Wednesday, February 23, 2011

European Parliament to streamline prescription drug supply

The European Parliament has approved measures which should help streamline orders and supply of prescription drugs to pharmacies.

The plans, which will see changes to medicine packaging, will go some way towards cracking down on counterfeit drugs.

As part of the move, drug packets could be given electronic serialisation numbers, which would allow pharmacies to check the drug's authenticity.

The plans, rubber-stamped by MEPs this week, will also widen European regulation over online medicine sales. Plans are in place to give European internet pharmacies a common, recognisable logo.

The National Pharmacy Association (NPA) has called for the changes to be brought into force "in an efficient and non-bureaucratic way."

Raj Patel, NPA board member and head of the UK delegation to the Pharmaceutical Group of the European Union (PGEU), added: "This is one of the most significant European directives for community pharmacy that we have ever seen and its impact will be felt by pharmacists working across the EU."


Tuesday, February 01, 2011

Patients' Rights in Cross-Border Healthcare

An elderly German man with diabetes brings extra prescriptions with him on a trip to Italy but will the pharmacist accept the prescription? A Polish woman would like to receive hip surgery in the country where her grandchildren live and work but how can she organise this from Poland? A Portuguese man seeks cataract surgery from a specialist in Spain but will he be reimbursed? These are just a couple of cases where a patient may need clarity on rights and rules for cross-border healthcare.

A newly adopted EU law clarifies patients' rights to access safe and good quality treatment across EU borders, and be reimbursed for it. Patients travelling to another EU country for medical care will enjoy equal treatment with the citizens of the country in which they are treated. This new law will benefit EU patients in several other ways. It will make it easier for national health authorities to work closer together and exchange information on quality and safety standards of healthcare. It will help patients who need specialised treatment, for example those who are seeking diagnosis or treatment for a rare disease. It supports the development of "European Reference Networks" bringing together, on a voluntary basis, specialised centres of expertise already recognised in Europe. Health experts across Europe will be able to share best practices on healthcare and provide standards of excellence.
What scale are we talking about?
Patients prefer to receive healthcare in their own country. That is why the demand for cross-border healthcare represents only around 1% of public spending on healthcare, which is currently around €10 billion. This estimate includes cross-border healthcare which patients had not planned in advance (such as emergency care). This means less than 1% of the expenditure and movement of patients is for planned cross-border healthcare, like hip and knee operations or cataract surgery.
What about the existing legislation in this area (Regulations on social security)?
Citizens needing care (including emergency care) when temporarily abroad will continue to benefit from the existing Regulations scheme and be provided with the care they need.
For planned care, a patient can already apply for prior authorisation. This cannot be refused if he/she cannot be treated within a time limit which is medically justifiable.
Why do we need this new legislation then?
This Directive will not affect the benefits already offered to citizens through existing Regulations on social security. Although the existing rules – which focus on social security agreements, not on patients' rights - have been in place since 1971, clarification was still needed on the rights of EU citizens to receive healthcare in another Member State.
In the case of hospital care, one of the main achievements of this new Directive is that patients will be able to choose their healthcare provider.
For non-hospital care, patients will be able to seek healthcare abroad without prior authorisation or formalities, and claim reimbursement upon their return home. This Directive covers not only public, but also private providers.
For both hospital and non-hospital care, patients will have access to information on the quality and safety of the care they will receive.
This Directive also seeks to address other practical questions: where can I find information on quality standards applied by the hospital? How much will I be reimbursed? The European Court of Justice has confirmed1 that the right to seek cross-border healthcare already exists in the Treaty. However, this newly adopted Directive sets this out clearly in EU law and provides a uniform and coherent framework for all citizens in Europe.
Do I need authorisation from my national authority before going abroad for treatment?
National authorities can introduce a system of "prior authorisation" in 3 cases:
1) For healthcare which involves overnight hospital stay of at least one night;
2) for highly specialised and cost-intensive healthcare;
3) in serious and specific cases relating to the quality or safety the care provided abroad. In these 3 cases, patients may need to ask for permission in advance from their national health authority in charge of reimbursement.
Can this authorisation be refused?
National health authorities can refuse authorisation if the treatment in question, or the healthcare provider in question, could present a risk for the patient. Also, if appropriate healthcare can be provided at home in good time, authorisation can be refused but Member States will need to explain why such a decision is necessary.
What if I am refused authorisation?
Patients have the right to request a review of any administrative decision on cross-border healthcare for their individual case.
How much will I be reimbursed after receiving a treatment abroad?
Patients will be reimbursed the same amount as they would receive in their own country for the same type of healthcare. Member States where care is free of charge will need to inform patients about their reimbursement tariffs.
1 Kohll and Decker (1998); Ferlini (2000); Geraets-Smits and Peerbooms (2001); Vanbraekel (2001); Inizan (2003); Müller Fauré and Van Riet (2003); Leichtle (2004); Watts (2006); Stamatelaki (2007); Elchinov (2010).