Expect change in Germany: Pharma Dialogue gives industry hope

Germany's government has set up a series of workshops, called the "Pharma Dialogue", which give the native pharma industry a platform for the next year from which to share its victories and air its grievances. Many are hoping to see legislative changes as a result of the dialogue sessions that favor industry more than Germany's most recent tweaks.

The idea is to present an official platform for pharma and the government to exchange ideas about what is going well, where there are problems, and the issues industry faces in Germany. The sessions will be attended by representatives from industry associations including the vfa, the BPI, BioDeutschland, the BAH and ProGenerika; and representatives from Germany's health ministry, the ministry for research and education, and the ministry for economic affairs. In addition, there will be representatives from academia, and the trade union for Mining, Chemical and Energy (IG BCE).

The Pharma Dialogue officially kicked off on 15 September 2014, but the first of the four scheduled dialogue sessions took place 21 January 2015. The initiative is set to run until early 2016 (see table below for timeline and details on the topics to be discussed), and industry is hopeful that suggestions from the Pharma Dialogue will be incorporated into legislation either late in 2015 or early 2016.

Oliver Sude, legal counsel at EUCOPE (European Confederation of Pharmaceutical Entrepreneurs), said that while the Pharma Dialogue was not set up with the intention of creating legislative change, and nor is change dependent on the outcomes of the Pharma Dialogue, it is nevertheless tacitly understood that this will be the end result. "Everyone is expecting that there will be changes within the next 16-18 months or so," he said.

As for what pharma would request from the German government, that remains to be seen. However, there are certain obvious pain points, particularly when it comes to pricing and reimbursement. The last round of legislative change included an extended price freeze, and mandatory rebates of 7% (scripintelligence.com, 19 December 2013). "I think naturally industry hopes these two cost-containment measures will not be part of the new legislative project in the future," said Dr Sude.

In addition, it is likely that industry will call for greater transparency in the early benefit assessment system. In particular, the pharma associations have regularly complained about the fact that the statutory health insurers with whom companies negotiate their prices is represented as part of the G-BA, the regulatory body that runs the early benefit assessment. It is has been perceived that this skews things in favor of the health insurers, since industry is not represented in the same way.

Positive step

Whatever the outcomes of the Pharma Dialogue, industry has welcomed the opportunity to have discussions with the German government on a fair playing field. Dr Sude said it was a positive sign that so many ministries were involved, allowing more government perspectives to be heard than just that of the payers.

He added, "I think it is important to have an official way to voice your concerns, but also to explain what is going well, the best practices the industry is encountering, and also the best practices from other member states, and to explain it to the German government."

While industry has faced many challenges in Germany over recent years while the government overhauled its pricing and reimbursement policy, scrapping the free trade system that pharma had long enjoyed, the Pharma Dialogue is a sign that the government is willing to acknowledge that and work to change it. "I think the government values the pharmaceutical industry in terms of the economic impact, in terms of what they're doing to keep Germany an attractive place for research and development," said Dr Sude.

Timeline for Pharma Dialogue sessions

Source: EUCOPE

Date	Event	Topics for discussion
15 September 2014	Kick-off event	Presentation on "Pharmaceuticals in Germany" from the viewpoint of science and the pharmaceutical industry respectively (followed by discussion). The manufacturers' associations, together with the IG BCE, prepared a joint paper stating that the following aspects should be addressed in the Pharma Dialogue: Commitment to the importance of a multi-faceted, high-capacity pharmaceutical industry for care, research and production; The economic significance of pharma in Germany; and The benefits for society as a whole of the pharmaceutical industry for the health and prosperity of Germany, against the background of new social developments.
21 January 2015	First Pharma Dialogue session	1. Value chain – from idea to product Picture of the value chain, from research and development to application to a concrete example, such as antibiotics; Opportunities to support research and development and business growth, taking into account the availability of venture capital; Start-up support, success factors and successful start-ups; Conditions for spin-offs; Importance of small and medium-sized enterprises. 2. Framework conditions and Research Funding Importance of Germany as a location for research; Status quo of funding structures; Networking between preclinical (academic) research and pharmaceutical production; Outsourcing into clinical research- and development programs; Drug discovery; Opportunities to support research and development in the academic environment; Financing of start-up and growth financing; Exploration and production of critical care drugs and medicines
3 June 2015	Second Pharma Dialogue session	Regulatory framework: Market access and reimbursement system, ensuring predictability; Securing access to innovation in new and established drugs; Ratio of admission and benefit assessment; Experience with the early benefit assessment; Framework for further development of drugs based on existing active ingredients; Impact of modified competition and health policies on business models of pharmaceutical companies; Implications for workers and employment; Supply shortages; Implementation of the new EU regulation on clinical trials; Personalized medicine
8 October 2015	Third Pharma Dialogue session	Trends and future areas in the pharmaceutical and pharmaceutical sector: Future of the pharmaceutical industry "Pharma 2025"; Impact of genetic testing on drug therapy and production; New forms of administration; Intellectual property and patent protection; Involvement of pharmaceutical companies in new models of care / impact of digitization on research and development; Employment situation: shortage of skilled labor, age-appropriate employment; Financing of start-up and growth financing
To be confirmed	Fourth Pharma Dialogue session	Summary of the results of the previous three dialogue sessions. Structuring of the results.
January/February 2016	Closing event	Results of the dialogue will be presented.