Practice area · Nationwide coverage
Energy, hydrocarbons, telecommunications, transport, healthcare, pharma, food and industry. Defence before the CNMC, AEMPS, AESAN and regional regulators. Preventive advice and litigation when sanctioning proceedings leave no room for delay.
Companies operating in regulated sectors don't just compete in the market: they also compete with the regulatory framework. An expired authorisation, a poorly handled inspection procedure, or a sanctioning file without proper defence can halt operations, jeopardise the operating licence, or lead to penalties that in some sectors reach 10% of annual turnover.
In Spain, regulated sectors are subject to a triple regulatory layer: State sector legislation (Law 24/2013, Law 34/1998, Law 11/2022, Law 21/1992), directly applicable European law (MDR, IVDR, Regulation 1169/2011, the Green Taxonomy), and regional regulation on industrial activity, health and energy. Three fronts that require up-to-date knowledge and an active stance.
Dobarro y Asociados advises companies in four regulated sectors under three service models: a monthly regulatory compliance retainer, ad hoc defence in sanctioning proceedings, and strategic litigation before regulators and courts.
Sample photo (Regulated Sectors) No. 1
Four specialised sectors
Comprehensive legal coverage in the four most heavily regulated sectors in Spain, with accumulated experience in sanctioning proceedings, access authorisations, and litigation before State and regional regulators.
Energy
Installation authorisations, grid access, energy retailers, CNMC penalties, self-consumption and energy communities. Framework: Law 24/2013 (Electricity Sector), Law 34/1998 (Hydrocarbons), RD 1183/2020 and Law 7/2021 (Climate Change).
Learn more →Telecommunications
Operator authorisations, radio spectrum, access infrastructure and transport concessions. Regulators: CNMC and SETSI (telecommunications), MITMA (land, rail and maritime transport).
Learn more →Healthcare and Pharma
Authorisation of medicines and medical devices (MDR/IVDR Regulation), AEMPS inspections, defence against penalties and market withdrawals, food labelling (AESAN, Regulation 1169/2011), and coordination with the EMA and EFSA.
Learn more →Industry
Industrial activity authorisations, chemical product storage (RD 656/2017 APQ), industrial waste (Law 7/2022), pressure equipment (RD 2060/2008), and defence against penalties from regional industry departments.
Learn more →How we work with regulated clients
For companies needing continuous monitoring of their regulatory compliance. Includes tracking regulatory changes, unlimited queries in the agreed area, periodic review of current authorisations, and alerts for renewal deadlines or new obligations. Pricing is set according to the sector and the volume of regulated activity.
When the company receives an inspection, a report, or the opening of sanctioning proceedings. Immediate action: analysis of the administrative act, an arguments strategy, filing within the legal deadline, and, if the proceedings are not resolved favourably, an administrative appeal and judicial review. Deadlines in sanctioning law are short: don't wait.
M&A in regulated sectors (due diligence on authorisations, concession ownership, change of control), entering new markets (applying for access authorisations), restructurings affecting existing licences, and strategic litigation before the National Court or the Supreme Court. Each transaction is handled by a dedicated team.
Many regulated-sector companies operate in several European or Latin American countries with different regulatory frameworks. Dobarro y Asociados belongs to the Lex Prudens network, allowing regulatory defence to be coordinated across multiple jurisdictions with a single point of contact in Spain. Especially relevant in energy, telecommunications and pharma.
“The CNMC opened sanctioning proceedings against our electricity retailer over an alleged billing breach. Dobarro reviewed the charges, identified a defect in the inspection procedure, and secured the annulment of the proposed penalty before the final decision.”
— Compliance Director, electricity retailer · Spain
A regulated sector is one where economic activity is subject to a specific regulatory regime and the supervision of an independent regulatory body. In Spain, the main regulated sectors are energy (CNMC, Law 24/2013), hydrocarbons (Law 34/1998), telecommunications (CNMC, Law 11/2022), transport (MITMA), healthcare and pharma (AEMPS), food (AESAN) and industry (Law 21/1992). Companies in these sectors must comply with specific administrative authorisations and are exposed to substantial penalties for non-compliance.
Dobarro y Asociados offers three main service models: a monthly retainer for preventive regulatory advice, ad hoc defence in sanctioning proceedings before sector regulators (CNMC, AEMPS, AESAN, regional departments), and litigation before the judicial review courts. For special transactions (M&A, market-entry authorisations, restructurings), it coordinates with specialists from the Lex Prudens network.
Penalties vary by sector. In energy, the CNMC can impose fines of up to 10% of annual turnover. In industry, Law 21/1992 provides for penalties up to €600,000 for very serious infringements. In healthcare and pharma, serious infringements can lead to withdrawal of marketing authorisation. Final sanctioning decisions can be appealed before the National Court (State regulators) or the corresponding regional High Court.
The most critical situations are: receiving an inspection or report, the opening of sanctioning proceedings, applying for market-access authorisation, corporate transactions affecting authorisations or concessions, and regulatory changes requiring the operating model to be adapted. Preventive assistance through a monthly retainer is especially effective in sectors with frequent regulatory changes such as energy, telecommunications and pharma.
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