EFPIA Supports Data Protection Reform

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-15-2015 13:20


The European Federation of Pharmaceutical Industries and Associations (EFPIA) issued support for data protection reform in the European Union (EU) following the publication of the "general approach" reached recently by the Justice and Home Affairs Council, which develops cooperation and common policies on various cross-border issues within the EU. The Justice and Home Affairs Council is made up of justice and home affairs ministers from all the EU member states.

On June 15, 2015, Ministers in the Justice Council sealed a general approach on the European Commission proposal on the Data Protection Regulation, which seeks to modernize and harmonize data protection rules that will contribute to the EU Digital Single Market. Trilogue negotiations with the European Parliament and the European Council will start in June; the shared ambition is to reach a final agreement by the end of 2015.

The aim of the data-protection reform, launched by the European Commission in 2012, is to enable people to better control their personal data, according to the EU Commission. At the same time modernized rules will allow businesses to make the most of the opportunities of the Digital Single Market by cutting red tape and benefiting from reinforced consumer trust, according to the Commission. It is hoped that a more rigorous and coherent data protection framework will provide for greater legal and practical certainty for citizens, businesses and public authorities, according to the Commission.

In March 2014, the European Parliament supported the Commission's proposal to reform data protection. The European Council has called for adoption of the data protection reform in 2015. The general approach on the Data Protection Regulation includes agreement on several key points. First, the regulation will establish a single set of rules on data protection, valid across the EU. Unnecessaryadministrative requirements, such as notification requirements for companies, will be removed, a move this is expected to benefit small- and medium-sized businesses.

The regulation requires that for citizens who no longer want their data to be processed and there are no legitimate grounds for retaining it, the controller must delete the data, unless they can show that it is still needed or relevant. Citizens will also be better informed if their data is hacked. A right to data portability will make it easier for users to transfer personal data between service providers.

Companies based outside of Europe will have to apply the same rules when offering services in the EU. Also, the regulation provides for more powers for independent national data protection authorities . The rules will establish a 'one-stop shop' for businesses and citizens: companies will only have to deal with one single supervisory authority. Individuals will only have to deal with their home national data protection authority, in their own language - even if their personal data is processed outside their home country.

The first Trilogue meeting between the European Commission, the European Parliament, and the European Council will take place on June 24 with the participation of Commissioner Jourov√°. The three institutions intend to agree on a roadmap toward the finalisation of the reform in 2015.

In commenting on the general approach, EFPIA said that "EFPIA considers that the General Approach has maintained the correct equilibrium, guaranteeing the perseveration of patient confidentiality, while ensuring that relevant data can still be gathered and disseminated with a view to advancing the fundamental scientific understanding of diseases and to improving the way in which we address medical conditions"

EFPIA said while it is keen to be part of the ongoing dialogue, EFPIA now calls on the European Commission, Parliament, and Council to uphold this balance and adopt a harmonized approach towards the creation of effective data protection rules in Europe. "Were this to be achieved, we believe that it would lead ultimately to improved outcomes for patients that would serve to boost the health of the general population and contribute to the sustainability of national health systems," EFPIA said in a statement.

EFPIA also welcomed the positive statement from academic, patient and non-commercial research organizations, published by the Wellcome Trust, which calls on the trilogue to consider exemptions for research, appropriate safeguards for data subjects and the need for flexibility and harmonization.

Source: EFPIA and European Commission


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