Turning point for the pharmaceutical industry

- Coalition Agreements and Their Consequences for the Industry
- Hope Bearer Biopharmaceuticals
- Patent Expirations – End or Beginning of a Success Story?

It is gradually becoming clear what pharmaceutical manufacturers need to prepare for in the new legislative period: The mandatory discount for medicines, which according to law was to decrease from 16 to six percent starting in 2014, is currently being negotiated by the Federal Health Committee and will be set at seven percent, remaining in effect until 2017.

The price moratorium will also continue according to the plans of the negotiators. In contrast, CDU and SPD representatives announced the end of benefit assessments for established medicines. More than 120 pharmaceutical experts discussed these political decisions, as well as new strategies and approaches, at the 19th Handelsblatt Annual Conference "Pharma 2014" in Frankfurt am Main. At Germany's largest strategic meeting of the pharmaceutical industry, drug manufacturers presented their current business models, shared their experiences with AMNOG, and examined developments in the international pharmaceutical market.

Hope Bearer Biopharmaceuticals

Industry experts and investors again expected higher sales revenues for the pharmaceutical industry in 2014. The sector of biopharmaceuticals was expected to contribute to this, which market observer IMS Health already regarded as a significant growth factor in the pharmaceutical market. Currently, around 23 percent of statutory health insurance (GKV) expenditures are allocated to this area, according to IMS Health. For Christophe Bourdon, the new Germany head of biotech company AMGEN and speaker at the Handelsblatt conference, biotechnology is the great hope in medicine. "The entire European healthcare market is currently undergoing change, and everyone is looking to Germany," Bourdon said at his inauguration. "One of the major tasks will be to clearly demonstrate the value of this young science and our new therapeutic approaches."

Patent Expirations – Turning Point in the Pharmaceutical Sector?

Recently, generic manufacturers have been gaining more and more market share from brand-name companies. Their sales have grown faster than those of original manufacturers. However, their rise is gradually coming to a halt: Given the good figures and forecasts of original manufacturers, Handelsblatt already spoke of a turning point. (HB 23.10.2013) Whether patent expirations mark the end or the beginning of a success story was discussed at the pharmaceutical conference by Dr. Markus Leyck Dieken, managing director of Teva Germany. The company produces both innovative medicines and generic products.

Experiences After Three Years of AMNOG

The consequences of the AMNOG pharmaceutical reform and the early benefit assessment of new active substances were examined from different perspectives at the event: Prof. Dr. Walter Schwerdtfeger, President of the Federal Institute for Drugs and Medical Devices (BfArM), presented his agency's role in the evaluation process, while companies like GlaxoSmithKline and AstraZeneca showed how they manage the early benefit assessment of their products. "The benefit assessment has been scrutinized by the new federal government, especially regarding the existing market. Independent of this, a European-wide perspective is still missing. The effort associated with benefit assessments for the pharmaceutical industry suggests a need for a pan-European view," explained Dr. Wolfgang Rehmann, partner at the law firm Taylor Wessing. The lawyer provided a critical discussion of benefit assessments within the context of the EU internal market.

The conference also highlighted global perspectives: Merck Serono Germany’s new CEO, Belén Garijo, provided insights into her company's international activities. Additionally, experts like Dr. Alric Rüther from the Institute for Quality and Efficiency in Health Care (IQWiG) and Prof. Stephen Palmer from the NICE Technology Appraisal Committee discussed and compared European assessment processes (HTA) during the separately bookable "International Pharma Day".