The final full meeting in the German government's "Pharma Dialogue" took place on 21 January, and the government will present a report on the process in April, with regulatory changes coming out of the process likely to follow.
IHS Life Sciences perspective | |
Implications | Opposite positions have been taken by the statutory health insurance funds and the innovative pharmaceutical industry with regards to the regulatory changes required, particularly the changes to the AMNOG law. |
Outlook | The most likely outcome is a compromise in which the government seeks to make concessions to both sides, meaning that some regulatory changes negative to the pharmaceutical industry are likely to occur in the coming year. |
Final full meeting of "Pharma Dialogue"
The fourth and final full session of the "Pharma Dialogue" – a series of meetings between the pharmaceutical industry and Germany's coalition government, initiated as part of the coalition agreement following the September 2013 general election – took place on 21 January. A report on the conclusions of the process will now be presented at its last meeting on 12 April, reports Deutsche Apotheker Zeitung. As the source reports, during the course of the Pharma Dialogue, representatives of the Federal Ministry of Health (MoH) and several other government ministries met with representatives of the Federal Institute for Drugs and Medical Devices (BfArM), the Paul Ehrlich Institute (Germany's regulatory authority for vaccines and biomedicines), the Federal Joint Committee (G-BA), as well as with representatives of the pharmaceutical industry.
Dialogue process will have a result, although it is unclear what
Deutsche Apotheke Zeitung states that it is sure that the Pharma Dialogue cannot end without any results, and subsequently lists the main issues that are likely to be among the concerns addressed by the government in the report, and consequently likely to be among the issues that may be the subject of regulatory changes in the aftermath of the report. According to the source, the Federal MoH has maintained silence on the subject of the meetings, and has called on other participants to do so as well.
The source implies that one of the most likely issues to be regulated on is the current law that obliges pharmacists to ensure that at least 5% of the reimbursed medicines they dispense are cheaper imports (parallel imports), stipulating that the imports concerned must be at least 15% or EUR15 (USD16.2) cheaper than non-parallel-imported versions. This follows scandals regarding counterfeit medicines discovered that had been parallel-imported into Germany.
Another possible development is the implementation of a list of essential medicines found to be in short supply, to be maintained by BfArM. According to Deutsche Apotheker Zeitung, a meeting is to take place in the near future involving BfArM, the German Federal Pharmacy Chamber, and the German Society of Hospital Pharmacists, at which the issues surrounding the implementation of such a list will be discussed.
Among issues directly affecting the pharmaceutical industry that the source mentions in association with the Pharma Dialogue are the calls from statutory health insurance (GKV) funds for the reimbursement price of new innovative drugs, negotiated following an early benefit assessment, to be imposed retroactively, denying producers the year's free pricing they currently have. Pharmaceutical producers are also keen to remove the "generic price anchor" at the stage of reimbursement-price negotiations, and have also been eager to discuss the issue of the confidentiality of reimbursement prices.
Doctors concerned about high-priced patented drugs
In connection with the conclusion of the Pharma Dialogue, the online news services of Bavarian public-service broadcaster Bayerische Rundfunk reports that GKV funds and some doctors are united in their concern about the trend of increasing prices of new innovative drugs. The source mentions the Gilead Sciences (US) hepatitis C virus drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir + ledipasvir), and quotes Professor Georg Marckmann, of the institute of medical ethics, history and theory at Munich's Ludwig-Maximilian University, claiming that pharmaceutical companies' pricing policies reduce the chance of patients' recovering, and even put patients' lives at risk. Additionally, the source quotes the head of the Medicines Commission of the German Medical Association, Professor Wolf-Dieter Ludwig, as saying that Germany's healthcare system simply cannot support the increasingly high prices of patented drugs – which also include new cancer drugs.
According to Bayerische Rundfunk, the German government's response to the question of whether it would respond to the warnings over the high prices of patented drugs was that the Pharma Dialogue was ending and the situation would be assessed again after its conclusion.
Outlook and implications
For more than a year, there have been regular interventions from GKV funds and other stakeholders on one side of the argument, arguing for changes to the Pharmaceutical Market Restructuring Act (AMNOG) that would curb the rise in public spending on pharmaceuticals, and from the innovative pharmaceutical industry on the other, arguing that the current form of AMNOG is already restrictive with regards to the assessment of innovative medicines. After a rise of more than 10% year on year (y/y) in GKV expenditure on reimbursed drugs, a report from late January by the German Pharmacists' Association indicates that this spending rose by 5% y/y in 2015. The majority of the 5% difference between spending in 2014 and 2015 is accounted for by the reduction in the statutory discount on non-reference-priced drugs from 16% at the end of 2013 to 6% from January 2014 and afterwards 7% from April 2014.
Although the Federal MoH has called for confidentiality regarding the Pharma Dialogue, much of what has been discussed has been leaked after previous sessions. The German government finds itself in what could be described as its 'default' position, of needing to support and protect the interests of the pharmaceutical industry in the country, which is very important for Germany's overall economy, and needing to respond to growing general healthcare spending, which also includes the growth in pharmaceutical expenditure. The outcome of the Pharma Dialogue is difficult to predict, although it is likely that the government would look to make concessions to both sides. Therefore, it is unlikely that it would end without some negative implications for the innovative pharmaceutical industry.