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Association of the European self-medication industry:

Ways to improve access to self-care

The Association of the European Self-medication Industry (AESGP) held its 37th annual general meeting in Rome, Italy, from June 6–9. The key topic was how to improve access to self-care. Clare Bellingham reports

UK supports call for closer European co-operation
Regulate claims made about food
Pharmacy management of chronic conditions advocated
Influence of the internet
Danish pharmacists to lose monopoly on 250 medicines

UK supports call for closer European co-operation

Pharmaceutical legislation will become increasingly Europe-based in the next 10 years, predicted Dr PAUL WEISSENBERG, director for the single market, management and legislation for consumer products, European Commission. In the years ahead, a balance would have to be found between what was done at a European level and what should be left to member states.

Speaking to The Journal after the conference, SHEILA KELLY, executive director, Proprietary Association of Great Britain, said that the PAGB supported the principle of closer European co-operation. The reality, at the moment, was that products were having to be reregistered in country after country which was costly. The same data were being used time and time again to go through each country’s regulatory system. If the science was not new, and the product had been safely marketed in five other countries, then this was a nonsense, she said.

According to Dr Weissenberg: “In 2010, we will have 25 to 28 member states. In 2010, we will have a European constitution. In 2010, we will have one European single currency. We will be more closely bound than is currently the case, irrespective of the model of integration, be it intergovernmental, federal or a federation of European states.”

The main goals of the European pharmaceutical policy are:

To guarantee a high level of health protection for European citizens “making safe innovative products available to patients as quickly as possible”.
To guarantee a tighter surveillance of the market by strengthening pharmacovigilance procedures.
To speed up the establishment of the internal market for pharmaceuticals.
To set a framework which fostered competitiveness of European industry.
To meet the challenges of European Union enlargement

“If enlargement is politically the dominant feature in the years to come, we have to ensure that pharmaceutical legislation makes a valuable contribution,” said Dr Weissenberg. “We should aim at a community system that is dynamic, consistent and efficient, and achieves a proper balance between centralisation and decentralisation.”

The mutual recognition procedure had been established as an intergovernmental operation but its main problem was that member states continued to re-evaluate cases. “In the European Union of 2010, we should have the courage to accept the principle that a medicinal product authorised by one member state should be recognised by another member state belonging to the same family. National agencies should be able in 10 years time to have a level of experience, know-how and trust which enables such a true mutual recognition,” Dr Weissenberg said.

Although he predicted that the future would be increasingly Euro-centric, he believed that member states should continue to have a vital role in pharmaceutical authorisation but with more flexibility in the system. “We should not compete between a European agency and 15 or 27 national agencies. We should aim at optimising the complementarity of our relations,” he said.

Proposals had been made in the European Parliament to encourage real discussion towards a resolution of this problem. This was an attempt to make the system work better, Mrs Kelly said.

Regulate claims made about food

Over the past year, there had been considerable debate on the legal framework of self-care products that were currently classified as food, according to Dr ALESSANDRO BANCHI, AESGP president.

A better understanding had been gained for creating rules on ingredients, maximum and minimum dosage levels, labelling requirements and quality assurance. The next step was to clarify the claims allowed for food products. The European Commission had presented a discussion paper on nutritional and functional claims in May and a further paper was expected in the future. “It is possible that through all these activities the borderline between medicines and food in practice be redefined,” Dr Banchi said.

Self-care and self-medication are often referred to as the oldest form of treatment. “However, recent developments in information technology combined with the growing desire of people to take more responsibility for their own health have put the whole area on a new and far more important platform than was the case in the past,” he said.

Pharmacy management of chronic conditions advocated

Finding new over-the-counter indications lies at the heart of moving the industry forward, said JOHN BALL, vice-president, global category management, Pfizer Warner-Lambert Consumer Healthcare. “If we can’t find a way of doing that, and serving the consumer through offering wider indications, then the industry, quite frankly, is not going to move forward.”

New indications under consideration by the AESGP were for recurring and chronic disease management using products that were for long-term use. Examples of such conditions were asthma, diabetes, depression, hypertension, inflammatory bowel disease, migraine, obesity and rheumatism.

AIDAN O’SHEA, president, Pharmaceutical Group of the European Union, said that he felt strongly that there was considerable danger in moving in the direction of handing the management of conditions from the doctor to the patient and pharmacist. This was not only in terms of liability but also in terms of responsibility and competency in disease management. “My view is that the management and monitoring of long-term diseases is the competence of the doctor,” he said.

JULIET SEIFERT, Australian Self-Medication Industry, said that the industry needed to differentiate between products that could safely be in a position of increased access (provided that the information in labelling guaranteed safe, appropriate and responsible use) and products that required a degree of professional advice/counselling and/or ongoing monitoring. This would be especially true as more and more switches for chronic conditions occurred, she said.

If it was in the overall economic and social interests of a country to see certain conditions dealt with more responsibly by consumers (particularly for conditions where ongoing management of the condition could safely be put in consumers’ hands) then, provided they had a relationship with the pharmacist, she thought that it would be in governments’ best interests to consider reimbursement of such products. Control of diabetes, asthma and high cholesterol, once diagnosed, were simply management issues. “Surely it is in the interests of governments to save on ongoing repetitious visits to doctors purely to fill the scripts and to continue to reimburse the product and to allow the people with chronic conditions to be supported by the system. I would think that this is the future of self-medication more broadly,” she said.

Mr Ball said that a key issue was how wider indication availability could occur and public health be safeguarded, particularly in terms of adverse drug reporting. Pharmacists could play a much more active role in post-switch ADR reporting. Another idea was to include an adverse event report card in product inserts for consumers to fill in and send back to manufacturers.

Influence of the internet

The internet is reshaping the self-care industry, according to Dr ROBERT BREUER, senior manager, Accenture. Over the past two years, the pharmaceutical industry had made an increasing financial commitment to the internet, investing between 0.5 and 1 per cent of sales in it. The internet was already having an impact on the self-care industry, for example, through on-line sales by pharmacists and through wholesalers approaching consumers directly. But pharmaceutical companies were struggling with the implications of the internet. A survey of 73 executives in 20 pharmaceutical companies in Europe revealed that 58 per cent needed to improve their internet solutions to keep up with competitors and 68 per cent were struggling with how to capitalise on the internet for sales and marketing.

MOISH TOV, chairman, Skila Inc, United States, said that the internet had allowed equal access to information for the patient and had created an entirely new health care trade. The future was a patient-centred market where the patient could electronically exchange services, products information and knowledge with different providers. The “e-patient” was knowledgeable, proactive and risk-taking.

The ability of pharmaceutical companies to succeed in self-care depended on using the internet as a complement to traditional ways of competing, said Dr Breuer. Competitiveness depended not on launching new websites but on providing a service that reflected consumer needs, anywhere and anytime.

Danish pharmacists to lose monopoly on 250 medicines

Danish pharmacists face losing their monopoly on sales of non-prescription medicines later this year, said PAUL BUNDGAARD, president, Danish Pharmaceutical Association. Unlike in the UK, the current situation in Denmark is that non-prescription medicines, can only be purchased from pharmacies.

The Danish Pharmaceutical Association was concerned that while allowing sales of certain medicines through other outlets meant easier access to medicines it did not mean easier access to professional advice, he said. From October 1, 2001, a selected list of 250 medicines will be available in Denmark from a number of retail outlets, including petrol stations. If a retailer wanted to sell medicines, it would need to purchase a licence that would be examined annually. The requirements for obtaining a licence were that the medicines had to be behind a counter and be sold by someone older than 15 years. Mr Bundgaard said that Danish pharmacists were fighting against the sale of medicines by untrained people. Educational programmes were being set up but retail outlet staff would only be educated on a voluntary basis.

The UK approach to regulation of the sale of medicines was more relaxed than in continental Europe, said MARK CLOUGH, Ashurst Morris Crisp. Changes in the UK to meet patient’s expectations included a more relaxed approach to advertising, an increase in use of OTC medicines (which meant reduced costs to the NHS by removing patients from the state system), a changing professional role for pharmacists (which reduced demands on doctors and consequently costs to the NHS) and there was an increased self-reliance on NHS Direct and online information.