How to Foster Pharma Innovation: Belgium’s Pact for the Future 2015

The bio-pharmaceutical industry is characterized by massive investments, long and rigorous product development and great financial risk, where statistically only two out of ten drugs will earn back the money invested into their development It is therefore crucial for investors and the pharma industry that the framework they are operating in is hospitable, stable, and predictable over a duration of time.

In Belgium, in July 2015, the Belgian Minister of Social Affairs and Public Health Maggie De Block signed a “Pact for the Future” (Toekomstpact 2015) with the CEO of pharma.be Catherine Rutten and the delegated manager of FeBelGen.

The latter two signatories belong to umbrella associations representative of the Belgian pharmaceutical industry.

Pharma.be is the General Association of the Medicine Industry, currently counting 140 members of pharma enterprises that are headquartered in Belgium. Pharma.be’s mission is to promote better healthcare through therapeutic innovations, and one of its priorities is to facilitate quick access to new drugs.

The other association, FeBelGen, provides tailored advice to its members for the marketing of generic and biosimilar medicine. Its services are specialized in registration, pricing and reimbursement processes for specific generic and biosimilar drugs.

The Pact for the Future that was signed has three key pillars:

  • an improved access to medication for the patient,
  • fostering innovation within the industry, and
  • providing a new deontological framework for the sector as a whole.

With the introduction of new fiscal measures and guidelines -to ensure that pharma remains financially sustainable as well as incentivized to innovate, whilst improving patient access to drugs- the following numbers have been produced:

  • The taxes on profit for Belgian pharmaceutical companies is reduced from 7.73 percent to 6.73 percent; a decrease of 13 percent
  • The agreement entails 126 m Euro additional savings, 80 percent of which shall be carried by the pharma corporations
  • The collective patient population will save 60 m Euro in 2018; in overall structural terms the patient bill will be reduced over 50 m Euro
  • A further price reduction of generic medicine and medicine that is no longer patented, allowing the additionally saved funds to enable the access to innovative medications for patients two months earlier
  • The maximal patient copayment for a prescription medicine will be restricted to five Euro instead of the current 10.8 Euro

Regulation was revised to stimulate pharmaceutical spending and innovation:

  • Reimbursements in the frame of article 81 contracts shall be exempt from sales tax
  • The Ministry will investigate whether the reimbursements above a certain limit, for example 30 million, can be deducted from the clawback, in the frame of article 81 contracts
  • In consultation with the Ministry of Finance, the Ministry of Social Affairs will investigate within the framework of the bio-pharma platform whether a biotech tax shelter can be introduced for “early developmental stages” of medicine

To improve transparency, fair competition and deontology, the following will be in effect:

  • The Ministry of Social Affairs will no longer receive companies whilst scientific and evaluation procedures are ongoing.
  • All results from clinical trials will be published on a centralized portal and conflicts of interest will have to be notified beforehand
  • Stricter transparency measures will be imposed by the BeTransparent.be project

The following plans are also set forth in the Pact for the Future:

  • A greater European and international cohesion and collaboration to facilitate greater accessibility to innovative therapies
  • The shortening of several procedures to allow medicine to reach the patient quicker, for example, by risk-sharing agreements on a European and international level
  • Devising a knowledge-system of various patient registers
  • Seeking a solution for unavailable medicine
  • Expanding patient support programs and safeguarding independent and qualitative medicine information
  • Investigating whether the simultaneous reimbursements of predictive tests can be realized prior to a medicinal treatment
  • Speed up the reimbursement for new medication

It is an exciting and promising Pact, a stable basis for further dialogue, and a very positive step towards the creation of sustainable and collaborative framework that fosters the symbiotic nature of state and industry.

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About Laura Weynants

Performs primary and secondary market research to create country reports at TforG. Interviews KOLs and medical sector professionals to build on TforG’s healthcare market expertise and competence networks. Complementing five years of sustainability policy and CSR communication, she now focuses on grasping key medical market trends, structures and opportunities in medical sectors worldwide. Coming from an international background of living in Germany, Spain, USA, UK and Belgium, she has gained a keen insight in international organizations and language skills to perform first hand investigations. She graduated from Sussex University Brighton, UK with a BA English Literature and Sociology and achieved a Master Degree in Sustainability and Corporate Social Responsibility in EOI Business School in Madrid, Spain.