a series of fines for those who breach it. The top fine is $75,000, significantly less than the top fine of $250,000 that Medicines Australia (MA) can impose on its members. “The principle-based approach...encourages members to think about the reasons behind their activities, as opposed to ...
Dr BRENDAN Shaw (PhD) has been officially appointed Medicines Australia (MA) chief executive, filling the post vacated last year by former chief Ian Chalmers. Dr Shaw has been the acting chief executive for the past three months, but has been associated with the organisation for the past six years, leading the MA Health Policy and Research function. Before joining MA in 2004, Dr Shaw was an adviser to former shadow minister for innovation, industry and trade Dr Craig Emerson, and worked as a Federal Government consultant on economic development, innovation, industry analysis and public policy.
THE Medicines Australia Code of Conduct was yesterday given the final stamp of approval from the Australian Competition and Consumer Commission (ACCC), spelling the official end of brand-name reminders and product advertisements in practice software. The green light for the code comes as the Medicines Australia Code of Conduct Committee released its annual report, showing pharmaceutical companies were hit with a total of $1.42 million in fines in 2008-09. This was down from the $1.83 million recorded in 2007-08. The new Code of Conduct will take effect from 1 January and will significantly tighten regulations around pharmaceutical ...
THE Federal Government must offer greater policy support to innovative pharmaceutical companies if research and development efforts into new medicines are to reach their full potential, according to Medicines Australia chair Will Delaat. Addressing the National Press Club last week, Mr Delaat said that, while industry was supportive of health reform – including pricing reform to the PBS, the Government still had a responsibility to pay a fair price for medicines. “Pharmaceutical manufacturers must be entitled to expect fair reimbursement for innovation of medicines and new development of existing ones,” he said, adding that the prices the ...
THE Federal Government has signalled it may take control of ethical marketing codes of conduct for all drug and device manufacturers if industry can’t reach consistent and satisfactory standards under self-regulation. Parliamentary Secretary for Health Mark Butler said that although the Government supported industry self-regulation, it “would not close the door on direct action” in pursuit of a level playing field for innovator, generic and OTC drug manufacturers and medical device makers. “There is no reason why there should be one ethical standard for innovator pharmaceutical companies and a different, lesser standard, for generic companies,” Mr Butler ...
The rules governing the relationship between doctors and the pharma industry have been tightened yet again. Elizabeth McIntosh looks at the key changes. FIRST, lobster, caviar and fancy restaurants were given the flick. Now, the ubiquitous brand-name pens, mugs and umbrellas have suffered a similar fate at the hands of the increasingly stringent Medicines Australia (MA) Code of Conduct. As the relationship between doctors and pharma companies continues to occupy the spotlight, more eyes are turning to the code for guidance on the issue of transparency. Writing in the MJA last ...
LINKS between pharmaceutical companies and patient representative groups will soon be subject to greater scrutiny under the revised Medicines Australia code of conduct, which also spells the end of brand reminders such as pens. The latest update of the code, which governs promotional activities of pharmaceutical companies, will require companies to disclose any financial or in-kind support they offer to patient groups. However, they will not be required to disclose an exact dollar figure. The move has been welcomed by academics as a positive first step, but Healthy Skepticism chair Dr Jon Jureidini said more transparency was ...
GPs have a new ally in their efforts to stamp out unauthorised brand substitution by pharmacists, with Medicines Australia recently weighing into the debate. Concerns raised by pharmaceutical companies that some pharmacists were substituting generics for branded medications against GP instructions, have prompted Medicines Australia to meet with the Pharmaceutical Society of Australia (PSA). Medicines Australia CEO Ian Chalmers said he had used the meeting to request that the PSA remind all of its 15,000 members of their obligations to adhere to correct dispensing procedures. “We have anecdotal evidence that there is a degree of unauthorised ...
SANOFI-Aventis has been fined $25,000 by Medicines Australia after its controversial relationship with the Baker IDI Heart and Diabetes Institute was found to breach the industry’s code of conduct. Medicines Australia’s code of conduct committee met earlier this month and, at the time of going to press, Sanofi was still considering whether to appeal. Under the partnership, Sanofi had agreed to give the Baker Institute 25 cents for every prescription of its anticoagulant medication Plavix filled through retail pharmacy.
THE controversial new partnership between a pharmaceutical company and one of Australia's leading research institutes will face the scrutiny of Medicines Australia, following a complaint that it unduly influences GP prescribing behaviour. Last week, Sanofi-Aventis announced that for every Plavix script dispensed through retail pharmacy, it would donate 25c to the Baker IDI Heart and Diabetes Institute. The partnership is expected to net the institute about $500,000 this year. However, Dr Ken Harvey, senior research fellow at La Trobe University's school of public health, has lodged a complaint with Medicines Australia, claiming the new partnership breaches ...
PHARMACEUTICAL companies spent more than $30 million on educational events during the last half of 2008, the industry’s peak body, Medicines Australia, has reported. Forty Medicines Australia member companies reported hosting 18,060 events with more than 444,000 medical professionals attending. The average event cost per person was $67.67. The six-month spend was down by $2.6 million on the 1 January to 30 June 2008 figures, however the number of attendees jumped by 2224. Events ranged from journal clubs and conference packages to event sponsorship. Medicines Australia said 99.9% of events complied with the body’s code ...
MEDICINES Australia is considering a call from pharmaceutical company Eli Lilly to develop a system that will give marketing activities a definitive stamp of approval, to ensure they do not breach the industry watchdog’s code of conduct. The call from Eli Lilly Australia comes after the company was given a $100,000 fine for breaching the code last year with a public press statement relating to its antidepressant Cymbalta (duloxetine). Rival company Lundbeck lodged a complaint with Medicines Australia, alleging the press statement breached the code by suggesting Cymbalta could be used for unapproved indications, specifically pain relief. ...
THE number of educational events sponsored by pharmaceutical companies has increased in the past six months, however fewer are being referred to the Medicines Australia Code of Conduct Committee for potential code breaches. The latest education events report from Medicines Australia – covering 1 January to 30 June this year – found pharmaceutical companies had spent more than $32.6 million on 15,836 sponsored events. During the second half of 2007, they spent $31 million on 14,633 events. Only 21 events were referred to the committee for potential code breaches, less than half the number referred in the previous six months. “[Independent monitoring shows] ...
NEW requirements for mandatory reporting of pharmaceutical company involvement in medical educational events has seen fines handed out by Medicines Australia more than double in 12 months. Figures released in the Medicines Australia Code of Conduct Annual Report show a rise from $695,000 in 2006-07 to $1.65 million in 2007-08. The total number of fines also rose from 19 to 33 in the same period. Chief executive Ian Chalmers said the spike had been caused by the new reporting requirements which came into force in mid-2007. “We have not had a mechanism ...
GPs have been reassured that CPD points later found to be tainted by undisclosed pharmaceutical company input will not be revoked. The RACGP stressed GPs would not be penalised, after announcing a review of its CPD event sponsorship guidelines to ensure all pharmaceutical company input was declared. The assurance came as the college faced controversy over its failure to adequately police CPD events to ensure its guidelines were being adhered to, including admissions that the policing of all events was impossible ( MO , 7 March ). Dr Peter Maguire, chair of the college’s QA&CPD ...