Bratislava hesitates on pharma package, concerns voiced on RDP’s unpredictability [Advocacy Lab Content]

6 months ago 22

Slovakia is still in the ‘undecided’ camp for the EU Pharmaceutical Package’s regulatory data protection (RDP) system, but senior Slovak voices question the RDP’s unpredictability and exposure to external risk.

Euractiv discussed the Pharma Package with Peter Potúček, former director of the State Institute for Drug Control and member of the management board at EMA, currently a senior partner at PHC Project HealthCare think-tank.

“From my perspective, the critical aspect of the Commission’s proposal is the unpredictability of the proposed RDP scheme. The application of an additional two years of market protection will only be possible upon the introduction of the drug to the market in all member states,” said Potúček.

“A comprehensive revision of pharmaceutical legislation is warranted. Despite some controversial measures, this package moves the pharmaceutical sector into the 21st century and also provides enough tools for regulatory authorities to respond with more flexibility to rapidly changing environments in the future,” said Potúček.

Regulatory data protection

One of the packages’s most disputed issues was RDP, which ensures that confidential data submitted during the drug approval process remains undisclosed for a specified period. Safeguarding research investments incentivises and protects innovation.

“The question of the appropriate length of RDP is very complex; for some drugs, each month of market exclusivity can represent millions of euros in benefits. On the other hand, the proportion of drugs for which RDP is the only source of protection is estimated to be only about 1/3,” remarked Potúček.

The Commission’s proposal to shorten the RDP from the current eight years to six years was met with scepticism and disapproval from the pharmaceutical industry.

He added that this defined condition represents a significant level of external risk for every original and generic company in terms of business planning and may bring considerable instability to the market.

The Parliament’s position leaves the RDP at seven and a half years, with potential add-ons but sets a cap at eight and half years.

The potential additional ‘bonuses’ include an additional 12 months if the product addresses an unmet medical need, an extra six months if comparative clinical trials are conducted on the product; and six months if a significant share of the product’s R&D takes place in the EU or partly collaborates with EU research entities.

“From the perspective of RDP length and, above all, predictability, I consider the RDP model proposed by Parliament to be a good counterproposal, as it maintains a stable time guarantee for investment return. We must not forget that this was precisely one of the key factors that restored Europe’s competitiveness with the American market during the last pharmaceutical reform 20 years ago,” Potúček explained.

Launch conditionality

The Commission proposal included launch conditionality, ensuring two additional years of RDP if medicine was introduced in all member states, which has been scrapped by the Parliament.

“From my perspective, the most problematic aspect of this proposal is its practical feasibility. The requirement to introduce the drug to the market in all member states per se is a very vague definition, and impediments from just one member state would suffice to prevent its fulfilment,” he proceeded.

Restructuring European Medicines Agency

One of the revision’s main goals is improving access to medicines and reducing overall approval times for marketing authorisations. To achieve this, the proposal aims to streamline EMA governance and committee structure. This could, nevertheless, put more pressure on drug agencies and prove to be a double-edged sword.

Potúček highlighted: “If you look closer at various mechanisms, greater flexibility of the regulatory environment is being established, including shorter registration procedures and faster entry of innovative drugs. Together, they create much higher expectations from drug agencies as well as from the EMA, paradoxically, with a reduction in the number of its scientific committees.”

To optimise the functioning and efficiency of the regulatory system, EMA’s seven scientific committees are reduced to two: the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC).

The other committees are retained as working groups, giving input and working in support of the two main committees.

“The question then remains how sufficient the provision of the regulatory system’s operation is, considering its already significantly burdened capacity caused by Brexit,” he added.

Slovakia in listening mode

The revision is welcomed by Iveta Pálešová, executive director of the Slovak Association of Innovative Pharmaceutic Industry: “The new rules will strengthen the competitiveness of the EU pharmaceutical industry and support investments in research and development of new drugs. We believe that these reforms will lead to more accessible and affordable medications for patients in Slovakia and across the EU.”

The majority of Slovak MEPs across political groups voted in favour of both legislative acts, with only MEPs Uhrík and Radačovský (both NI) voting against the Regulation and abstaining from voting on the Directive.

It is now the Ministry of Health’s turn to formulate a preliminary opinion in response to the adopted proposals.

The Ministry of Health told Euractiv that it is currently finalising the preliminary opinions on the proposed legal acts aimed at revising the EU pharmaceutical legislation. They said that once finalised, the material will subsequently be submitted for “regular consultation”, with “detailed and specific opinions on individual topics (…) shared only after the initial publication within the consultation process.”

[By Filip Áč, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]