A Health Service For Europe Oct02

The 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.  

Healthcare 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. 

I 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.

How 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?


a)      Authentic 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.

b)      An 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.

c)      Patients 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.  


a) 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.  

b) 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.    

c) Too many doctors, surgeons and nurses are occupied in bureaucratic administration that should be the work of non-medical staff.  


The 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.

Poland, 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.

The 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.

Protection 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.

Prices 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.


The 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.

Furthermore, 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.



The 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.

The 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 harmonisation.

Clearly, 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.