Terugbetalingssystemen voor geneesmiddelen ... - Pharma

40 Drug Reimbursement Systems KCE Reports 147
3.1.1 Transparency
All drug reimbursement systems included in our study underwent major reforms as
response to rapidly increasing pharmaceutical expenditures and addressing the
requirements of the European Transparency Directive in 1989. 48l The Directive was
issued on the initiative of Directorate General Enterprise and Industry out of concern
over potential distortions of intra-Community trade in medicinal products which may
be caused by national measures controlling public health expenditure. The objective of
the Directive was to enable interested parties to verify that national pricing and
reimbursement decisions do not impinge on pharmaceutical trade within the European
Union. 49 This should be obtained by ensuring transparency of the national procedures
for drug pricing and reimbursement towards the pharmaceutical industry. Besides
defining the timeframe within which decisions about pricing and reimbursement must be
taken, the Directive states that:
• Negative decisions must be communicated to the applicant and contain a
statement of reasons based on objective and verifiable criteria;
• decisions must be open to judicial appeal at national level.
One might think that the transparency requested is closely related to the transparency
requested by the accountability for reasonableness framework, but this is incorrect. The
type of transparency imposed by the Transparency Directive is largely insufficient to
ensure accountability for reasonableness.
• Firstly, the Directive only requires that motivations for the negative decisions
are communicated to the applicant (i.e. the manufacturer asking for
reimbursement), not for the positive decisions and not to the general public.
This implies that only the agreement between the applicant and the decision
maker seems to matter, while for accountability for reasonableness the vision
of all relevant stakeholders matters.
• Secondly, the decisions should be based on “objective and verifiable criteria”.
However, criteria used in a drug reimbursement request –even if explicit–
are rarely fully objective and verifiable, nor is their relationship with the
actual decision. For example, the added therapeutic value of a drug can be
measured in terms of an objective outcome parameter (e.g. number of life
years gained compared to the alternative). The value and the weight given to
this element in the final decision is, however, neither objective nor verifiable.
Although this is a general issue, applying to the entire drug reimbursement
decision process and thus to this entire report, we highlight it here because it
is a requirement imposed by the Transparency Directive that cannot be
sufficiently satisfied.
In conclusion, although the European Transparency Directive has increased the
transparency of the drug reimbursement decision process to some extent, it cannot
ensure the kind of transparency required for accountability for reasonableness because
of the main focus on the transparency towards the applicant only and not towards the
general public.
Our comparison showed that all countries but Austria publish at least the assessment
reports. However, the extensiveness of information on the assessment varies between
countries. The appraisal process, leading to the advice, and/or the decision process, is
rarely made public, although variations were found between countries. Noteworthy is
that in Sweden manufacturers can withdraw their case before the final reimbursement
decision has been made in which case no report is published. Although this might
guarantee confidentiality, it is at the cost of transparency.
l
Council Directive 89/105/EEC of 21 December 1989 relating to the transparency of measures regulating
the pricing of medicinal products for human use and their inclusion within the scope of national health
insurance systems. (http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/pricingreimbursement/transparency/index_en.htm)