|
Post by scumbuster on May 18, 2016 21:03:17 GMT -5
BOGOTA, Colombia (AP) — Colombia's government is giving pharmaceutical giant Novartis a few weeks to lower prices on a popular cancer drug or see its monopoly on production of the medicine broken and competition thrown open to generic rivals. Health Minister Alejandro Gaviria's remarks in an interview Tuesday are the strongest yet in an increasingly public fight with the world's biggest drugmaker that could set a precedent for middle-income countries grappling to contain rising prices for complex drugs. Memos leaked last week to a nonprofit group, written from the Colombian Embassy in Washington, describe intense lobbying pressure on Colombia, a staunch U.S. ally, from the pharmaceutical industry and its allies in the U.S. Congress. In one memo, the embassy warns that breaking Novartis' patent for the leukemia drug Gleevec could hurt U.S. support for Colombia's bid to join the proposed Trans-Pacific Partnership trade zone and even jeopardize $450 million in U.S. assistance for a peace deal with leftist rebels. The memos followed meetings between Colombian diplomats and officials from the Office of the U.S. Trade Representative and a Republican staffer on the Senate Finance Committee whose chairman, Sen. Orrin Hatch of Utah, has close ties to the pharmaceutical industry. Gaviria, an economist by training, said the pressure shows the forceful steps that the pharmaceutical industry is willing to take to protect its commercial interests. "They're very afraid that Colombia could become an example that spreads across the region," he said. Government health programs in many countries are being squeezed by high prices for newly launched drugs and by annual price hikes of 10 percent or more for medicines long on the market, and they are increasingly pushing back by demanding big discounts or setting price caps on ultra-expensive drugs. Gaviria denies he is trying to set a precedent in the global fight for lower prices. "For us, it's a question of survival," he said. He noted Colombia's health care system guarantees patients' access to all approved drugs and the budget is straining after years of price rises. In 2009, the government declared a public health emergency after spending on sophisticated drugs had risen tenfold in just a few years. "As the state, you can't just buy everything at the price set by whoever is selling. But unfortunately that's what happened many times," Gaviria said. President Juan Manuel Santos weighed in on the debate Wednesday, saying he supports a "healthy balance" between respect for intellectual property rights and private investment and more access to lower-cost drugs. "When free competition becomes distorted, or abuse takes place, that's when the state has to intervene," Santos said at the inauguration of a factory in Cali that will produce generic drugs. Novartis has rejected Gaviria's proposal to reduce the price for Gleevec to 140 pesos (5 U.S. cents) per milligram. That is less than half the current regulated price but still well above what generic versions cost before they were banned when, after a decade of litigation, a Colombian court in 2012 awarded Novartis an exclusive patent on one of two forms of the drug. In an April 20 letter, Novartis' local affiliate said that it doesn't consider it convenient to initiate negotiations over prices and that the decision to override patents should be taken only in exceptional circumstances and not used as a bargaining tool. Gaviria said he is giving Novartis a little time to reconsider. But if the Swiss company doesn't, he said, he plans to declare access to the leukemia medicine a matter of public interest when he returns from a trip next week to Geneva to attend a meeting of the World Health Organization. Gleevec has been the top-selling drug for Novartis since 2012, bringing in $4.7 billion worldwide last year, or about 10 percent of the company's total revenue. It won't be the top seller much longer, though. Gleevec got generic competition on Feb. 1 in the U.S., which accounts for half of its sales. As a result, in 2016's first quarter, Gleevec sales fell 40 percent in the U.S. and 20 percent worldwide. In Colombia, the patent is due to expire in July 2018. Novartis spokesman Eric Althoff declined to answer questions on what his company is trying to achieve in its talks with the Colombian government. He also would not say whether Novartis enlisted U.S. officials to push the government against ending its patent here for the drug, which is called Glivec in Colombia and some other countries. The Office of the U.S. Trade Representative said in a statement Wednesday that staff recently met with Colombian officials to discuss numerous intellectual property issues but never threatened funding for the peace deal. Novartis says that the drug has been subject to Colombian price controls since 2011 and that two generic versions exist. But the Health Ministry says generic competition that previously existed has been all but driven out by Novartis' aggressive marketing and competitors' fear of prosecution for infringing the patent. What's not in dispute is how much Colombia stands to save from issuing so-called compulsory licenses. Cost for treatment with Glivec is about $15,000 a year, or about twice the average Colombian worker's income. According to a study by the ministry, without competition from generics, the government would have to pay an extra $15 million a year supplying Glivec. More than 100 lawyers and health experts from around the world sent a letter to Colombia's government this week to support its review, which came in response to a petition by local nonprofits including Mision Salud. "The pressure against Colombia is bogus but it's real," said Andrew Goldman, a counsel for Knowledge Ecology International, the Washington-based group that first obtained the embassy memos. "We always assume that this kind of intervention is happening behind the scenes but rarely do you get the chance to see it up close." www.yahoo.com/news/colombia-battles-worlds-biggest-drugmaker-040107014.html?ref=gs
|
|
|
Post by wildstubby on May 18, 2016 21:53:27 GMT -5
As a person who works for a big blue chip pharmaceutical company, I will give you the company line and why I sympathize with Novartis. From the moment a compound is conceived, the clock is ticking, ie. the patent has been filed. During that time the company, (in this case Novartis), has to take their compound from the drawing board and lab to a micro production facility. They will make it in small batches to try to determine the best way to get the most efficient compound. Then begins the clinical trials. There are usually 3 clinical trial and the amount of people increase with each trial. Placebos and real compounds are tracked and results are given. Generally, for every 70 compounds that come to clinical trials, usually one will get to the end. If it is determined that the side effects are minimal and it is proven to be effective, the company will have to spend millions of dollars, to produce this at a large scale. (I know our site had $110MM for a product that was dropped in Phase 3 trials!). The company, (in the US), must submit what are called 'batch sheets', which are nothing more than recipes for producing the compounds at large scale, to the FDA. They usually take about 18 months to review the document and approve them. When this is completed, full scale production can commence, (that is provided that the environmental and labor monitoring groups give the 'green light to production.) When all is said and done, the company has about a 5~7 year window to recuperate their losses from product R&D, micro and macro production, along with full scale production. When a product goes generic, the company looses about half the value of the product. So it has to make a lot of money in the short period of time! While generic companies can go and set whatever price they like and don't have to worry about R&D and start-up costs. Fortunately for me, we make 2 antibiotic products which have large and complex molecules. Generic companies have a difficult time trying to replicate the chains on a large scale so our one product is almost 30 years old. Also, costs increase with the dangers using some of the solvents and compounds, (we have 2 hydrogenators). That is why drugs cost a lot of money.
|
|
|
Post by suba on May 18, 2016 22:25:20 GMT -5
Straightforward choice as I see it. Colombia can stand on it's own two feet and not rely on other countries for financial aid, or carry on accepting money from others whilst obeying the terms laid down for doing so.
Great post by wildstubby.
|
|
|
Post by livinginmedellin on May 18, 2016 22:28:54 GMT -5
The door remains open for Swiss pharmaceutical company Novartis to reach a deal with Colombia to lower the cost of cancer drug imatinib and prevent the Andean country from allowing generic production of the medication, the health minister said. Colombia asked Novartis (NOVN.S) to lower the price of imatinib, which is used to treat leukemia and other cancers, in an effort to save costs for the country's beleaguered healthcare system but negotiations broke down and prompted the country to announce it may declare a compulsory license. Compulsory licenses permit companies to make cheaper generic versions of medications considered vital to public health, overriding drugs patents. "We have not shut the door to negotiations, we're keeping it open, but not for much longer," Health Minister Alejandro Gaviria told Reuters in an interview late on Tuesday. Government sources said the ministry's deadline for reaching a deal is the end of May. The drug, sold under brand names Glivec or Gleevec, was not under patent in Colombia between 2003 and 2012, sparking competition from generic producers whose prices are 197 percent cheaper than Novartis, according to the health ministry. The current patent is valid until mid-2018. The declaration would mark the first time Colombia has used compulsory licensing. Thailand, India and Brazil have come under fire from pharmaceutical companies and the U.S. government for violating patents. "Compulsory licenses are part of the rules of the game for all countries, they are exceptions to free trade agreements," Gaviria said. Each 400 milligram tablet of imatinib currently costs 129,000 Colombian pesos, around $43. The government had proposed to Novartis that the price be lowered to $18.50, but says the company did not take the offer. Imatinib is used by some 2,500 patients in Colombia. "They have been very reticent," Gaviria said. "They say they do not want to negotiate under the threat of compulsory licensing." Novartis, which would be allowed to charge Colombia compensation should a license be issued, told Reuters this week it is actively seeking a resolution. The possibility of compulsory licensing has sparked worries among Colombian diplomats in Washington that approval could endanger $450 million in proposed funding for the so-called Peace Colombia aid package if an end to the nation's 52-year-old conflict with Marxist rebels is reached. An official from the U.S. Senate Finance Committee told diplomats the pharmaceutical industry fears it could set a precedent and may impact other Colombian interests in Congress, according to leaked diplomatic letters. See: www.reuters.com/article/us-novartis-colombia-cancer-idUSKCN0Y9238Novartis had earnings of over $2bn USD in Q1 and they had $4.7 billion worldwide sales of Gleevec last year so a long time ago recouped their development costs for this drug. But they are trying to stick it to 2,500 patients in Colombia for a few more years with a drug that costs Colombians $15,000 a year. In the U.S., Gleevec reportedly costs around $70,000 per year. In India, that price is only $2,500 a year (for a generic version). The difference is that the Indian government has refused to grant patent rights. IMHO the bottom line is that drug prices are out of control and I hope Colombia is successful in lowering the price for this drug and others. All these big pharmaceuticals spend more on marketing than on research...
|
|
|
Post by makopp5 on May 18, 2016 22:34:36 GMT -5
I think the pharmaceuticals should fix their prices on the average income of the country. That`s more fair to poorer countries.
|
|
|
Post by wildstubby on May 19, 2016 20:37:23 GMT -5
makopp5 said: Believe it or not they do! The price of one drug in the US is generally much more expensive than lets say Colombia. Sometimes they will market it under a completely different name. Some countries, (this especially true of the EU), that if you are going to sell your product in that country, XX.X% of it must be manufactured there!
|
|
|
Post by suba on May 20, 2016 9:30:09 GMT -5
The US and Europe already subsidise the Colombian economy to the tune of billions of dollars - if they want they want the post conflict money then they don't get further subsidies - can't have both.
|
|
|
Post by makopp5 on May 20, 2016 10:09:19 GMT -5
The US and Europe already subsidise the Colombian economy to the tune of billions of dollars - if they want they want the post conflict money then they don't get further subsidies - can't have both. How do they subsidize the Colombian economy with billions? I know that Colombia has to pay billions to fight the drugs, because they are obligated by the international community.
|
|
|
Post by suba on May 20, 2016 10:14:52 GMT -5
How do they subsidise the Colombian economy?
Just the US
Economic Department of Defense Security Assistance: $537,272 Development Assistance: $3,758,072 Economic Support Fund/Security Support Assistance: $175,583,556 Global Health and Child Survival: $2,002,511 Migration and Refugee Assistance: $6,800,061 Narcotics Control: $335,996,236 Nonproliferation, Anti-Terrorism, Demining and Related: $4,477,568 Other Active Grant Programs: $3,775,010 Other State Assistance: $4,624,393 Other USAID Assistance: $-497,313 Other USDA Assistance: $2,500 Peace Corps: $1,405,000 Title II: $5,461,900
Military Military Assistance, Total: $100,378,000
|
|
|
Post by makopp5 on May 20, 2016 10:20:40 GMT -5
suba
thanks, but this are not billions. But how much Colombia has to pay for fighting drugs? It would be much cheaper to not get any help from any other country and liberate all the drugs. Why should Colombia pay billions and getting nothing for that? They could earn a lot of tax money from the drugs. Why should Colombia pay for problems in other countries for their drug problems?
|
|
|
Post by suba on May 20, 2016 13:14:10 GMT -5
Makopp I can show you endless pieces of evidence where Colombia admitted to accepting billions of dollars to eradicate the tons of cocaine de Being made and distributed from colombia
|
|
|
Post by makopp5 on May 20, 2016 13:42:10 GMT -5
suba I do not know. Let`s take the UK haw much money do they spend on illegal drugs from Colombia? 3.000.000.000 US$ a year? How much pays the UK to Colombia to fight against illegal drugs a year? T do not think they pay more than 30.000.000 US$ a year.
|
|
|
Post by suba on May 20, 2016 16:59:00 GMT -5
If it's only a dollar a year it's still a subsidy or a handout - and why should the responsibility to destroy the drugs be with anyone but the manufacturers? The problem starts in Colombia, the users are in virtually every country on the planet. Afghanistan is the main producer of opium and i don't hear many people saying that's the fault of the USA or Europe.
|
|
|
Post by makopp5 on May 20, 2016 17:11:00 GMT -5
suba There are 2 points of view. Without drug users there will be no production. So it`s not just a problem of production. Principals of economy.
|
|
|
Post by suba on May 20, 2016 17:20:06 GMT -5
Except that most illegal drugs are highly addictive, and given that one single point the problem certainly does lie with the producers. People aren't generally born addicted to heroin. I take your point but regardless of what other countries do to punish drug users and dealers - like executing their own people in some countries - as long as these highly addictive products flow from their country of manufacture then the problem only gets worse. The addiction is such that people risk death sentences to sell the drugs to addicts and the same addicts accept the ruination of their lives to take the stuff.
If it didn't exist there would be no addicts. The argument that someone is willing to pay for a product does not validate the reason to make it. I might like the idea of owning a nuclear bomb, doesn't mean the guys in Pacho should feel morally right to provide me with one.
|
|
|
Post by suba on May 20, 2016 17:35:47 GMT -5
Getting back to the OP the headline should be "Cancer drug provider fights Colombian rip off"
|
|
|
Post by makopp5 on May 20, 2016 17:38:26 GMT -5
suba so why the UK government can not prevent their citizens from using illegal drugs? Colombia could legalize them in Colombia, the rest will be the problem from the consumer countries. It's not the problem from Colombia, if cities from the UK use drugs produced in Colombia. Colombia could save billions of US$ every year. There is no reason for Colombia to pay such a high price for the incapacity of the UK government to control their citizens. If I buy an illegal arm, The US or UK is also not responsible for the killing done in Colombia.
|
|
|
Post by suba on May 20, 2016 17:47:46 GMT -5
Makopp.
US taxpayers gave 10bn dollars to Colombia to stop the flow of cocaine. That's the US doing more than enough in helping Colombia to deal with the problem. Are you seriously arguing that the US hasn't done enough and the average citizen shouldn't feel right in saying screw them.
US jails are full of drug offenders, full to the brim with them, the US incarcerates more of it's own people than any other country on the planet. Yet despite handing over billions of dollars to another country and handing out decades in prison for anyone dealing in narcotics Colombia still produces the stuff and Colombians still think it's ok to say "well, there's a market"
Let me ask you a question (and please don't take this the wrong way, I'm not implying anything).
There is a huge market for child prostitution - does the same argument apply? The traffickers are after all just supplying those that ask for the children.
|
|
|
Post by makopp5 on May 20, 2016 17:58:02 GMT -5
suba yes, the US has done much more than the whole EU. But it's worthless. It's not working. So, why should Colombia go on to fight drugs. Save all the money and invest better in education, preventing the use of drugs and infrastructure. Fighting drugs is a very bad business for Colombia, no benefit. Only unnecessary costs.
Sorry, but child prostitution is not the same. The UK was a very bad example of abuse of children.
|
|
|
Post by suba on May 20, 2016 18:08:52 GMT -5
So basically you won't answer the question - and btw the UK has nowhere near the record of child abuse as does Colombia, in fact most countries have a better record in that particular arena than does Colombia. We jail our pedophiles, Colombia turns a blind eye, that's why you read about it in the UK press and according to the Colombian press it doesn't exist.
Your argument falls to pieces when you ask a simple question like " is it ok to traffic children to satisfy demand" Because that's your whole argument, just substitute the word children for cocaine. It may be soul destrying to see your argument reduced to that simplicity but it doesn't alter the futility of it. Unless of course you can back up your argument instead of simply saying "that's different"
|
|
|
Post by dandl93 on May 20, 2016 18:12:31 GMT -5
The USA, War on Drugs was never designed to stop drugs.It was designed to start new Goverment Depts and draw new tax funding.Every year these depts needed more ways to increase their budgets if it is to send countries like Colombia money and hire more employees.
|
|
|
Post by billyb on May 20, 2016 18:21:50 GMT -5
No easy solution. Viciuos cycle. New England, even the bucolic little towns are facing tgeir worst heroin epidemic ever. When they started cracking down on street drugs, "middle class users" turned to prescription opioids. Then when they saw a epidemic in in the abuse of those drugs, they cracked down on prescribing them, but by that time all these people were already addicted and turned to heroin as a cheaper, if you can believe that, substitute. But the nature of the beast is that all commerce begins with demand.
|
|
|
Post by suba on May 20, 2016 18:21:50 GMT -5
Whatever it was designed for Dan the money flowed into Colombia on a vast scale and now it seems as if Colombians think it should just keep flowing because they are producing a product with a demand. They also conveniently forget the state this place would be in if it weren't for US money. Now the money isn't flowing so readily the best they can do is elect a government that pardons the killers and traffickers and hopes it all goes away. Same with the argument in the opening post, they want to just copy the results of someone else's hard work and hope that another sucker invests in Colombia and that the whole thing blows over and they can carry on asking for handouts.
|
|
|
Post by billyb on May 20, 2016 18:25:44 GMT -5
BTW, Plan Colombia was never really intended to end the drug trade. It was intended to help Colombia fight the FARC, but it was politically easier to sell it as a war on drugs. I for one, don't care what they called it, i'm grateful for the assistance.
|
|
|
Post by suba on May 20, 2016 18:28:08 GMT -5
"But the nature of the beast is that all commerce begins with demand."
Drug pushers give away samples to schoolchildren and create demand, they actively nurture their future markets. So tell me, who is creating that demand, it's not the children. There is no getting away from the fact that just because someone is willing to pay for a product that it's morally justifiable to supply.
I could ask the same question but lets ask another and see whether it gets answered with something more than "that's different""
North Korea would love a nuclear arsenal and they'd be willing to pay billions for it, given that the demand is there shouldn't someone just arrange a shipment?
|
|
|
Post by billyb on May 20, 2016 18:36:52 GMT -5
"North Korea would love a nuclear arsenal and they'd be willing to pay billions for it, given that the demand is there shouldn't someone just arrange a shipment? BTW, North Korea does already have a nuclear arsenal, and they have paid billions for it. Mostly to Pakistan, and one of their rogue scientists in particular, whose name escapes me. So that shipment has already been arranged and fullfilled. There was a demand and it was met. Morality aside, it is a fact of nature that demand drives supply.
|
|
|
Post by suba on May 20, 2016 18:45:21 GMT -5
Why are you both dancing around the questions? Is it to do with your nationality and cultures?
I'll ask again. Is it ok for child traffickers to supply the demand for their product? It's quite an easy one to answer, there's a demand and someone ready to fulfill it, just type the letter y.e.s or the letters n.o.
That will then either back up your arguments or totally ridicule them. Not answering puts them in the ridicule camp btw. Chop chop.
|
|
|
Post by elexpatriado on May 20, 2016 18:49:35 GMT -5
As a person who works for a big blue chip pharmaceutical company, I will give you the company line and why I sympathize with Novartis. From the moment a compound is conceived, the clock is ticking, ie. the patent has been filed. During that time the company, (in this case Novartis), has to take their compound from the drawing board and lab to a micro production facility. They will make it in small batches to try to determine the best way to get the most efficient compound. Then begins the clinical trials. There are usually 3 clinical trial and the amount of people increase with each trial. Placebos and real compounds are tracked and results are given. Generally, for every 70 compounds that come to clinical trials, usually one will get to the end. If it is determined that the side effects are minimal and it is proven to be effective, the company will have to spend millions of dollars, to produce this at a large scale. (I know our site had $110MM for a product that was dropped in Phase 3 trials!). The company, (in the US), must submit what are called 'batch sheets', which are nothing more than recipes for producing the compounds at large scale, to the FDA. They usually take about 18 months to review the document and approve them. When this is completed, full scale production can commence, (that is provided that the environmental and labor monitoring groups give the 'green light to production.) When all is said and done, the company has about a 5~7 year window to recuperate their losses from product R&D, micro and macro production, along with full scale production. When a product goes generic, the company looses about half the value of the product. So it has to make a lot of money in the short period of time! While generic companies can go and set whatever price they like and don't have to worry about R&D and start-up costs. Fortunately for me, we make 2 antibiotic products which have large and complex molecules. Generic companies have a difficult time trying to replicate the chains on a large scale so our one product is almost 30 years old. Also, costs increase with the dangers using some of the solvents and compounds, (we have 2 hydrogenators). That is why drugs cost a lot of money. I will have a quetion for you on Generic drugs in Colombia later. Actually I can start now. Surely its Okay to save a lot of money and use generic drugs in some cases_ How can you tell when it is good idea?
|
|
|
Post by billyb on May 20, 2016 18:50:56 GMT -5
Nobody is supporting drug sales, or child trafficking comparison either. But it is still a fact that without demand there is no supply. And all your weak attempts at moral shaming aside, that will not changethat. I for one would have no problem with all child traffickers being hanged in the plaza central.
|
|
|
Post by makopp5 on May 20, 2016 18:54:20 GMT -5
suba cocaine is a comodity and children are human beeings, so there is a big difference you can not compare
|
|