Timely access to safe and affordable drugs is a basic right for consumers. ... network in 2009, called the European netw
FACTSHEET
Access to medicines
Timely access to safe and affordable drugs is a basic right for consumers. However, many consumers across the EU face difficulties in getting the drugs they need.
New drugs should benefit consumers The drugs that consumers need are not being developed. New developments in medicine have made remarkable advances for a limited number of conditions while yielding unimpressive results in most other disease areas such as antibiotic resistance, dementia or depression. What must be done? Research finance should be targeted at areas of public health need. Consumers should not have to pay twice for their medicine, especially when public money has funded drug research. To promote innovation several ‘early access’ initiatives are underway in the EU1. This means some drugs may be approved for use in a small group of patients before full approval is given to release the drug on the market. However, if we do not have enough clinical data, we cannot assume that faster access equals safe drugs. Patients who are given ‘early access’ to these drugs are taking a higher risk and must be given the same protection as clinical trial participants. ‘Early access’ pharmaceuticals should be the exception, not the rule.
Medicines should be affordable Medicine prices are rising quickly. Expensive drugs threaten to erode European health budgets. In a number of countries, the burden is being put on consumers who must sometimes pay out-of-pocket for their medicines. An unaffordable medicine is just as out of reach for consumers as a non-existent therapy. Pressure from drug companies has sometimes led governments to hastily reimburse the cost of new treatments without enough evidence that they work, as seen with anti-virals for H1N1 flu. This practice not only depletes drug budgets but diverts funds away from other proven treatments. What must be done? An EU-wide assessment of the added value of new and existing medicines is needed to guarantee consumers get value for money. Using a ‘health technology assessment’2 helps public healthcare systems choose which therapy to reimburse and avoid investing in treatments which have only marginal benefits for patients.
Initiatives are the European Commission’s Expert Working Group on Safe and Timely Access to Medicines for Patients (STAMP), and the European Medicines Agency’s Adaptive Pathways. 2 Health Technology Assessment is the evaluation of the properties and impacts of health technologies, i.e. medicines, vaccines, etc. The EU established its own network in 2009, called the European network for Health Technology Assessment (EUnetHTA).
1
Rue d’Arlon 80 B-1040 Brussels Tel +32 (0)2 743 15 90 www.beuc.eu @beuc
The prices of some medication have skyrocketed without justification, as for example in the case of key anti-tumour drugs in Italy. Price increases where the drug manufacturer holds a monopoly, or as a result of speculation is unfair to consumers who rely on these medicines. Tackling potential anti-competitive practices needs to remain high on the agenda of the EU. National competition bodies also have a role in protecting consumers from artificially high drug prices. The door should be open to more generics as they can decrease drug prices by 40%3 and Member States should explore new ways to drive costs down.
Medicines should be available at the right place and at the right time Two thirds of hospital pharmacists reported that they face shortages in supplies on a daily or weekly basis. The longer these shortages last, or the fewer alternative medicines that are available, the greater the risk for consumers’ health. Shortages can be caused by manufacturing problems (i.e. a shortage of raw materials), supply problems (i.e. parallel trade, where cheap drugs are exported within the EU and sold at a higher price), or an economic problem (i.e. the financial crisis, pricing policies, or marketing strategies). What must be done? Drug shortages should be investigated at the EU level to find their common causes and possible solutions. Member States should also respect the time limits for pricing and reimbursement decisions as set out in the Transparency Directive to avoid excessive delays in access to new medicines.
3 4
Pharmaceutical Sector Inquiry – Preliminary Report. Factsheet "Prices, time to generic entry and consumer savings" The European Association of Hospital Pharmacists, Oct 2014.
BEUC-X-2015-131 - December 2015
This factsheet is part of an activity which has received funding under an operating grant from the European Union’s Consumer Programme
