EU probe finds companies block cheap drugs

By Nikki Tait in Brussels

Published: November 28 2008

Drug companies have blocked or delayed the market entry of cheaper generic medicines to Europe, adding billions to the cost of medicines to patients, a high-profile report from Brussels has found. Anti-competitive practices range from initiating dispute and litigation to hold up competing products, and filing multiple patent applications for the same medicine, to concluding legal settlements with generic companies which constrain their ability to enter the market.
The European Comission report cited one example where “patent clustering” led to 1,300 patents being filed for a single medicine. Patent ligitation cases involving generics, meanwhile, lasted on average nearly three years, with the generic companies ultimately winning more than 60 per cent of these, it calculated.
Originator companies also concluded more than 200 settlement agreements with generic companies in the EU, according to the report. More than 10 per cent were “reverse payment settlements” which limited the entry of generic medicines and involved payments from the originator to the generics. These payments, the report says, totalled more than €200m.
“These preliminary results show that market entry of generic companies and the development of new and more affordable medicines is sometimes blocked or delayed at significant cost to healthcare systems, consumers and taxpayers,” said Neelie Kroes, EU competition commissioner, as she released the preliminary findings of a pharmaceutical sector inquiry.
Although the report does not name individual companies, Ms Kroes said there was likely to be follow-up action against companies which had breached EU laws.
“It is still early days, but the commission will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached,” she said.
But the pharmaceuticals companies accused Brussels of using ”selective quotations to mischaracterise the industry as anticompetitive”, and of overstating the level and reasons for delays in generic market access.
”The commission’s report does not substantiate in any respect their statement made at the opening of the inquiry that the industry is impeding innovation,” said Brian Ager, director-general of the European Federation of Pharmaceutical Industries and Associations.
The report comes days after the commission announced that it had launched dawn raids on a number of companies – including the UK offices of Teva, the world’s largest generic manufacturer - saying it was concerned about breaches of competition rules or abuse of a dominant position.
The report also backs changes to Europe’s patent system – including introduction of a community patent (a single unitary intellectual property right applying across the continent) and changes to its fragmented patent litigation system.
The sector inquiry was established this year, amid signs that there were fewer new medicines in the industry’s pipeline – a development which drug companies themselves say reflects changing a regulatory environment, rather than any abuse. It began in unprecedented fashion with dawn raids on the offices of large pharmaceutical groups, as the commission tried to gather evidence.

Copyright The Financial Times Limited 2008


Deal reached on NHS drug prices

from BBC news

Drug costs will fall under the plan

The government and the drugs industry have struck a deal which could save the NHS in the UK up to £550m per year. A flexible pricing scheme will mean new drugs can be initially introduced at a lower price, which could be increased if the medicine proves effective.
There are set to be more schemes where the NHS and drug companies share the cost of innovative treatments. An Office of Fair Trading report last year said the NHS spent up to £500m annually on overpriced medicines. The deal is expected to save the NHS around £350m in 2009/10, and around £550m every year after that.In 2006/07, £10.6 billion - 12.7% of the total NHS budget - was spent on drugs.

A more flexible approach to pricing is in everyone's interest.

Health Secretary Alan Johnson

Under the current system, a drug company sets a price for a new medicine when it is launched, and there is little opportunity to change that - so firms set the price at what they think a drug will ultimately be worth, even if there is little evidence for that at the outset. The flexible pricing scheme aims to change that, and means a medicine's cost could go up - or down.

The cost of branded drugs will also be cut.

'In everyone's interest'

Overall, the cost of drugs is predicted to fall from 3.9% from February 2009 with a further cut of 1.9% from January 2010.

The government and ABPI will also look at introducing generic substitution from 2010 - which would mean a pharmacist could give out the cheaper non-branded version of a drug even if the GP had named the branded version on the prescription.

At the moment, that is not allowed.

Health Secretary Alan Johnson said of the new arrangements: "A more flexible approach to pricing is in everyone's interest.

"It gets clinically and cost effective drugs to more patients - providing cheaper options where clinically appropriate - delivers value for money for the NHS and the tax payer, and creates a better market for the pharmaceutical industry while supporting research and innovation."

Dr Richard Barker, director general of the ABPI said it was the first time the pricing agreement between the NHS and the drugs industry had not been purely a financial deal.

"This landmark deal marks a turning point for patients, the NHS and the pharmaceutical industry.

"It is an all-encompassing package that encourages the discovery of new, more effective medicines, while at the same time allowing NHS patients to access these treatments more quickly."


Nigel Edwards, director of policy at the NHS Confederation which represents NHS managers, said throughout the debate over top-up payments for cancer drugs, they had said one part of the solution had to be a new pricing model.

"It is good news that this is now starting to happen although we would caution that there needs to be care taken that this does not land doctors and nurses with a heavier workload of form filling and bureaucracy."

But shadow health minister Mark Simmonds said the government had damaged the UK's reputation as a base for the pharmaceutical industry and failed to address the issue of drugs being available to patients in Europe that are not available here.

And Liberal Democrat health spokesman, Norman Lamb said: "This new development is welcome but not enough on its own to deliver real change."


Racing down the pyramid

Nov 13th 2008 | NEW YORK
From The Economist print edition

Big drugmakers’ love affair with America is coming to an end

FOR many years America has been the heart and soul of the pharmaceuticals business. The adoption of price controls and government-run health systems in Europe, where the industry began, led many drugs firms to pitch their tents in the land of the free market. Keen to encourage innovation and suspicious of big government (until recently, anyway), America has allowed drugs companies to price their wares more or less as they please. As a result, over half of the leading firms’ profits come from America alone. So it might seem odd to suggest that the industry’s future now lies in the developing world. Indeed, for years drugs firms resisted the trend, fashionable in other industries, towards pouring billions into emerging markets. They justified their stance by pointing to weak patent protection and low incomes in those markets. But now the industry has changed its mind. When he took over as boss of Britain’s GlaxoSmithKline (GSK) earlier this year, Andrew Witty declared that emerging markets would be at the heart of his growth strategy. GSK has since agreed a path-breaking licensing agreement with Aspen, a South African “branded generics” firm, and has just paid some $200m for Bristol Myers-Squibb’s Egyptian operations. For its part Pfizer, the world’s biggest pharmaceuticals firm, recently announced a restructuring that makes emerging markets a priority. Jean-Michel Halfon, who is in charge of that effort, says serving customers in developing countries is now “a business, not a charity.” Why the U-turn? The tremendous growth of drugs markets in the developing world proved too tempting to ignore. IMS, an industry consultancy, forecasts that sales in the biggest emerging markets will hit $300 billion by 2017, equal to today’s sales in the top five European markets and America combined. Even before the latest downward lurch in prospects for rich economies, growth in those countries was expected to be much slower than in big emerging markets (see chart). If growth is the carrot luring the drugs giants into emerging markets, the stick is the change in regulatory outlook in America from friendly to possibly frosty. The industry is concerned that Barack Obama, once in office, might allow cheap drugs to be imported from Canada or force Medicare, the government health-care system for the old and disabled, to negotiate big discounts with drugs firms. Peter Lawyer of Boston Consulting Group estimates that the latter reform alone could reduce the industry’s American revenues by 3-10%. In fairness, any move by Mr Obama towards universal health-coverage could boost drugs sales by giving more people insurance, but the industry nevertheless worries about a squeeze on margins. Hence the industry’s zealous push into places like China and India. But if it is to succeed in emerging markets, its strategy and tactics will have to change. In the past, observes Loic Plantevin of Monitor, a management consultancy, Western drugs firms did not fare well because they often lazily “recycled” the products and marketing plans that worked in America for use in poorer countries. But now he thinks firms are doing better. Some are offering products of particular relevance to developing countries, such as treatments for hepatitis B, or combination therapies, which are especially popular in India. Western firms have also dropped their traditional resistance to tiered pricing: Pfizer’s Viagra, a drug for erectile dysfunction, and Merck’s Gardasil, a vaccine against cervical cancer, were both introduced in India at a fraction of their American price. The health-care arm of Bayer, a German conglomerate, has seen its sales in emerging markets soar as it has included more locals in drugs trials and brought new pills to market soon after launching them in America. Some firms are going further, venturing beyond the familiar big cities to more difficult, but potentially more lucrative, territories. Mr Halfon says Pfizer has expanded in the past couple of years into over 130 Chinese cities. His firm has also set up a joint venture with Grameen Bank in Bangladesh to cultivate rural markets for basic drugs by developing “microinsurance” products. Mr Halfon is convinced there is plenty of money to be made among the underserved poor. He thinks the drugs market for those earning less than $3,000 a year is already worth $30 billion annually, and he expects this to increase to $60 billion-70 billion by 2012. Novartis, a Swiss rival, recently unveiled a pilot project to expand into rural India; the firm aims to reach 50m new customers by 2010. Further evidence of emerging markets’ potential comes from the experience of Britain’s AstraZeneca in China. Unlike rivals, which focused on Shanghai and Beijing, its trailblazing marketers pushed into the country’s remote western provinces. The going was tough, but with little foreign competition the firm’s efforts paid off. It has just reported that during the third quarter, sales in mature markets grew by 2% compared with the same period a year ago, but increased by 35% in China—and by 18% in emerging markets overall. It seems that there is indeed a fortune at the bottom of the pyramid.


ISPOR Athens 2008 re-cap

Hello everyone,

back from 14 days of travel I thought I put together a short note on this year's European ISPOR conference in Athens. Certainly the venue was so much better than last year, and the weather for early November couldn't have been nicer, especially over the weekend. Needless to say that Athens had a lot to offer from cultural aspects to entertainment. Hope you all checked out the view from the Galaxy bar at the Hilton - the illuminated Acropolis by night, just amazing.
I have been networking and doing lots of internal stuff therefore didn't attend too many sessions. Just a few comments therefore on points I personally found interesting.
The harmonization discussion of the first plenary session was obviously not new and the idea still reminds me of the approaches taken by centralized economies of the former Eastern socialist block where many people seemed to believe that centralization and broad government interference and small long term planning committees will know better about the preferences of individuals and society, instead of letting the mechanisms of 'trial and error' combined with some healthy competition find out what might work best in each setting. From that perspective, the outcome of this session was to be expected - harmonization of methods and frameworks perhaps possible and useful to some extend, decision making and cost-effectiveness is a local matter - well, what else and rightly so. This topic is now probably sufficiently discussed and needs no repetition.
The old QALY discussion has not come too any new insights either, however here I find is still some work to be done as I am a strong believer that the QALY doctrine of some countries needs to be revisited - especially for the patient's benefit.
The second plenary about improving equity of access was an interesting debate from my perspective, I especially liked the presentation of Tienne Stander from South Africa. A while ago we both presented on biologic treatments at a South African health conference and the wide open discrepancy of basic health care needs versus the availability of highly sophisticated treatment options are especially pronounced in his country and is in need of actions. However, as long as the current health minister down there believes that HIV can be cured with herbal remedies, there is still a long way ahead.
On the poster front I noticed an increasing amount of work in the vaccine area, which I found very interesting as epidemiological models have gotten so much better. Also Oncology - needless to say - was broadly represented.
I haven't paid too much attention to the booths etc. but the usual "suspects" ;) and some new consulting companies where widely represented. Here it remains to be seen how the market will shape the scene up. Clearly with current restructuring in industry and the build up of broader market access capabilities, consultancies who get better at broader economics, understanding of payer systems and pricing strategies / deals will be better positioned as I believe we do not need to invest so much more in statistical model overkill, at least in most areas.
By the way, everyone I was talking to was anticipating the second Latin American conference In Rio de Janeiro, Sep. 2009 to be a huge success - I already offered my Brazilian colleagues a lot of support in order to make that event happen myself ;)

I guess I'll see you all over Caipirinha next year!

As always, best wishes

Czech health ministry cuts prices of reimbursed medicines

The Czech Republic's health ministry has cut ex-manufacturer prices of around 3,000
reimbursed medicines, both original and generic. National legislation regulates prices of
reimbursed medicines only, while all other pharmaceuticals are entitled to free pricing.
Price changes followed an amendment of Act 48/1997 on public health insurance after a
long dispute over the poor compliance of Czech legislation with the EC Transparency
Directive and the national Constitutional Court's requirement that pharmaceutical pricing
and reimbursement be more transparent.
The new prices are based either on the average ex-manufacturer prices in eight EU
reference states (Austria, Estonia, France, Hungary Italy, Lithuania, Portugal and Spain),
set in accordance with the average of the product's three lowest prices in the EU, or refer
to the price of a therapeutically comparable medicine.
Last summer the health ministry reduced the number of products with regulated prices
from 8,600 to 4,100, and the state institute for drug control (SUKL) re-evaluates their exmanufacturer
prices. It determines the maximum ex-factory prices of reimbursed
medicines, and wholesale and retail mark-ups are fixed using a digressive scheme. This
approach allows maximum pharmacy prices for all reimbursed medicines to be
The institute told Scrip that it aims at re-evaluating drug prices rather than at capping
them. It is expected that prices of around three quarters of all medicines now in the reevaluation
procedure will be reduced and those of the remainder will be increased.
All price changes are now being made in transparent individual administrative
proceedings, and companies can appeal against pricing decisions and file their cases in
an administrative court, the SUKL said. All drug suppliers have equal opportunities on
the market, and their businesses are no longer affected by old prices which were set
under non-transparent and unpredictable rules, it added.
It is estimated that the price changes could save around CK1.1 billion ($81.6 million) for
patients and CZK1.6 billion for insurance companies. However, it is impossible to make
an accurate savings forecast because various evidence presented by manufacturers and
insurers during the individual administrative proceedings can have an unpredictable
effect on final drug prices, SUKL said.
The planned savings will be used to extend the list of reimbursed innovative medicines
and increase the number of fully reimbursed medicines (currently around 2,000) by
around one third. The number of partially reimbursed medicines, whose annual cost is
repaid by insurance companies to patients when they spend more than an established
maximum (currently CK5,000), might also be raised. SCRIP - World Pharmaceutical
News - www.scrippharma.com FILED 13 November 2008 COPYRIGHT Informa UK
Ltd 2008