by Natalie Morrison at the Medicines for Europe and IGBA conference

LISBON, June 20 (APM) - Generics and biosimilars experts have criticised EFPIA for allegedly blocking European legal changes which could stop prolonged patent extensions and allow poor markets better access to drugs.

The proposed changes are to Europe's Supplementary Patent Protection (SPC) rule, which allows for an additional patent extension of up to five years on patents which already provide 20 years' exclusivity.

The SPC extension is supposed to compensate for the fact that companies do not have effective patent protection during "compulsory and lengthy" clinical trials and regulatory processes, the European Commission explains in its impact assessment document, released in February.

However, the Commission acknowledges several issues with SPCs including "loss of export markets and lead-time entry into Member States for EU-based generics and biosimilars, resulting in reliance on foreign based supplies". It makes a number of proposals, including allowing an SPC manufacturing waiver so European companies can export generics and biosimilars to countries with no SPC protection.

Experts at last week's Medicines for Europe and IGBA joint conference in Lisbon, Portugal, said this is a crucial step for the poorest countries, where European laws of Intellectual Property (IP) cannot ethically be applied. Patients are dying when they cannot afford the originator product, they said.

These countries do not have the same IP laws, and so it is not moral to impose those of Europe on them, the experts stressed.

However, a document allegedly from European trade body EFPIA - which is not public but which APM obtained through a trusted source - raises objections to this.

The alleged EFPIA document states that early European generic exports to third markets would be "at the expense of European exports of innovative products in pharma-emerging markets - substituting the export value of originator products for lower value generics".

The document also says that waiving SPCs in this manner would have a significant impact on European innovative companies in terms of monitoring and enforcement, noting that it would be "difficult and burdensome" to ensure products are only "exported to and remain in countries without patent protection."

"Finally, the alleged benefits of such a policy doesn't hold to replication by third countries. EU trade partners might take similar measures and seek to re-shape their IP policies to promote domestic production, whereas the EU has consistently argued against measures that erode IP protection in order to promote or accelerate domestic production," the document adds.

"There is therefore risk that the EU compromises its IP system for no gain at all in the long or short-term."

EFPIA was unavailable for comment on Tuesday prior to publication, or to verify the document.

However, several experts at the conference in Lisbon discussed EFPIA's alleged blockade of the new policies, which they said could hinder access to drugs in poor markets.

They included Adrian van den Hoven, chairman of generic and biosimilar medicines associations network the IGBA, who branded it "shameful behaviour".

During a Thursday press briefing in Lisbon, he said EFPIA's lobbying is delaying the Commission's legislative process on the matter, noting that the deadline for the proposed reform - currently set for the end of 2017 - is getting ever closer.

He added his disappointment that the European Commission had allowed the process to be delayed due to this lobbying, noting that the simple act of a public call for opinions has been pushed back consistently since March.

This is highly controversial considering widespread issues such as HIV in poorer regions, he said, noting that in Europe there is "basically a consensus" that industry does not enforce its IP laws in these countries since they have their own IP system.

Van den Hoven, who is also director general of Medicines for Europe, told APM on Friday that EFPIA's lobbying could also hinder a World Health Organisation (WHO) initiative to pre-qualify some cancer biosimilars for export from Europe to poorer markets to aid procurement. These include biosimilar versions of Roche's MabThera (rituximab) and Herceptin (trastuzumab), he said.

"Most poor countries in the world have zero access to these medicines; we hope this will enable access to these treatments for many poorer countries," he said.

"Of course very poor countries in Africa are not going to introduce patent extensions, SPCs, things like this. They can barely afford statins or the basic medicines they need, they are not able to buy super expensive patented biologics," he said.

The blockade is "not ethical behaviour", the president of Medicines for Europe - and Mylan's European president - Jacek Glinka told APM on the sidelines of the conference on Thursday.

"I think the European commission should be first in the world to say we are not in favour of these practices. Right now we are a little disappointed that they allow further delay of the process," he said.

Beside debating the ethical issues, the experts also argued that blocking SPC waivers for these poorer countries is bad business practice.

At the same press briefing, Glinka said industry wants to respond to the issue of the lack of access to drugs in poor countries.

He told APM that, long-term, this could lead to European companies shifting their R&D and manufacturing presence to countries outside of the European Union - such as to Asia - to enable exports to these poorer markets.

This goes against Europe's desire to play home to a high-tech industry, he told APM, and its desire to make sure education systems can be properly linked to development and manufacturing facilities, keeping talent inside Europe.

"I don't understand what kind of arguments reasonable people - politicians - can put on the scale to block this very important regulation from finally being approved," Glinka said during the press briefing.

"This is a regulation that the originators would like to continue to use to block us and to stop the possibility of expanding the access for such products," he added later, speaking to APM.

Van den Hoven also told APM that, in most cases, the EU already has the longest exclusivity period in the world, making the region globally "uncompetitive".

He said several European countries, such as Portugal, house big exporters to a number of developing and emerging countries, noting that disallowing these changes "hampers their ability" to supply these countries.

Paulo Lilaia, president of the Portuguese association for generic and biosimilar medicines Apogen - and Generis Farmaceutica CEO - added: "These kinds of barriers only help companies to move outside of Europe for production".

"This is not sense and will damage the economy of EU countries," he said. "If we have competitors producing outside of Europe and selling to those markets we do not have any other chance to move outside, so I think it's rational and the correct decision to be able to produce those products in Europe and sell outside."

The Commission itself identifies several issues with SPC extensions on patents, including "loss of export markets and lead-time entry into Member States for EU-based generics and biosimilars, resulting in reliance on foreign based supplies". It also notes that SPCs may not be adapted to the new wave of products such as personalised medicines and biopharmaceuticals, and the fact that there is already a "fragmented" Bolar exemption and SPC exemptions across Member States.

"The European-based generic medicines industry and API suppliers, and especially SMEs, do not compete on a level playing field vis-à-vis competitors based outside the EU," it said.

"They do not enjoy full business predictability across the internal market due to the opaque or insufficient definition of the SPC and Bolar exemption frameworks in some Member States."

It added: "EU consumers and patients might not enjoy full access to innovative developments if the right incentives are not in place."

The alleged EFPIA document argues, however, that IP mechanisms are "critical to preserve incentives to develop new medicines and distribute them to patients", adding that SPCs are particularly vital in light of the fact that the biopharmaceutical sector is subject to lengthy development and regulatory processes and the continued need to guarantee funding for research.

"Most importantly, at a moment where protectionist localisation policies are multiplying worldwide,[changes to SPC rules] would be sending a very bad signal about EU's respect for IP and seriousness about becoming a leading knowledge-based economy," the document states.

It also questioned whether SPCs are really hampering the generics industry's competitiveness globally, or whether opportunities and demand are actually there, given the fact that key export markets' generics sectors are dominated by domestically produced products.

/nm/clg