Market Access Innovative Agreements Spain
Between 2019 and 2020, the Spanish Transparency Council was given the opportunity to rule on several issues relating to access to pricing and reimbursement decisions. The Council`s position on transparency on this issue was quite unpredictable at that time. On the one hand, the Transparency Council adopted several resolutions asking THE MOH to disclose copies of the judgments in which the MOH agreed to refund certain products and to set its factory starting price (“PVL”). On the other hand, in other cases, the Council has taken the opposite position. In this context, in September 2019, the Commission denied a citizen`s right of access to the price and reimbursement decisions of a drug (and therefore to his ORC), on the grounds that such access would harm the legitimate interests of the company. In this case, the Council assessed the value of PVL secrecy from the point of view of the and stated that, if not confidential in the EU, prices would tend to be set at a level that might be low for richer countries, but too high for countries with lower economic capacity, making it difficult to access certain products. Development of Market Access Challenges and Remedies in Europe Key market access developments in EU Member States5 In 2017 (latest data available), 1,450 drug submissions were included in the NHS9 supply. Innovative pricing agreements allow stakeholders to agree on the value of new medicines. As in many other EU countries, the annual NHS (2) report published in December 2019 indicates that the Spanish pharmaceutical market is highly dependent on public policies, with around 73% of health spending coming from the public sector. With regard to the Spanish health system, Article 43 of the Spanish Constitution defines the right to health care as one of the fundamental principles: The measures taken by the Spanish government6 during the economic crisis that Spain suffered from 2008 to 2014, however, undermined such universal access to health care and set certain limits on the status of the beneficiaries of the system. Opinions differ as to whether the agreements should be local or regional/national. If, at the time of a price decision, a similar comparison is available on the Spanish market, the authorities use “internal reference prices”. This means that the price of a competing product within Spain serves as a reference price.
Challenges and barriers to market access across Europe continue to be widely debated in a pervasive context of cost-cutting and budgetary pressure. At the same time, the health world continues to rotate and the pharmaceutical industry must move forward and ensure that the latest drugs reach the patients for whom they are intended. But what is the current state of mind among payers? How effective are market access strategies in today`s climate? And what do drug policy makers think today about how the industry responds to the immense challenges they face? Payers expect the use of innovative price agreements to multiply in Europe. At the national level, the Agencia Espaéola de Medicamentos y Productos Sanitarios (Agencia Espaéola de Medicamentos y Productos Sanitarios) authorizes and classifies new drugs at the national level and the Directorate General of Pharmacy and Health Products, which is part of the AEMPS, evaluates drugs and is responsible for defining pharmaceutical policy, evaluating drugs before entering the market and making decisions. When a manufacturer requests approval to market a product, it must submit an AEMPS verification file.