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When new rules for medicines are to be adopted within the EU, they have not gone far enough. Several of the proposals need to be tightened in order for patients in Europe to have better access to medicines. This is the opinion of the most important body in Swedish healthcare policy.
The EU Commission’s proposal for new legislation on medicines aims to create a better balance between 1) access, 2) making them available and also 3) at reasonable and affordable costs. These are the bill’s “three A’s” (Availability, Access and Affordability in English). These aspects are of central importance for medicines to reach all the way to patients who need them.
The availability of medicines must be improved in healthcare, nursing and for patients. But the legislative proposal that has been drawn up by the EU Commission and that has begun to be negotiated between the member states is not sufficient, says Swedish Association of Local Authorities and Regions (SKR) in a statement.
It will not improve the conditions for making medicines available all the way to patients. Many of the proposals risk driving costs in an unsustainable way. It is important to promote innovation and development, but the proposal currently takes too much account of industry. A fast track for approval does not automatically provide quick access to drugs for the patient in the end, biomedical analysts argue.
Do not increase the cost of medicines
The legislation is intended to, for the European market, regulate the requirements that need to be placed on medicines. It must also deal with which assessments should take place at the EU’s medicines authority EMA and how it should take place. These ambitions are good. However, a stronger connection is needed between the anti-competitive protections that are granted and the EU’s competition legislation. This is because there are financial interests within the pharmaceutical industry that could abuse market advantages.
Current proposals will drive up drug costs.
Already today, the pharmaceutical system is surrounded by extensive regulations. The new bill from the European Commission means that the complexity is further strengthened.
Another aspect is that EU legislation should not be allowed to limit democratic self-determination at local and regional level. Nor should the free right of prescription be curtailed. Different types of effective and safe treatment options must also be possible for the caregivers to use.
There are already working systems to emulate
In the Swedish healthcare system, pharmacies can exchange a drug for an equivalent one with the same substance but at a lower price. Several different competing drugs are needed for the same type of diagnoses and ailments. It creates competition and lowers costs for patients and public healthcare.
Several competitors on the market also reduce the risk of drug shortages.
SKR’s section for healthcare have made a proposal that the new legislation should contain a mandatory requirement for comparative studies in order to get a drug approved. A comparison of this kind, where a new medicine is assessed in relation to a treatment that has been used since before, can provide the caregivers with useful facts and information.
Stimulate research into new treatments
It is also important to stimulate research to develop different treatments that can benefit patients, especially if they are in great need. Various rare health conditions currently lack treatment.
Legislation therefore needs incentives that more effectively target the disease state. It is the patients’ needs that need to be in focus, such as weighing up different treatment options and rewarding the drugs that provide documented added value for the patients. Another request from SKR is that the incentives be limited and become more restrictive for drug development around rare diseases, in favor of unmet medical needs where there are real treatment gaps that need to be addressed.
Although the EU Commission’s proposal addresses areas that need to be strengthened, SKR believe that it is insufficient when it comes to improving the availability of medicines that are financially sustainable for those who have to pay.