BERLIN, July 12 (APM) - The German government and Parliament should take back control on drug assessment and pricing policy, German pharmaceutical lobby vfa said on Wednesday.
Payers have taken control of these policies and have acted as "substitute legislator" because the government and the Bundestag have failed to act, said vfa managing director Birgit Fischer in a press statement.
Vfa recommended "fundamental changes" in the health technology assessment (HTA) and pricing procedures by ousting the umbrella payer group GKV-Spitzenverband (GKV-SV) from the assessment procedure, in a June position paper presenting its demands for the next general election on September 24 (APMMA 53513).
Vfa also recommends enhancing the role of regulatory bodies, medical societies and patients in the assessment procedure.
For the HTA body G-BA, which is the highest decision-making body of the self-government in the German healthcare system, payers "control the procedure", Fischer said.
The most visible consequence of the payers' influence is that "one fifth of new drugs have been withdrawn from the German market" after the HTA procedure. Vfa emphasised that some of the withdrawn drugs are recommended in medical guidelines but they are not taken into account.
"This shows that the pendulum is too much in the direction of short-sighted savings" and not enough on the quality of care, Fischer said.
The Parliament has "frequently missed opportunities" to settle pending issues, Fischer said.
"Many questions have remained unanswered and open, such as the so-called mixed price. Other questions have been regulated by the legislator only seemingly and with a vague way, as with the doctor information system".
Fischer referred to the last changes made to the AMNOG drug law in the drugs care reinforcement law (AM-VSG), which came into force in May (APMMA 53072).
The government initially planned to introduce two key measures in this law, a 250 million-euro volume pricing threshold to limit high drug prices, and confidentiality on reimbursed prices, requested by the pharma industry, but they were removed at the last minute because of lack of political compromise (APMMA 52120).
The pharma lobby has called for clarification of legal framework in the 'mixed price' system, regarding the pricing of products found to have different levels of benefit in different patient subgroups, after a court put into question its legal basis (APMMA 53724).
The AM-VSG provides for a new doctor information system (AIS) which will allow physicians to access the G-BA's rulings on added benefit assessment of a new drug using their practice software. Practical details will be provided in a regulation prepared by the G-BA and expected to be published before the end of 2017 (APMMA 52375).
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