Health Service For Europe Oct02
EU has an average of 7.89% of GDP for health expenditure. Croatia, Czech
Republic and Slovenia can match this but other accession countries spend
far less. Poland's figure is 3.8% although this may be lower than the
actual amount owing to use of tiered accounting. Strangely, life
expectancy for females and males in these countries is not significantly
different despite lower health expenditures. European
countries, with a larger population than the USA, spend about $90bn on
pharmaceuticals whilst the USA spends $190bn.
is highly regulated in almost every European country. Each country, in or
out of the EU, has its own system of regulation for research and
development of new drugs, manufacture, national registration of the
product, advertising, wholesale, retail distribution and safety of the
product. The USA, with its unified market authorization authority called
the Food and Drugs Authority (FDA), is more attractive for the big
pharmaceutical companies for registration of their new products. Although
the EU's European Medical Evaluation Agency has facilitated EU
registration, it continues to frustrate industry because of time delay,
limitations on period of data and patent protection and advertising.
am aware of the mixed composition of the membership of GIRP. Some of your
members are pure full line wholesalers. Others are wholesalers who own a
chain of pharmacies that is managed independently. Some members represent
co-operatives of independent pharmacists who own their own shops but have
common equity in their wholesale business. Despite these differences your
membership has found a common voice that defends a top quality health
delivery system and for you the service to the patient is paramount.
can the EU establish a framework of a health delivery system that will
offer a minimum level of quality and service for its citizens? How can the
EU reform its system of market authorisation and pricing policies to
retain and attract investment from major pharmaceutical companies and
research institutions? How can the accession countries adapt their systems
to match the quality and service of EU Member States?
information based on science is essential and it must be at the centre of
a European Health System. Information about research and development of
new drugs should be in the public domain. The public research institutions
do not always inform the public about the range of diseases for which they
are seeking new drugs.
appropriate period for data and patent protection of new drugs is
essential to sustain research and development and the EU must match the
conditions of the FDA in the USA to ensure that pharmaceutical companies
continue to invest in the EU.
need access to information on diseases, doctors, hospitals and the range
of facilities available to them. The family doctor, the first point of
contact, does not have much time to give such information to the patient.
The patient has to rely on the numerous publications that are available at
doctors' surgeries, the enclosed leaflet in the product package or the
internet. The doctor is unaware of availability of consultant and hospital
bed occupancy to enable him to offer immediate treatment. There is no
databank to which data can be transmitted to allow access for the
consultant and hospital.
The family doctor is unable to perform the medical tests that will allow
him to make a diagnosis. He has to refer the patient to a hospital for
these tests. He is restricted to a budget that often prevents him from
giving the best medicine for the patient's illness. He is
overwhelmed with seeing patients with minor health problems.
The pharmacist is under-employed as he could easily perform medical tests,
treat minor illnesses and prescribe from a limited list of commonly used
medicines. Those of you who own a chain of pharmacies or those wholesalers
owned by co-operative of independent pharmacists have an interest in
pushing this agenda. Such a new role for the pharmacist will yield higher
profits and secure the role of the pharmacist as a link between you and
the patient. Pharmacists in rural areas must be given incentive to
continue to operate.
Too many doctors, surgeons and nurses are occupied in bureaucratic
administration that should be the work of non-medical staff.
OF THE EU
pharmaceutical industry of Central & East European Countries (CEEC)
has seen unprecedented changes over the past decade with market expansion,
growth in volume and value terms, increased market share taken by
international companies, privatisation of domestic companies and increased
integration into that of the global pharmaceutical industry.
Czech Republic and Hungary represent the three largest markets with annual
sales exceeding $5bn collectively. Across the region the per capita
spending varies from $7 in Albania to $115 in Slovenia. The CEECs are
attractive locations to conduct international clinical trials.
Harmonisation of national regulatory requirements with those of the EU are
proceeding well and the CEECs are already giving fast track approvals to
products already approved by the EU’s EMEA.
number of wholesalers and pharmacies has increased substantially since
liberalisation. In relation to population, it is higher than in western
Europe. Pharmacies have a virtual monopoly in supply of medicines. Margins
and mark-ups are state controlled. Payment for supply is often delayed and
this causes considerable difficulty for wholesalers.
of intellectual property rights is weak and limited to process patents.
There is concern about product patents, data protection and some countries
like Hungary have sought derogation for 5 or more years.
are lower in CEECs and will offer good opportunity to sell into the EU as
soon as any block exemption period expires as for Portugal and Spain. This
will attract new investment, better health facilities and the opportunity
of having high quality products and treatment that are at present
unavailable to the mass of the population. The EU price level will decline
with evolving price harmonisation.
IN EU LEGISLATION
European parliament considers it appropriate that national marketing
authorisation should continue in conjunction with EMEA. This will allow
the flexibility for pharmaceutical manufacturers to marketing of
specialised products in a limited area.
the industry will be required to offer uninterrupted supply of medicines
to wholesalers and this should eliminate the quota system industry applies
at present. The regulations specify that the wholesalers supply medication
to hospitals and pharmacies in the concerned member state implying that
such products should not be re-exported to neighbouring states. This
should minimise parallel trade that distorts the supply chain.
enlarged EU should reform the pricing of medicines as supplied by the
industry to the national health systems. At present, the widely different
prices encourage parallel trade and many industries try to minimise this
by applying supply quotas for wholesalers. This situation is not
sustainable and it is important to establish a “bench” price that is
common throughout the EU. This bench price would be charged by industry to
the wholesaler and passed on to the pharmacy or hospital. The manufacturer
would then negotiate the reimbursement to the national government direct
to take account of different per capita spending in the Member States.
This exercise was successfully implemented when East and West Germany
united. Clearly, the model has to be developed to minimise the time frame
for simultaneous negotiation with all EU Member States so that the
medication is freely available throughout the EU.
EU needs to regulate dissemination of information, mechanics of
distribution including ownership of pharmacies, mutual recognition of
professional qualifications right across the health delivery system and
all aspects of product registration and patent protection. Minimum
standards of health and safety, quality standards of medical equipment and
diagnostic reagents, collection and transmission of patient data and
reciprocal facilities and payment criteria for treating patients moving
from one country to another are just some of the areas requiring
there is much to do. I hope, as a pharmacist and a Member of the European
Parliament, to help your organisation and your members, including from the
CEEC, to ensure that the EU formulates policy that will offer the best
health delivery system for all its citizens.