#EAPM – Patient access and #SPC waivers dominate health business 

| April 18, 2019
Just prior to Easter, (14-15 April), the Romanian Presidency hosted an informal meeting of EU health ministers, chaired by the country’s Health Minister Sorina Pintea, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

The event drew more than 140 delegates from EU member states of the European Union, who discussed the agenda topics “of political and strategic importance in the field of health”.

High up were themes addressing patient access to innovative medicine and patient mobility, especially for patients with rare diseases or those under the age of 18.

These are priorities for the Romanian Presidency of the EU Council in the field of health and health care, and were discussed in depth in Bucharest.

The meeting heard that Romania will continue its efforts to make progress on the agenda points which impact and benefit the health of European patients.

Minister Pintea said: “The main purpose of our activities during this period is to guarantee access to the health system for all European citizens.”

Regarding access to innovative and expensive medicines, the member state health ministers were invited to exchange views on actions taken at national level, with the possibility that some of these actions could be implemented at EU level.

They are also tasked with identifying possibilities to ensure access to treatment for the time period between the granting of a marketing authorization, its actual placement on the market, and the decision to reimburse the product in the relevant member state.

The meeting in Bucharest heard that rare diseases merit a special mention in the struggle to ensure early access to innovative medicines.

Europe’s health ministers also discussed possible solutions to ensure access to equivalent treatments for all patients with rare diseases in the EU, as well as ways to ensure access to treatment for patients enrolled in clinical trials at national level for the period since authorization, until the decision to reimburse the medicines is effective.

Patient mobility also came under the microscope, with ministers debating the implementation of Directive 2011/24 EU on the application of patients’ rights in cross-border health care, which for various reasons has has a less-than-optimal take-up thus far.

The ministers floated ways to work together to improve the effectiveness of the Directive, taking into account the findings of the European Commission’s report on the implementation of the Directive and the February 2019 European Parliament resolution.

Addressing the meeting, Minister Pintea said: “There is clear information to improve access to planned cross-border health care. The availability of appropriate information and guidance can reduce the administrative burden of repetitive applications and unnecessary administrative procedures resulting from the authorisation and reimbursement process.”

She added: “The reports of the Commission and the European Parliament on the implementation of the Directive identify a number of areas where improving information and increasing the transparency of the reimbursement process could lead to better informing the patients that are seeking cross-border health care.”

On patient mobility, the integration of European Reference Networks (ERNs) into health-care systems in EU countries was discussed.

ERNs are currently are in the initial implementation and/ consolidation phase, and are now facing a number of challenges to become operational and functional.

The over-arching goal is to bring benefits to patients suffering from rare or complex and low-prevalence diseases across the EU.

Unfortunately, these rare diseases patients are often children and, even while ERNs support all age groups, many cases involve minors.

The Bucharest gathering put a focus on identifying a set of policies and procedures that member states can put in place to incorporate these linked networks into all of Europe’s health systems.

Supplementary protection certificates

In Strasbourg, meanwhile, the European Parliament (16 April) held a debate on the provisional agreement via inter-institutional negotiations with the Council of the EU on the supplementary protection certificate for medicinal products, known as SPCs.

The following day, Parliament approved the provisional agreement with 572 votes in favour, 63 against.

Parliament was reminded that a compromise agreement was reached on 14 February, which amended the Commission’s initial proposal within just two weeks.

Apparently, this is a parliamentary record.

It was agreed by most member states and reconfirmed in the Legal Affairs Committee. Now, it has been passed in plenary.

The argument runs that, while the patent and the supplementary period of protection is still valid, companies could not store protected products, not even for exports for third countries where the patent protection does not exist or has expired.

On the other hand, other countries that do not have SPCs are in a position to do just that. As such, manufacturers of biosimilars and generics elsewhere in the world have a competitive advantage.

This is a key sector for Europe in the future, MEPs heard. It means the the EU must defend its knowledge economy, which invests approximately €35 billion helping new drugs come through every year.

Speaking to deputies in Strasbourg, Jyrki Katainen, vice president of the European Commission, said that the SPC waiver was an important element of the Commission’s Single Market Strategy, and an important deliverable for Parliament.

The Commission said that delivering for EU citizens and being seen to do so is important. And it is also also important in the context of the upcoming European elections. As such, he said, the Commission is very happy with the outcome of the trilogue negotiations, and added that Parliament and the Romanian Presidency had done an excellent job.

On stockpiling, the commissioner noted that it had been a sensitive issue for Parliament. He welcomed the flexibility shown by the Council and the Commission in accepting the inclusion that stockpiling will be allowed during the final six months of the SPC to better ensure day-one entry of EU produced generics and biosimilars after the expiry of SPC in the EU.

On top of this, every five years, an evaluation will take account of whether the provisions of stockpiling are enough. Specifically, the review clause in the regulation mandates the Commission to examine, inter alia, whether the six-month stockpiling period is enough to satisfy the objectives of the waiver.

On the topic of the date of application, Commissioner Katainen said that the waiver will now become effective reality by 1 July, latest – a date that respects the dual imperative of being both legally sound and economically useful.

As such, he said, there will be no retroactive impact on acquired rights. Likewise, rights of SPC holders in the EU are not affected since market exclusivity in the EU remains intact during the SPC term.

In addition, there will be a transitional regime so that due account is taken of the rightsholders’ concerns.

On safeguards, the Commission said he thought that the final compromise was robust and transparent. Exceptions will be accompanied by important and proportionate safeguards, he felt.

This includes proper notification rules which come on top of the new classified medicines ones that entered into force in February. At the same time, the regulation respects the needs of makers of generics and biosimilars to keep certain commercially sensitive information confidential.  Also, it complies with the Commission’s obligation to promote healthy competition both in the EU and beyond. He said that in the long-run this will mean cheaper prices for patients.

MEP Cristian-Silviu Buşoi thought it was important that the regulation gives a derogation to European companies allowing them to produce generics or biosimilars of protected medicines if exclusively intended for export to third countries, or for storage.

This means that they can come to the European Union on day one of expiry of the patent, the Romanian deputy said.

As a result, European producers can be competitive in third-country markets in which there is no producer protection. It also gives access to citizens to medications in those countries where essential medicines are expensive.

Slovenian MEP Alojz Peterle said that, in recent years, the costs of medicines have shot through the roof, Mr Peterle stated. They must ensure that medicines get on to the market faster. This means that patients will have faster access to cheaper medicines. This is yet another proof that the EU works.

The SPC revision was described this week as “a well-calibrated adjustment to the current regime striking a balance between ensuring the attractiveness of Europe for innovative pharmaceutical companies and allowing EU-based generics and biosimilars to compete on the global market”.

The manufacturing waiver “will help create growth and high-skilled jobs in the EU and could generate more than €1bn net additional sales per year and up to 25,000 new jobs over 10 years, particularly benefitting SMEs. More competition will improve patients’ access to a wider choice of medicines and alleviate public budgets.”


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