The problem with market access
In 2011, the IMS analyzed data regarding new drugs introduced to five European markets—Austria, Poland, Hungary, Slovakia
and the Czech Republic—in the period from January 2008 to March 2011. The findings were striking: on average, Czech patients
received access to new products up to three years later than their neighbors in Austria, and up to 1.25 years later than Slovakian
patients. 93% percent of drugs deemed 'most important' lagged considerably in market introduction, and the Czech Republic
was never the first among neighbors to introduce the 30 key drugs in Europe.
Calculation vs. argumentation
The delay can be attributed to a running theme: the complexity of the Czech system, and the high entry barriers. Regulators
have themselves acknowledged the unwieldiness of the dense framework. The AIFP's Jakub Dvořáĉek observes, "The issue is that
a new drug can only be introduced on the Czech market after two other countries introduce it in Europe. Hence, we must always
wait. My question is, why? What constitutes the major difference between the Czech Republic and a neighbor like Austria?"
Pavel Březovskı, Director, SUKL
Richter Gedeon's František Gyürüsi, whose company offers both generic and innovative products, illustrates. "In the Czech
Republic," he says, "it is difficult to predict the time when a product will be given the go-ahead for launch. Price and reimbursement
negotiations take anywhere from one month to a few years, depending on the product. For instance, this year, we settled with
the authorities upon price and reimbursement levels for a simple generic product within one month. However, for original products,
the period has taken up to one or two years."
Jiří Havránek, Country Manager, Glenmark CR
Gyürüsi, like his counterparts at Teva and Glenmark, does praise the improvements in time-to-market for generics. The generic
association CAFF notes that the Czech Republic's shortening of generic registration procedures has been a long time coming—and
is simply in line with EU directives; nonetheless, Glenmark's Jiří Havránek is quite satisfied with today's expediency: "New
legislation is shortening time-to-market quite dramatically. Generics players receive both price and reimbursement levels
much faster today. In our previous experience, products took over 200 days to reach the market; now, we are looking at approximately
70 days, and in some cases even faster. The regulation is definitely favorable for companies; but it is also favorable, of
course, for patients."
Yet for innovators, market access is not only encumbered by timelines; companies are also facing an increasingly intractable
regulator. One challenge is that many international pharmaceutical organizations standardize their drug registration procedures
for Europe, the Middle East and Africa (EMEA)—but not all indications are accepted at the local level. Another is the question
of whether the negotiations will yield an economical output for the manufacturer. It is up to managers and their market access
teams to argue for a favorable price and reimbursement level, and proving added value is today a tricky game.
Jean-Philippe Duc, Country Manager, Amgen CR
Given difficult conditions in market access and an environment further blemished by low prices, will companies launch new
innovations here? Janssen CR Managing Director Jane Kidd, echoing her colleague at Teva, enunciates a foreboding observation
regarding the small size of the Czech market. Companies will be hesitant to damage their regional business by accepting an
unworkable deal in a small-volume country like the Czech Republic.
"Something I believe the Czech authorities should consider," says Kidd, "is working together with the industry to take account
of the relative size and impact of countries such as ours on the region. Most pharmaceutical companies that operate internationally
will consider the region as a whole, and work to ensure that access for their medicines is open and fair. This includes taking
account of access, pricing and reimbursement mechanisms.
"With the marketplace challenges our government is facing, both they and the industry need to consider more innovative approaches
and mechanisms to ensure that access to innovative medicines can continue. The authorities must question whether they want
new innovative medicines on the market, but at the same time it is up to the industry, of course, to prove that these medicines
add value. The effects of not addressing this will not be seen immediately. However, if over time innovative products cannot
gain access, this will be to the detriment of patients."
Kidd further notes that in the Czech market, "the review of medicines and their prices and reimbursement is continuous and
ongoing"—"so companies have to work to maintain their products in the marketplace." Many managers have commented that such
product maintenance is one of their greatest challenges.
But is the industry being treated unfairly? Are barriers truly too high? Or are pharmaceutical companies demanding a premium
for drugs that bring little added value?
Minister Heger, with characteristic firmness, offers his opinion: "The notion that the government is short-sighted, and ineffective
from a strategic perspective, is essentially just a matter of politics. We must have proofs. Where the proof is available,
the decisions can be made. What is sure is that drug companies always ask for a higher price for their new products, but we
cannot afford to pay a premium for incremental innovation. We can instead help companies to demonstrate value: for instance,
by running pilot projects in a small proportion of the population."