IFPMA Interview: Antimicrobial Resistance, Regulatory Systems High On Pharma Industry 2016 Agenda

Priorities for the pharmaceutical industry in 2016 are antimicrobial resistance and the quest for new antibiotics, the strengthening of regulatory systems to facilitate access to drugs, and work on non-communicable diseases, such as diabetes and cancer, according to the head of an international pharmaceutical industry group.

For the International Federation of Pharmaceutical Manufacturers and Industries (IFPMA), specific issues need to be addressed to advance research and development, strengthen the health ecosystem, while at the same time enabling access to high quality healthcare for all.

According to IFPMA Director General Eduardo Pisani, who shared the industry’s perspectives for 2016 with Intellectual Property Watch recently, antimicrobial resistance is high on the agenda this year.

It is important to enhance research into new antibiotics, “without losing sight of the fact that any novel antibiotic will have to be carefully distributed to patients and be based on a commercially-sustainable model,” he said.

That applies to all players, he said, large pharmaceutical companies, medium-sized companies, and small biotechnology companies.

Pisani mentioned the 21 January Declaration [pdf] by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance, launched at the World Economic Forum in Davos, Switzerland.

According to a Review on Antimicrobial Resistance’s press release [pdf], “More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, have come together to call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections – so-called ‘superbugs’….”

“The statement sets out for the first time how governments and industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance,” said the release.

Pisani also underlined that the Dutch presidency of the European Union (until July) has antimicrobial resistance high on its agenda.

Regulatory Systems Key

“An increased convergence of regulatory standards is the only way that access to medicines can be accelerated and the quality of medicines delivered to patients, well controlled,” Pisani said.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is expected to include many additional regulatory authorities from countries, including emerging economies, according to Pisani.

The ICH announced [pdf] organisational changes in October 2015, and in particular a reform intended to “make it better-equipped to face the challenges of global pharmaceutical development and regulation.”

The reform, the ICH said in the release, will mean expanding beyond current ICH members. More involvement from regulators around the world is “welcomed and expected, as they will be invited to join counterparts from Europe, Japan, USA, Canada and Switzerland as ICH regulatory members,” according to the ICH.

Also part of the reform is “the possibility of wider inclusion of global industry sectors affected by ICH harmonisation,” the release said.

The African continent beyond the ICH efforts is very dynamic and evolving in the biopharmaceutical sector, especially when it comes to new policy and new regulatory frameworks, according to Pisani.

Strengthening regulatory systems will accelerate access because there will be a faster decision-making process, he explained. Today, he added, if a marketing authorisation application is submitted in South Africa and is approved in South Africa, for a tuberculosis medicines for example, it has to be submitted all over again in Nigeria, or in Kenya, and it takes years.

This issue has also been flagged by the generics industry, in particular for HIV and tuberculosis medicines, he said.

There is a very important initiative spearheaded by the World Bank and Gates Foundation which is called the African Medicines Regulatory Harmonisation Initiative (AMRH), Pisani said, adding that the initiative aims at facilitating convergence and harmonisation.

According to the AMRH website, “the overall aim of the AMRH Programme is to improve public health by increasing access to good quality, safe and effective medicines through the harmonization of medicines regulations, including the reduction of the time taken to register essential medicines for the treatment of diseases.”

“That is something that we strongly support and in which we are engaging,” said Pisani.

On the same issue of regulatory systems, Pisani underlined the increasing importance of the International Conference of Drug Regulatory Authorities (ICDRA – under the auspices of WHO). According to the WHO’s website, the 17^th ICDRA will take place in Cape Town, South Africa, from 29 November to 2 December (with a “pre-ICDRA from 27-28 November).

“Harmonisation accelerates access to medicines and systems strengthening enhances control of quality, which addresses the issue of spurious/fake medicines,” according to Pisani.

Non-Communicable Diseases still in Focus

The issue of NCDs will continue to be a focus of the pharmaceutical industry, he said, underlining the WHO Global Coordination Mechanism on the Prevention and Control of NCDs, which provides an “important platform to generate initiatives and partnership programmes,” he said.

However, direct and indirect contributions from the pharmaceutical industry to the issue to advance WHO plan might be influenced by the ongoing discussions between member states on the rules of engagement of non-state actors (such as civil society, industry, or philanthropy organisations) with the WHO (IPW, WHO, 27 January 2016).

“I am interested in public health policy,” Pisani said. “I am not interested in ideology and bureaucracy.”

UN Panel on Medicines Access

The IFPMA took note of the United Nations High-Level Panel on Access to Medicines, said Pisani. The panel was established at the end of 2015 (IPW, Public Health, 16 December 2015). Its objective is “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”

The panel has asked for contributions from all stakeholders, with a deadline set on 28 February (IPW, Public Health, 15 February 2016).

In a later comment, IFPMA Director for Public Affairs, Communications & Global Health Policy Mario Ottiglio told Intellectual Property Watch: “The ability of patients to obtain quality care depends on many factors – including health care infrastructure government policies, adequacy of funding, the presence of trained health care providers, health literacy and stigma. Addressing these barriers, in the pursuit of universal health coverage, requires collaborative efforts and innovative solutions which are both sustainable on the long term and practically implementable.”

“For the UN Panel to reach actionable conclusions,” Ottiglio added, “it must take a broad and holistic look at the full range of barriers to patients accessing treatment, including a broad range of perspectives from across global society, such as governments, patient organizations, civil society, academic institutions, and the private sector.”

 

Image Credits: IFPMA