Public Law and Tax Litigation
The multi-disciplinary legal pharmaco-economic team offers you its exclusive know-how in all principal areas of the pharmaceutical industry. Numerous members of the team have years of experience from the Ministry of Health and the State Institute for Drug Control. We specialise primarily in the price and payment regulation of pharmaceuticals and healthcare devices, advertising regulation, regulatory compliance, market access and legal relations between payers and healthcare service providers.
How we can help you:
- Analyse the position of pharmaceutical on the market and analyse potential competitors before the launch to market and business strategy.
- Analyse groups of pharmaceuticals in terms of payments from public health insurance, monitor in-depth and shortened reviews, analyse the prescription and conditions of payments, monitor the development in management and assessment for the process strategy of the participant in the proceedings, or post-review business strategy.
- Provide consultations in the area of prices and payments for pharmaceuticals and medical devices, namely consultations prior to filing the application for the determination or change in the maximum price or payment from the public health insurance, including the pharmaco-economics, and completion of the application; representation in administrative proceedings, including an appellate body/court.
- Provide comprehensive advisory in marketing and advertising (including the assessment of compliance with legal regulations or codes of ethics), relation between a producer and health insurers, professional associations, physicians, patients, business partners, etc.
- Represent your company in administrative proceedings initiated according to the Act on Advertising Regulation and the Act on Pharmaceuticals (eg, administrative torts, proceedings on the application for an extraordinary remedy, specific treatment programme, proceedings on determining the nature of products in case of doubt), including the appellate body/court.
- Provide regulatory compliance advisory, including assistance in internal and external audit reviews in the area of adherence to (legal, internal or ethical) rules, regulating the pharma industry.
- Correctly classify the product in legally regulated categories of medicinal products, medical devices, cosmetics, food supplements, etc. and advisory in follow-up activities, for example the method of the launch to market, registration/notification, advertising strategy, umbrella branding, etc.
- Provide advisory services in the area of good clinical, manufacturing, distribution or pharmaceutical practice (GCP, GMP, GDP, GPP), including a review or cooperation on the preparation of necessary documentation.
- Provide comprehensive services for pharmacies and distributors ranging from the registration to post-registration representation in relation to supervisory activities of administrative bodies (administrative torts, reporting obligations, etc.).
We represent our clients in tax reviews and before the courts and advise on how to avoid tax litigations. We do not promise the impossible and together we shall find a solution arising from a realistic analysis of the situation.
We closely cooperate with Deloitte tax advisors in interpreting material tax law. We watch and co-create the latest judicature approaches to the resolution of tax litigations.
We provide recommendations in setting-up company processes in order to prevent new disputes and protect a management liability.
How we can help you:
Do not be on your own when a review comes
- Practical assistance in tax reviews so that you do not miss a chance to protect your rights.
- Protection in cases where a tax administrator acts in conflict with its obligations and your rights.
If going to court, then always with a professional help
- Representation before regional courts and the Supreme Administrative Court.
- Strategic litigations where others did not succeed.
Protection against being involved in a carousel fraud
- Review and set-up of company’s processes as protection against involvement in the frauds of others.
Compensation for damage
- Enforcement of interest from detentioned excess of VAT.
- Enforcement of the compensation for damage caused by illegal action of the state.
We provide both contracting entities and our contractors with comprehensive legal advisory. Services include, but are not limited to, the preparation of procurement specifications, assessment of offers (tenders) presented by tenderers, representation of both contracting entities and tenderers at the Office for the Protection of Competition and administrative courts, advisory relating to tender preparation, analysis processing, etc.
How we can help you:
1. Services for public, sector and subsidised contracting entities
- Drafting or review of tender conditions.
- Drafting and review of internal guidelines.
- Audit of public contract award system.
- Representation of a contracting entity in tender proceedings before the Office for the Protection of Competition or administrative courts.
2. Services for tenderers
- Legal assistance with the preparation of tender proposal in tender proceedings, final assessment of its correctness and completeness.
- Representation in tender proceedings, eg, in dealing with negotiated procedures.
- Preparation of objections against the actions of a contracting entity damaging the interests of the tenderer.
- Representation in the proceedings before the Office for the Protection of Competition or before administrative courts.
3. Other services both for contracting entities and tenderers
- Impact analysis of new regulation related to public procurement focusing on the client’s needs, training of involved employees.
- Implementation of a new act on public procurement into internal procedures.
Contrary to the previous marginal focus on the regulation of the environment, in these days this regulation influences the operation and sustainability of the entirety of business branches. This rapidly developing regulation of business is, to a large extent, accepted on the EU level and is either a result of the failure of companies in managing their impact on the surrounding area or, on the other hand, it is connected to their successful programmes and extends the application of originally voluntary standards to the whole economic sectors. This regulation is particularly prone to a massive breach by companies that are usually all the more surprised by extraordinarily high penalties.
How we can help you:
- Environmental due diligences of own or purchased companies.
- Waste management and extended responsibility of producers (product take-back).
- Trading with greenhouse gas emission permits.
- Use of chemical substances (REACH).
- Integrated prevention and limitation of pollution.
- Consideration of the effects of construction projects on public health and the environment.
- Disposal of genetically modified organisms and genetic products.
- Aid for the production of electricity from renewable resources.
- Responsibility for environmental damages.
- Creating legislation in the field of the environment and evaluating their impact.
- Implementation of the sustainability strategy of companies.
The services are often provided as part of a wider, eg, transaction, subsidy or strategic, consultancy and in project teams under the attendance of Deloitte technical engineers and advisors.