A law intended to help patients get medical treatment anywhere in the European Union has moved a step closer, following an accord between the European Parliament and EU member states.

The agreement on the long-contested patients’ rights directive is an important step for EU health policy, although the law is far narrower in scope than that originally envisioned by the European Commission. The final text is a victory for EU member states, traditionally suspicious of the EU encroaching into their welfare systems.

Member state ambassadors approved the draft law yesterday (Tuesday 21 December) following a final round of negotiations between Parliament and Council last week.

Crucially, the law will require patients to get advance permission from national authorities before going abroad for treatment in many cases. Patients will need “prior authorisation” if their treatment involves a hospital stay of more than one night, hi-tech equipment, is risky, or raises quality or safety concerns.

National authorities can also refuse patients permission to go abroad if the treatment would expose the patient or others to risks (e.g. infectious diseases), or if the standard of healthcare in the other country raises safety concerns. Significantly governments may also turn down requests to go abroad if delays at home are “medically justifiable”. This means, for example, that a UK health authority could refuse to reimburse a British patient to go to France for a hip replacement if they could justify the waiting time on medical grounds.

Patients’ rights have been on the EU’s agenda for years, following a brace of European court rulings in the 1990s that upheld patients’ rights to reimbursement for treatment in other EU member states.

Françoise Grossetête, the French centre-right MEP, who led negotiations for the Parliament, said “the negotiations had been sensitive because numerous member states were reluctant with regard to this proposal for a directive”.

Nevertheless she added: “Patients can soon benefit from clear rules if they decide to seek care in another member state of the European Union.”

The European Parliament lost a bid to require national governments to reimburse patients their travel expenses and hotel costs. Instead, the law simply states that governments “may decide” to do this.

Member states also weakened provisions on European co-operation on e-health and safety standards, although they did not succeed in removing them altogether from the law.

A senior European Commission official said: “We are pleased because it was the best possible outcome at this stage and it is an outcome that ensures the directive can now come to life.”

The law still has to pass two formal hurdles – a vote in the European Parliament, expected in January, and approval by EU ministers, expected in February or March. This will pave the way for the law to come into force in 2011, although governments will have a further two-and-a-half years to write it into domestic law. 

New rules on internet sale of medicines

Companies selling medicines over the internet face new rules in future, as regulators seek to clamp down on illegal counterfeit medicines.

EU ambassadors yesterday (21 December) approved an agreement, reached last week by the EU institutions on a regulation intended to protect the legal supply chain of medicines. The new rules mean that a seller of medicines over the internet will have to register with authorities in his home country and ensure that the products being marketed are licensed for sale in another country.

The European Parliament succeeded in ensuring that the internet was part of the legislation. Marisa Matias, the Portuguese left-wing MEP, who led negotiations on the proposal, said in a statement that she was satisfied with the outcome: “The absence of a legal framework encourages not only counterfeiting but also counterfeiters, who are organised in highly profitable criminal networks.”

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