Pharmacy Industry News: Research-Based Pharmaceutical Industry Presentation in Geneva
Research-Based Pharmaceutical Industry Presentation in Geneva
As one of the 189 nongovernmental organizations (NGOs) in official relations with the World Health Organization (WHO), and in line with WHO principles governing relations with NGOs, representatives of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) will be present to listen to the proceedings of the 64th World Health Assembly (WHA).
The IFPMA will follow with particular interest decisions made by member governments on global health challenges directly involving the research-based pharmaceutical industry, such as pandemic influenza preparedness and fake medical products. The IFPMA will be taking particular note of the outcome of the World Health Assembly’s discussions on the health related Millennium Development Goals (MDGs) and non communicable diseases (NCDs); as both demonstrate the need for global leadership and partnerships. The federation will also be interested in discussions on specific disease areas such as HIV/AIDS, malaria, and cholera.
The World Health Assembly agenda includes a review of the report of the WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness (OEWG/PIP) which scopes out a global system to prepare for future pandemics. Recognizing a shared responsibility to help secure the world against future pandemic influenza outbreaks, the research-based pharmaceutical industry has engaged constructively in the OEWG/PIP process and stands by the collaborative commitments it has made to address this challenge. The Assembly will also consider the report by an external panel to review the “Implementation of the International Health Regulations (2005)” and the response to the 2009 H1N1 pandemic. The findings of the report and its recommendations together with the OEWG report represent an important basis to prepare and fight future pandemics and underscore the essential need for close collaboration between many different stakeholders.
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The issue of substandard/spurious/falsely-labelled/falsified/counterfeit medical products is on the WHA agenda. The WHO has a crucial leadership role to play in helping to ensure that medicines everywhere are of high quality, safe and efficacious, and that they are also what they purport to be. The IFPMA supports the global effort to secure high quality medicines, and also hopes there will soon be consensus around priorities on fake medical products. The IFPMA’s “Ten Principles on Counterfeit Medicines” are based on the belief that the production and distribution of deliberately falsified medicines are an important threat to patients’ health and a serious global crime which calls for a global course of action to be taken.
The IFPMA believes this 64th WHA is an important milestone in shaping the global approach that seeks to address the millions of deaths that are caused every year by non communicable diseases — 14 million of which are premature and could be averted or delayed. Given the sheer enormity of the challenge, in particular in low income and emerging countries, the approach needs to involve not only governments but also the private sector, nongovernmental organizations and each of us as individuals. Governments can have a direct impact by introducing or reinforcing fiscal and legislative measures to discourage, for example, the use of tobacco, by imposing restrictions and bans. At the same time, awareness-raising and communications campaigns are a key factor for prevention.
The Assembly will also review the health-related Millennium Development Goals (MDGs). In this area, IFPMA member companies have a strong track record with over 200 long-term partnership programs through which the research-based pharmaceutical industry works to improve health in low and middle income countries and make a tangible contribution to the health related MDGs, tackling HIV/AIDS and other communicable diseases such as cholera, and malaria. At the half way point of the MDGs, in 2007, IFPMA members had made available nearly USD 10 billion dollars’ worth of health assistance for access and capacity building in low and middle income countries, and over 1.3 billion public health interventions. The scale of their efforts is set to continue to achieve the MDGs in 2015. In addition, the IFPMA’s member companies have been supporting the WHO in the fight against neglected tropical diseases through major research and development investments and donations for many years, but more recently there has been a stepping up of the industry’s efforts in response to WHO’s call for help. In 2010 there were five new major donation announcements, and the number of tropical disease-related research and development projects is higher than ever before.
New drug bill could hurt pharmacies, says local pharmacist
A Bass River pharmacist is concerned for his future and those of his counterparts across the province with the passing of new provincial legislation.
Bayside Pharmacy owner Charles Beaver said Friday’s passing of Bill 17 brings a lot of uncertainty to the industry.
The bill is intended to provide fair drug prices for Nova Scotians, but passed before the province and the Pharmacists Association of Nova Scotia had agreed to a new tariff schedule covering items like dispensing fees.
Beaver said the average pharmacy in Nova Scotia would lose $150,000 in the first year of the new bill and $220,000 in subsequent years.
“If nothing is done to address these losses pharmacies will be forced to reduce staff, hours and services,” he wrote in an email to the Truro Daily News. “I expect many sleepless nights in the coming weeks as we are left to wonder how these staggering losses will be recovered.”
The bill includes a cap on the price of generic drugs, compared with the price of equivalent brand drugs. The province says legislation will be phased in during a year to give pharmacies time to adjust.
The price of generic drugs through Pharmacare will be 45 per cent of the price of equivalent brand drugs on July 1, 40 per cent on Jan. 1, 2012 and 35 per cent on July 1, 2012.
Health Minister Maureen MacDonald estimated Nova Scotians would save about $1.6 million, including about $900,000 for seniors, when the 35 per cent cap is in place for a full year.
“The cost of prescription drugs to taxpayers through the Pharmacare programs is also growing at an astounding rate,” MacDonald said in an opinion piece available on our website. “Government spending on drugs through Pharmacare has more than doubled in the past eight years and, last year alone, the total cost was $300 million. This cannot continue unchecked.”
The Pharmacy Association of Nova Scotia repeatedly asked for the bill to be delayed.
“The hurry is the problem,” Beaver told the Truro Daily News. “All we’re asking is work with us, we’re literally begging.”
Beaver anticipates rural communities would be hit first because they have lower volumes. If the price per prescription filled is reduced under the new tariff schedule, the profitability of the stores is at risk.
Colchester North MLA Karen Casey said she and her Liberal caucus exercised every avenue possible to get the governing NDP to delay the bill so the tariff schedule and Bill 17 coincided with each other.
“We all have little pharmacies in rural parts of our constituencies and we’re concerned about their ability to survive,” she said.
“If that drug store (in Bass River) should close, we have a population that has two choices: they can drive to Parrsboro or they can drive to Truro.”
There are some members of the community who do not drive so they would have to find a way to get into town and Casey fears they would not do that because of the inconvenience.
She said the health minister made reference to a list of protected pharmacies across the province, but would not provide the Liberals with a copy of the list or how much money was there to support them.
“It seems like they are withholding information,” Casey told the Truro Daily News yesterday. “I cannot understand why you would ever withhold that because you just get communities anxious and upset, you get pharmacists who don’t know if they’re going to be able to stay open or not.”
Maine drug disclosure rules under fire by GOP majority
Republican lawmakers are moving to repeal state laws requiring drug companies to disclose financial and other information.
The legislators, with the backing of the pharmaceutical industry, say disclosure rules should be left to the federal government, which is moving to set up transparency requirements that are similar to Maine’s.
Democrats, meanwhile, are trying to block the efforts. They and advocates for affordable drugs say Maine’s disclosure laws save millions of dollars a year by keeping costs down and helping to negotiate lower medication prices for MaineCare patients.
The dispute split the Legislature’s Health and Human Services Committee last week, with all eight Republicans supporting two related bills and all five Democrats opposing them.
Debates in the full Legislature have yet to be scheduled, but the bills appear to be following the same track as a controversial health insurance reform bill that divided the two parties before it was passed by the Republican majority in a final vote Monday.
“The general theme this session is to stop making Maine more difficult than other states” for business, said Rep. Meredith Strang Burgess, R-Cumberland, sponsor of the repeal bills. “We certainly want to make sure we’re being smart (about regulation), but at the same time not going too far and letting the free market prevail.”
Rep. Sharon Treat, D-Hallowell, said the disclosure laws – most of which she sponsored – are under attack because they have successfully driven down drug costs.
“The bottom line is that repealing these things is absolutely about improving the bottom line of the drug companies and taking away tools of the government that right now help the state get some of the best rebates in the country and help prevent fraud,” Treat said.
One bill, L.D. 719, would repeal state laws that require drug companies to report to the state wholesale pricing information, amounts spent on drug marketing and the results of clinical trials.
A related bill, L.D. 1116, would repeal a Maine law that says pharmacy benefit managers who negotiate group prices with drug companies must disclose side payments and other financial information.
Maine’s disclosure laws for the drug industry are among the most comprehensive in the nation.
Strang Burgess, the sponsor of both bills and co-chair of the Health and Human Services Committee, said Maine’s requirements are overly burdensome on business.
“Maine has all these things that are a little more aggressive and confining,” Strang Burgess said. “It becomes a patchwork quilt (of varying rules) if you are a large company operating in different states.”
She said the state will not face any increase in drug prices if the bills pass, largely because the federal government is expected to require similar disclosures in the next year or two. “Other sources of information will be available,” she said.
National disclosure rules are part of the Affordable Care Act, which Maine and other states happen to be trying to repeal in court.
Strang Burgess also said the law requiring pharmacy benefits managers to disclose financial information has driven some group negotiators out of the state and reduced competition, actually making drug prices higher.
Treat, on the other hand, called the suite of proposals a gift to the drug industry, which failed to defeat the disclosure rules years ago in the Legislature and courts.
Treat agreed that the federal government is moving to require some public reporting, but said those rules are not yet in place and will not relieve states of their responsibility to guard against overcharging, kickbacks or fraud.
“Some of it is covered by the feds and some of it isn’t,” she said. “The federal government has not yet collected any data.”
Maine needs to keep requiring companies to disclose their average wholesale prices because the federal government has not yet set up any system for collecting that information, she said. The pricing disclosures help the state save millions of dollars a year in spending by MaineCare.
And the ability to negotiate savings is especially critical at a time when thousands of seniors may lose their drug coverage because of cuts to MaineCare, Treat said.
“As far as I’m concerned, this is being taken away by the majority at the behest of the drug industry so there are no checks and balances. We won’t have the means to go after them that we have right now,” she said. “Maine taxpayers and consumers will be the losers.”