The EU and you

European Commission | europa.eu.int

No Comments

The European Union is, says Martin Terberger, Head of Unit, Pharmaceuticals, Directorate General, Enterprise and Industry, “strongly committed” to ensuring a high level of public health and innovation in the field of pharmaceuticals. In the context of medicines and treatments, his key objectives are “to guarantee access to medicines at an affordable cost, ensure that medicines are safe and effective, and improve the quality and dissemination of information to citizens to enable them to make informed choices about their own treatment”.

What of industry? Terberger is clearly not one to cut off his nose to spite his face, making clear that any and all consumer focus “must be balanced by supporting the competitiveness of the pharmaceutical industry to ensure that Europe continues to benefit from new medicines”.

Europe’s pharmaceutical industry plays a critical role in the industrial and health sectors. It is making a major contribution to achieving the renewed Lisbon objectives and in fulfilling the growing needs in public health. It is a major contributor to Europe’s science base and employment. However, a report on the competitiveness of the European-based pharmaceutical industry, commissioned by the European Commission, concluded that; “Europe is lagging behind [the USA] in its ability to generate, organise and sustain innovative processes that are increasingly expensive and organisationally complex”.

In parallel, the ageing of the European population, the increasing health demands of the European patients and the high level of expenditure for innovative products are putting significant pressure on the social systems and public health budgets of Member States.

In the spirit of resolution, a High Level Group on Innovation and the Provision of Medicines (called “G10 Medicines”) was set up by the Commission to take a fresh look at the problems facing the pharmaceutical sector. The G10 Group presented their report in May 2002. It set out a framework of 14 wide-ranging recommendations. Tracking these recommendations, the Commission created the Pharmaceutical Forum in 2005 to take the process forward around three key themes:

Information to patients on pharmaceuticals
Pricing policy, and
Relative effectiveness.

The Forum met in Brussels on 29 September last year. Afterwards, NGP spoke with Martin Terberger about the key areas where progress is being made and the directions for future work in the form of conclusions for the Forum to adopt.

Information to patients

“The aim of the working group is to advise the Commission on ways to improve the quality of information on authorised medicines available to European patients,” says Terberger. “This will supplement the key role of health professionals in providing information to patients on medicines and health issues more generally.”

As we all know, patients are increasingly loaded with different information, provided by multiple parties with differing objectives and sent through multiple channels (e.g., the internet). What will this initiative do?

Terberger: “It will cover different topics that could help improve electronic and non-electronic information for patients and, in particular, develop a model for a Public Private Partnership that could implement the recommendations in an effective and sustainable way. It will also explore the feasibility of establishing a database of comprehensive and easily accessible information.”

Progress

The Forum’s Working Group on Information to Patients was established in January 2006. It has developed three work streams to:

Develop a model package of information on diseases (using diabetes as a first example).
Consider areas for more harmonised action on information on medicines at an EU level.
Improve patient access to good quality health information in healthcare environments (pharmacies and hospitals and ways to enhance access more generally).

Underpinning the work, says Terberger, is a questionnaire that has been issued to all participants (Member States and stakeholders) seeking details of the main mechanisms for distributing information on medicines and related health issues in each Member State.

Pricing policy

This working group aims to “examine alternative pricing and reimbursement mechanisms to support Member States in fulfilling their commitment towards the G10 recommendations, as well as towards the public health objectives of offering an equal access to medicines at an affordable overall cost, ” says Terberger. “Several factors have generated significant changes in the pricing and reimbursement mechanisms of most Member States during the last years: raising expenditure on medicines, inequity of access to medicines in Europe, and the call for early access to innovative medicines.”

Progress

This Working Group was established in February 2006. It has developed four work streams, which allow a more focused approach to:

Control of expenditure, including use of price control and the variety and impact of national cost-containment strategies in line with Member State responsibilities for pricing and reimbursement decisions and ensuring the sustainability of their health systems.
Access to medicines, for all patients within Europe, including availability and affordability issues.
Market and trade, including organisation of distribution and cross-border trade of medicines.
Transparency of pricing and reimbursement data, exchanged between Member States.

Conclusions

Regarding control of expenditure: “In order to contain rapidly growing pharmaceutical expenditure, Member States make increasing use of a variety of mechanisms, aiming to control levels of price/reimbursement, to rationalise utilisation. To date there has been limited opportunity to evaluate positive and negative impacts of these different mechanisms, notably on containment of expenditure, affordability, access for patients and incentives for industry to bring further innovation.”

Regarding access to medicines: “Not all patients within Europe have equal access to medicines. Different economic strengths of EU Member States may lead to different levels of affordability of medicines for both, patients and public authorities. Certain regulatory measures, market sizes and/or business considerations may lead to differences with regard to timing of availability of medicines.”

Regarding market and trade: “Systems for distributing medicines are organised differently by each of the Member States, in function of local needs and environment. However, in order to ensure access of patients and citizens to all medicines there are specific public service obligations for the supply chain. Parallel imports are not part of organised systems of distribution but they can increase price competition and can offer an opportunity for cost-containment in several EU Member States. In other EU Member States, export of these medicines leads to pressure to accept higher prices and possible stock-ruptures. Such parallel trade might shift reward for innovation from industry towards trading parties.”

Regarding transparency of data: “There is a concern on transparency, consistency and interchangeability of information and data, regarding pricing, price components and related issues, exchanged between different Member States and stakeholders. Although several good initiatives are ongoing in this field, there is need to further coordinate development and exchange of this type of information.”

Relative effectiveness

Member States are now encouraged to apply relative effectiveness systems in order to allow containment of pharmaceutical costs as well as a fair reward for innovation. “Relative effectiveness systems are relatively new for many Member States and rather complex,” explains Terberger. “Nevertheless, the outcome of relative effectiveness is promising as it will help identify the most valuable medicines, both in terms of clinical efficiency and of cost-effectiveness, and will help set a fair price for these medicines.”

Progress

This Working Group was established in February 2006. “As a consequence of the wide variety of national relative effectiveness schemes,” says Terberger, “it was decided to circulate a questionnaire to all participants to get an overview of different relative effectiveness practices in Member States.” This served as basis for discussions on definitions and further objectives and was supplemented by a further questionnaire focusing on the availability and use of different sources for information and data.

Conclusions

The Working Group proposed a future work plan with three objectives:

To develop mechanisms in order to increase the quality and quantity of the available data to carry out an assessment and to consider ways to manage uncertainty. “The lack of reliable data – notably to support the initial pricing and/or reimbursement decision – is one of the key challenges to be addressed,” says Terberger. “And EU cooperation in this field will help to improve the quality of data for Member States and to achieve efficient use of limited resources.” The Working Group will also consider possible ways to share information on assessments made and decisions taken following those assessments, for example by establishing a database/website. The different national legislative backgrounds for these assessments and decisions will be taken into account.
To improve the degree of consensus at European level between Member States on the nature of the data required to carry out cost-effectiveness, relative effectiveness and relative efficacy assessments and on the procedure and the time schedule to provide these data.
To develop a proposal to analyse current assessment processes and to identify good practices. This work could be used to address challenges in the assessment processes in Member States.

“From the first European Community pharmaceutical directive, issued in 1965, to our days,” claims Terberger, “Community lawmakers have striven to ensure that, first and foremost, medicinal products for human use help maintain a high level of protection for public health.”

This lofty aim, the EC – and pharma – has largely achieved. Hopefully the Pharmaceutical Forum will enable Terberger to set his sights even higher – on getting European pharma back to its world-beating best. Much like 1965, in fact.

Martin Terberger: “Parallel imports are not part of organised systems of distribution but they can increase price competition and can offer an opportunity for cost-containment in several EU Member States”

“We cannot afford to fail”

Günter Verheugen, Vice-President of the European Commission responsible for Enterprise and Industry on the importance of delivering better information, better access and better prices.

The pharmaceutical industry is facing a number of serious challenges, matched only by those facing public health. The time has passed that Europe was the pharmacy of the world. True, our industry still has an inherent strength. But we are losing competitive ground to the United States and, increasingly, to China, India, Singapore and others. There are many worrying signals. Let me mention just two:

First, the widening gap in pharmaceutical research: over the last 15 years investment in pharmaceutical R&D has been growing in the US significantly and consistently faster than in Europe[1].

Second, the development of key medicines: in the past, Europe was leading in developing the most successful breakthrough pharmaceuticals. This trend has reversed. In 2004, two thirds of the 30 top selling medicines in the world were developed in the USA[2].

We need to respond to these challenges and our ambition must be equal to the challenges.

Information to patients

The current situation is unsatisfactory, and in my view even unacceptable. If you can speak English and use a computer, you already have as much information on pharmaceuticals as you could possibly want. What you get, however, are often internet sites of dubious quality or even sources from outside the EU offering promotional material rather than information.

If by contrast you don’t speak English and cannot use a computer, the information available to you is very limited.

In our efforts to improve the information on pharmaceuticals as well as on diseases in general, we have to bear in mind some key aspects:

Patients and consumers have a legitimate right to information. This right does not, and must not, extend to advertising.
We need better informed patients. This would help ensure a more rational use of medicines, which could save health care systems millions of euros each year.
We should strive for equal access to information. Computer literacy and linguistic skills should not privilege some patients over others.

We need to decide at what level information is best provided – at a national or European level. In my view, Member States are in the best position to develop information to take account of local traditions, healthcare systems and languages. At the European level we can define, and design, the framework of controls governing information to ensure they are applied equally across Europe. We can also facilitate access to information.

Last but not least we need to consider how to create confidence of citizens, regulators and health professionals in the quality of any information provided by industry.

The legal framework from the early 1990s is not fully appropriate any more. On medicines, advertising to the public is only permitted for self-medication medicines and completely prohibited for prescription medicines. For those medicines, even information is highly restricted. Information on diseases by contrast is much less regulated.

A potential source of information is the industry, which has the knowledge, skills and resources to provide, at least, basic information. National and European regulatory authorities already depend on the industry to provide information for leaflets, labels and national databases. There is no reason why we should not build on this.

I strongly believe that industry should have the right to produce non-promotional information for patients about their own medicines and diseases and to publish it. This information should comply with strictly defined rules. It could be provided on a self-regulatory basis but subject to a robust system of control and quality assurance without creating a big bureaucracy.

Pricing and reimbursement

The starting point of our reflections must be to discuss the fundamental objective of our pricing and reimbursement policies. Do they aim exclusively at cost-containment? If so, there is not much for us to discuss. In my view however, the ambition of our price and reimbursement policies must be to provide optimal service to our patients. Good policies give patients equitable access to the treatment they need and take into account the innovation and added value of medicines.

Do not get me wrong. The objective is not to spend more, but to spend more intelligently. Pricing and reimbursement systems have to allocate our limited resources effectively and free them up to pay for the much-needed innovation of tomorrow. What is needed is a long-term approach, rather than short-term budget fixes.

To get there, we do not need new legislation from Brussels. The way forward is very simple: we need to learn from each other how to do better. Not more and not less.

The diversity in pricing, reimbursement and cost containment models within Europe reflects national health systems. This means that we have a broad but very fragmented experience around the table. We must build on these experiences to develop more shared insights on the most valuable of these practices.
It has become clear that patients over Europe have very unequal access to medicines. This may be for understandable business or regulatory reasons. Nevertheless, I believe that this situation is not acceptable. The Commission is committed to help find solutions, working with Member States, patients and other stakeholders.
Trade and distribution has been raised as a third area including the topic of parallel trade. For some importing Member States, this is a valuable way of cost containment. Some exporting Member States have reported problems with stock-rupture and, more importantly, upward price pressures. I believe that this is a complex issue, but one we cannot ignore.
Member States have made a call for improved networking and exchange of data regarding pricing of medicines. Transparency of data is a valuable tool when taking decisions on pricing. However, for Member States to get these data they also need to provide them. And in this respect we have a very good tool, in the form of the Transparency Directive. I have, therefore, asked my services to take this up at the forthcoming Transparency Committee.

Last not least, a taskforce has been set up to define the value of innovation. A difficult exercise as this can vary depending on your perspective as a patient, payer, company etc. But we need a clearer view on what is valuable innovation, both for Member States to allocate resources effectively and for industry to work on the health-solutions needed.

[1] By 4.6 times in USA compared to 2.8 in Europe. Source: EFPIA?
[2] In 2004. Source: IMS Health.

Excerpted from Günter Verheugen’s opening speech to the Pharmaceutical Forum,?Brussels, 29 September 2006.

Günter Verheugen: “It has become clear that patients over Europe have very unequal access to medicines”

The Magazine

Issue 3

Blog

Sales and the 'Talent Magnet'

White Papers

The EU and you

European Commission | europa.eu.int

More like this...

Mind the gap?

What next for clinical research?

“New science for better decisions”

R&D: The NGP Head-to-Head

European pharma: where next?

Combined competences and a common goal