Cross border pharmacies
In the Netherlands, some pharmacies provide prescription medicines to people who live in other EU member states. Those pharmacies typically use mail-order services to deliver the prescribed medicines. These cross border pharmacies are also providing care across national boundaries.
The Dutch Health and Youth Care Inspectorate (IGJ) checks whether pharmacies are providing a good level of care. This is based on Dutch legislation and professional standards. A problem is that cross border pharmacies are not always able to comply with Dutch legislation and/or professional standards. This is because the healthcare regulations in other EU member states differ. It may be difficult for cross border pharmacies to comply with the Dutch regulations and the regulations in the country that their patients are residents in at the same time.
Exception resulting from European regulations
Within the EU it must be possible to offer goods and services freely across national borders, with no restrictions on trade. However, the assurance of the quality requirements that apply to supplying medicines is not handled the same way in all countries. For that reason, an exception to the usual policy applies in the case of cross border pharmacies.
How does the IGJ supervise cross border pharmacies?
For all public pharmacies, the IGJ checks the quality of the pharmaceutical care delivered against the Medicines Act and the Dutch legally defined standard of ‘good care’. The content of that standard is provided by Dutch standards from the professions and the field. During its inspections of cross border pharmacies, the inspectorate allows certain deviations from the legal Dutch standards.
Strict conditions are imposed in allowing these deviations:
The cross border pharmacy only supplies prescribed medicines to patients who live in another EU member state.
The cross border pharmacy cannot comply to the Dutch legislation, guidelines and procedures because of compliance to the legislation of the EU member state that the patient lives in.
The cross border pharmacy complies to the legislation, guidelines and procedures of the EU member state that the patient lives in and provides a written statement to that effect to the IGJ. This declaration is issued by the competent authority of the country that the patient lives in. A competent authority is e.g. an inspectorate or a ministry.
When does the IGJ take action?
If the cross border pharmacy is unable to present a written declaration when asked to do so, that states that it complies to the legislation, guidelines and procedures in the country that the patient lives in, the IGJ will check the pharmacy against the Dutch standards. If the cross border pharmacy does not comply with these standards, the inspectorate will take action. In that case, the IGJ finds that there is insufficient assurance that good care is being provided.