domingo, março 12, 2006
Negociar preços de medicamentos na Europa
By Elisabeth Rosenthal International Herald Tribune
TUESDAY, NOVEMBER 15, 2005
Ever since the single European market came into being, Europe has been able to enforce uniform standards for everything from air quality to cigarette packet warnings.
But when it comes to one of the most crucial aspects of caring for health - the purchase and supply of medicines - it is every country for itself.
The availability and price of a drug depend almost entirely on where the patient lives, having been set during negotiations among individual countries and makers. Smaller, poorer countries often pay higher prices for the newest drugs because they lack the market volume to win discounts.
A one-month supply of Prozac, an antidepressant, costs 18.49, or $21.66, in Italy but 40.48 in Slovakia. A 40-milligram tablet of simvastatin, a popular drug that fights high cholesterol and heart disease, could cost as much as 3.40 in Austria and 1.05 in France, according to the Euro-Med-Stat database, a European Union mechanism for tracking pharmaceutical sales.
"There is something really wrong with this system," said Pietro Folino-Gallo of the Italian National Research Council, who runs Euro-Med-Stat. "Each county starts fresh with negotiations. What happens to patients has nothing to do with science or medicine."
Governments collaborate little, if at all, when negotiating drug prices even though those prices have been rising 5 percent a year since 1997. The 25 EU member states spend a combined 100 billion on medicines each year. Drug costs eat up about 15 percent of medical budgets in Western Europe, and can run as high as 50 percent, as in Slovakia.
Wealthier countries like France and Norway still reimburse patients fully or nearly fully for most prescription medicines that cost ever more, though escalating costs threaten the solvency of many national health plans.
But poorer countries like Bulgaria simply cannot. Bulgaria, scheduled to join the EU in 2007, already spends 30 percent of its health budget on medicines. So the poorest Europeans face the highest co-payments; often, they simply do without state-of-the-art medicine.
Dr. Nina Gotcheva is one of Bulgaria's most eminent physicians. She rattles off findings from the latest medical journals and international conferences with ease. But these lessons are too expensive to benefit the patients in frayed suits and babushkas who pad through her hospital's graying halls.
She would like to treat patients with acute heart attacks with a high dose of Atorvastatin, a cholesterol-lowering drug. She would like to give simvastatin - another drug in the statin family taken for long periods of time, if not for life - to patients with high cholesterol or high blood pressure to prevent them from getting heart disease.
"But you can't even discuss this," Gotcheva said in her tidy office, a poster of the Golden Gate Bridge on the wall, courtesy of Bristol-Myers Squibb, which makes the statin Pravachol.
Of 200,000 Bulgarians with coronary artery disease who should be on statins, only 30 percent can take them, she said, because neither the patients nor the national health service has the money. Simvastatin costs 1.05 a pill in Bulgaria, and 50 percent to 70 percent of that must be paid by the patient.
"These are the most important drugs for prophylaxis and prevention in people with heart disease," she said with a sigh. "But I have no solution. The solution is financial and political, not medical, for them."
Over all, Europe spends more than 8 billion a year on statins, economists say.
Once a drug has been approved for use in Europe, manufacturers decide where to sell and how to market it. The approval process is generally coordinated for all European countries as a bloc, handled by the European Medicines Agency in London.
But pricing, in contrast, is determined separately. The cost of a drug is determined in often protracted negotiations among drug makers and health and finance officials. Countries, especially wealthy ones that have been able to negotiate discounts, keep the decisions secret for fear of losing a good deal. Consumers generally cannot take advantage of a lower-priced medicine across the border, since prescriptions apply only in the country of origin.
In some countries the new drug may not be sold at all, if potential profits are not deemed adequate. Only 20 percent of approved drugs are sold in the Czech Republic, for example, because it is not a profitable market, said Dr. Sabine Vogler, a health economist at the Austrian Health Institute in Vienna.
Price tends to be tightly linked to potential sales volume - the higher the drug maker's potential profit, the better the price a country can demand, experts say. Drug companies have little incentive to cut deals - like offering rebates - with poor or small countries.
On the other hand, finance officials in poor countries sometimes drag their feet in reaching a price accord on beneficial but costly drugs, in the hopes of delaying a new expense. In Poland, for example, where outlays for imported drugs rose to $1.5 billion in 1998 from $258 million in 1991, price negotiations sometimes drag on for four years after a drug has been approved by the European Medicines Agency, as officials protect their budgets by simply refusing to pay the higher prices demanded by pharmaceutical companies. That effectively keeps innovative medicines off the market.
Once a price is established, governments must decide whether they will reimburse patients fully for the cost, a decision that depends not on scientific merit but on budgets. In many of the former Eastern bloc countries, like Bulgaria and Hungary, governments spend less than 400 per person a year on health care. In the 15 countries that were in the EU before its expansion last year, governments can afford to pay more than four times that amount.
Norway, for example, provides statins for free to all patients who are prescribed the drugs; statins account for 10 percent of its health budget.
In France, only patients with severe long-term heart problems may take the drug at no cost, while French citizens with less urgent illnesses pay 35 percent of the cost of statins prescribed to them.
But patients in Bulgaria pay as much as 70 percent, and many who would have been treated with statins in Western Europe are not eligible at all.
"Even if a drug is cost effective compared to others, you have to think if your country can afford to pay 100 percent or only a part," said Borislav Borissov, a former head of Bulgaria's national drug agency who now runs a pharmaceutical consulting firm.
Health officials are blunt about the trade-offs. "It is sometimes a choice of this: Do you buy medicines or pay doctors' salaries?" said Dr. Dusan Keber, a former Slovenian health minister.
Many smaller and poorer countries attempt to link the prices they are willing to pay to deals cut by larger countries. As a matter of policy, Slovenia caps prices it will pay for new drugs at 80 percent of the price paid to drug companies by a trio of richer countries (France, Italy and Germany), although the cap is not applied to "innovative" drugs.
But attempts to control cost are easily subverted. Drug companies introduce drugs first in Germany and Britain, where there are no price controls, to set a high price as a benchmark, said Dr. Robert Launois, director of the Network for Health Economics Evaluation, a Paris-based research concern.
The Baltic states have sought a way around this by experimenting with joint purchasing. But in general, European countries lose out by failing to act together for lower prices, economists say.
The present alarm over bird flu in Europe, for example, has touched off a perverse pricing war for the drug Tamiflu, which all countries are stockpiling to combat the virus. Each country negotiates its price, and there is no public information about what they are paying.
"Even information that should be open to all, that would allow a market to work, is not," Vogler said. "Countries who are getting a great deal, they don't want that out in the open."
Politicians in the richer West European countries have continued to focus on whether a new drug is beneficial; cost is no object, they tell voters, when it come to health care. But with the astronomical prices of the newest drugs, that approach is harder to maintain. In France, total spending on drugs equals more than $600 per person, according to the Organization for Economic Cooperation and Development.
"The situation here is becoming very hypocritical because no one talks about cost - it's considered vulgar," Launois said. "But inevitably the cost story is there behind every decision."
Generic drugs may prove a partial solution as drugs come off patents, although drug patents typically last about 20 years. Simvastatin has recently come off patent in some European countries and will lose protection in the rest by 2006, and analysts expect spending to fall. In Bulgaria, Prozac, which used to cost 50 a month and so was rarely used, is now made generically by a local company that charges 3.60 a month.
Acknowledging the cost of new and improved medicines, Bulgaria's national health system raised the budget for cancer drugs this year to $150 million, from $25 million. But hospitals are still forced to borrow from other parts of their operating budgets to afford them, and patients sometimes do without, said Georgi Mihaylov, an oncologist who is head of Bulgarian Medical University.
"We are asked to comply with EU standards on pollution," Mihaylov said, "so why can't we cooperate more on the cost of health care?"