Services

Entering a foreign market is a strategic and a growth decision. In order to reduce the risks COMM-OP EUROPE can offer you a road map for your future successful business and a structure and location as your affiliate. COMM-OP EUROPE will analyse your portfolio and will give you decision support for a business plan and strategy to grow successfully.

Business Operation

Any foreign company with headquarters and business operations outside of Germany can establish a fully owned subsidiary or partner with a local company.

Which of the models would be the right step depends on the headquarters strategy and vision for the future. In order to establish a daughter company with motivated personnel COMM-OP EUROPE can offer you a company setting with personnel, that you can start your business short term. This will reduce significantly the financial investment, labour responsibility and the time hurdle. On the other side motivated and experienced personnel can introduce the product(s) in an existing network of business contacts, KOLs, payers and an established distribution setting.

Personnel

A successful business can be only built up on highly motivated and competent team. Firstly, we can offer you our experienced personnel to establish the Business Operation under the internal lead of COMM-OP EUROPE but under your name.

As soon as the business is running smoothly, we can offer our network of specialised human service companies, to find the right people for you in your branch.

Start-up

As it might be to us to fulfill the set expectations by setting up for you a daughter company, you can rely on a sustainable business scenario.

In such a Business Operation we offer you experienced personnel from Scientific Support and Medical, Regulatory and Pharmacovigilance as well as Legal and Accounting/Tax. Professional Project manager handle all the necessary steps.

COMM-OP EUROPE Consulting Service is available from defining the appropriate Legal Entity, to Public Relation and Governmental Affairs, national and European wide.

COMM-OP EUROPE offers a broad network of Experts, which can support you tailor-made from Clinical Development to Sales.

Your unique exchange with Science and Payers in Advisory Boards at early stage can give you an excellent insight and helps you to define the strategy for a successful business.

Start-up Coaching

COMM-OP EUROPE offers Start-ups in Life Science Consultancy and Coaching, which shall help to overcome pitfalls and become more efficient. It shall ensure that highly motivated entrepreneurs, can concentrate on their assets and are supported in developing the young company.

Within the existing network, COMM-OP EUROPE can help to find the right established partners/companies in the different stages of Development or Market Access.

Considering private and public Venture Capital or Funding at the earliest time helps to establish a successful company before the private cash is spent.

As an innovative approach, COMM-OP EUROPE offers Business Mentoring for 12 months period, so the start-up team can challenge their business model, adopt to leadership and excellence. This will increase professionalism and put the focus on vital targets for sustainable business.

Clinical Development

You have a product in development, which shall be launched also in Germany/Europe?

After the USA, Germany is in second position, in Europe No. 1 for clinical research. Entrepreneurs find a broad scientific landscape with many university hospitals and funding by different leading non-governmental and non-profit-organisations, e.g. German Cancer Aid (Deutsche Krebshilfe) for investigator initiated trials.

In order to achieve a first assessment of your product by the scientific community, we are specialized in establishing Advisory Boards by science, payers and institutions.

This gives the opportunity to initiate the first contacts to your future investigators and prescribers or/and to prepare for Early Access Programmes.

We can assist you to find the right CRO, the appropriate Key Opinion Leaders for Advisory Boards and Clinical Trials to establish your Clinical Development in your targeted market.

Market Access

You have a product and want to enter the German / European Market?

To start with Germany is the right entrance for all the European Markets in order to establish a sustainable pricing and reimbursement strategy.

We support you in your Development Strategies from Clinical, Market Access, Regulatory starting from strategic advice to positioning and pricing. This enables you quickly to start your Commercial Operations in Germany, Austria, UK, BeneLux and Switzerland.

Market Entry

You want to enter the German market with a new Pharmaceutical?

Due to the AMNOG legislation process, you might need to prepare a value dossier in advance before entering the German market since with the registration at the LAUER TAXE (German Pricing System) you initiate the deadlines for a benefit assessment, which affects your pricing widely within Europe.

In order to decide for the best strategy, the size and type of dossier (and so the financial investment), the active ingredient and the future patients have to be carefully evaluated in advance.

COMM-OP EUROPE Europe will assist you in this process and find the best cost-effective strategy.

Reimbursement

In the European Union prices and reimbursement levels for medicines are a national competence dealt with by each EU Member State on a national or regional level.

In the German health care system, for a long time manufacturers were effectively free to determine the reimbursement price of patented drugs.

In recent years, however, pricing and reimbursement in Germany has been modified. In January 2011 a new system was introduced to determine the reimbursement prices of new active substances entering the German market. This new system, known as the “AMNOG-System” foresees a 2-step procedure which new medicines have to undergo as soon as they enter the German market. This procedure takes about a year to be finalised. During this first year in the German market manufacturers of new innovative pharmaceuticals can freely determine the reimbursement price of their products (however, a mandatory rebate of 7% applies).

The first step of the AMNOG procedure is an assessment of the drugs’ benefit (so called “additional benefit”) compared to an established therapy for the same indication (so called “comparator therapy”). The result of this evaluation is the basis for the second step of the procedures, requiring the manufacturer to negotiate the reimbursement price with representatives of the German statutory health insurance funds.

The results of the pharmaceutical’s benefit assessment directly influence the outcome of the negotiations. In particular, in case no additional benefit is acknowledged in the assessment, the negotiating parties do not have any discretion on determining the price. In these cases the product will be reimbursed at the same rate as the product it has been compared with in the assessment. In case the price negotiations fail a mandatory arbitration procedure is foreseen during which an arbitration board will determine the reimbursement price.

According to the law members have are entitled to a sufficient, appropriate and economic standard of health care. The actual extent of health services covered (so called “Leistungskatalog”) is determined by the GBA (Gemeinsamer Bundesausschuss – Federal Joint Committee).

The GBA is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. The GBA also plays the leading role in the HTA-assessment of new active substances in the so called AMNOG procedures and is therefore an institution of major significance for pharmaceutical manufacturers.

The extent of health care services covered by the GKV includes generally the standard-of-care therapy for every illness (including severe and rare diseases) and certain health prevention and screening measures.

The scope of health services determined by the GBA applies uniformly to all GKVs. Therefore every person insured in the GKV receives the same level of health care regardless of the health insurances he or she has individually chosen.

Funding of the statutory health funds

The GKV funds are mostly financed by contributions that are paid partly by the members (insured) and partly by their employers. The contributions are collected by the funds but are fully transferred to a specific public health fund (“Gesundheitsfonds”). This fund also receives a fixed contribution from the federal budget.

The fund’s revenue is then assigned to the insurances according to rules determined by law.

Read more on www.mapbiopharma.com/germany/.