Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

A number of European public-health and transparency campaigners believe that conflict-of-interest rules may have been breached with the EMA’s decision to allow its former executive director, Thomas Lönngren, to take up an advisory role within the private pharmaceutical sector. Lönngren left  EMA only a few weeks ago and has taken up several positions with private sector companies, including a specialized consultancy in helping pharmaceutical companies with product approvals for the European market. A 

 outlining the reservations has been sent to European Commissioner John Dalli on behalf of a number of organizations, including the Alliance for Lobbying Transparency and Ethics Regulation (ALTER-EU), Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB) and other public-health advocates.

In particular, the campaigners are concerned about the short space of time between Lönngren’s position at  EMA and his new employment positions, and question whether due consideration was given to the potential for conflicts of interest between the responsibilities and portfolios of a former EMA executive director and a strategic advisor to pharma companies whose products his previous role would have evaluated and authorized. 

“There are currently high-profile dossiers on pharmaceutical policies under discussions, including the revision of the Clinical Trial Directive, where we have concerns that a conflict of interest may arise involving Mr. Lönngren's past and current employment,” said the letter. “A former head of the EU drug regulatory agency has an extensive network and knowledge in the field, and this opens up the potential to influence the outcome of these dossier discussions.”

Lönngren informed  EMA’s management board of his intention to take up new employment roles in December 2010. In a 

, he also emphasized that there would be no conflict of interest, breach of code of conduct, nor any other breach of his legal contractual obligations as a departing EMA employee. The EMA board approved of his activities. 

However, the campaigners believe that the EMA failed to adequately check the potential for a conflict of interest. Olivier Hoedeman, on behalf of ALTER-EU, said in a statement: “When former EU Commission officials pass through the revolving door—as happens frequently—it is essential that clear checks are made to ensure they are not exploiting their knowledge and contacts to benefit the private sector. All too often, such conflicts of interest appear to be overlooked, showing that tougher rules and more rigorous enforcement are required.”

Articles

A number of European public health and transparency campaigners believe that conflict of interest rules may have been breached with the EMA's decision to allow its former Executive Director, Thomas Lönngren, to take up an advisory role within the private pharmaceutical sector.

EMA Challenged Over Conflict-of-Interest Case

Ongoing Free Trade Agreement (FTA) negotiations between the EU and India have hit a hurdle as some stakeholders urge the Indian government to fight against certain provisions in the FTA amid fears that access to generic drugs may be affected. According to a statement from Doctors Without Borders, the EU is “pushing for harmful intellectual property provisions” to be included in the FTA that will “hinder access to quality, affordable generic medicines produced in India.” 

India produces an enormous number of generic products, many of which are particularly popular in developing countries as cheaper alternatives to branded medicines. The country has been able to produce so many affordable versions of medicines patented elsewhere because it did not grant patents on medicines until 2005.  

“The EU is pushing for intellectual property provisions in the FTA that exceed what international trade rules require. The most damaging measure is so-called ‘data exclusivity,’ which would act like a patent and block more affordable generic medicines from the market, even for drugs that are already off patent, or do not merit a patent to begin with,” explained Doctors Without Borders.

India and the EU have been discussing an FTA since 2007. India is one of the EU’s most important trade partners; however, India still maintains “substantial tariff and nontariff barriers that hinder trade with the EU," according to the 

. A FTA would help to increase trade in both goods and services, but the EU has outlined a number of provisions that India must submit to, including, among others, strengthening its patent laws, which some believe will affect the supply of generic medicines.

 from the EU Delegation to Tanzania acknowledged these fears, but believes they are based on a misunderstanding of the EU’s objectives and negotiation position. According to the statement, the EU has proposed a clause in the negotiations to ensure that nothing in the FTA prevents India from producing and exporting medicines to developing countries. “The EU is fully aware that India is an important provider of generic medicines to other developing countries; the Free Trade Agreement currently under negotiations between India and EU is certainly not intended to restrict the ability of India to continue doing the same for domestic and international consumption.”

The EU–India FTA is expected to be finalized in spring 2011.

Generics Dispute EU-India Trade Negotiations

Ongoing Free Trade Agreement (FTA) negotiations between the EU and India have hit a hurdle as some stakeholders urge the Indian government to fight against certain provisions in the FTA amid fears that access to generic drugs may be affected.

EU–India FTA Dispute Continues

After reviewing further data on the suspected link between cases of narcolepsy and GlaxoSmithKline’s pandemic influenza vaccine, Pandemrix, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is still unable to establish a causal relationship. 

New evidence from a study in Finland has added to the concern by suggesting that there could be a nine-fold increase in the risk of narcolepsy in the vaccinated population, but the CHMP still believes that further analyses and study results are required, particularly as the risk does not appear to be a global phenomenon. According to the EMA, the majority of the narcolepsy cases have been reported in Finland and Sweden, but similar increased rates of narcolepsy have not been seen in other Nordic countries. “Additionally, in Canada, where there has been substantial use of this type of vaccine, there has been no evidence of an increase in reports of narcolepsy,” explained an 

The EMA has been investigating the safety of Pandemrix since 

 and recently the World Health Organisation also 

 a call for further investigation. The CHMP concluded that the study in Finland, conducted by the Finnish National Institute for Health and Welfare, was well designed, but unmeasured effects and biases could have contributed to the increased risks.

“One possible explanation for the results is that Pandemrix may have interacted with an unknown local environmental and/or genetic factor in contributing to an increased risk of narcolepsy among those aged 4 to 19 years in Finland,” said the EMA.

To further understand the concern, the CHMP says it is important to gather more data from the use of Pandemrix and related vaccines in a variety of countries. A number of studies are now underway, including an epidemiological study of narcolepsy and pandemic vaccines conducted by the European Centre for Disease Control and Prevention. The final results of this study are expected at the end of June 2011.

After reviewing further data on the suspected link between cases of narcolepsy and GlaxoSmithKline's pandemic influenza vaccine, Pandemrix, the EMA's Committee for Medicinal Products for Human Use (CHMP) is still unable to establish a causal relationship.

EMA awaits further safety data on Pandemrix

An initiative based in the Netherlands aims to bring together universities, pharma companies, international research institutions and product development partnerships to help develop new diagnostic tests and medicines for neglected tropical diseases. According to a 

 from the Top Institute Pharma (TI Pharma), one of the partners that helped to establish the initiative, treatments and tests for tropical diseases often do not exist, or can be unaffordable or of poor quality. 

The initiative, named the European Solutions Enterprise for Neglected Diseases (euSEND), is a joint effort by the Academic Medical Center of the University of Amsterdam, the Royal Tropical Institute, the Amsterdam Institute for Global Health and Development, Roland Berger Strategy Consultants and TI Pharma. "euSEND takes on the role of matchmaker: euSEND ensures that research expertise and financial means find each other,” Jayasree Iyer, Program Manager of euSEND, said in a statement. “Also, euSEND arranges for methods and technologies proven successful with other diseases to be tried in the research into neglected tropical diseases to produce innovative solutions."

According to the initiative, more than 1 billion people in developing countries suffer from neglected tropical diseases. Investment and innovation in this area, however, is low because of patients’ lack of purchasing power, which means little financial gain for pharma companies.

"This new Dutch initiative is a major step on the path to developing medicinal products and diagnostic kits for developing countries. We want to greatly speed up the development of medicinal products and diagnostic kits for tropical diseases while reducing the associated risk for partners and investors,” said Jorg Janssen of TI Pharma. “As euSEND wants to bring the right research partners together, the risk for investors is significantly reduced. In this way, we hope to stimulate progress and renew interest also in this currently commercially uninteresting field."

As a first step, euSEND has intitated three projects with the Foundation for Innovative New Diagnostics (FIND; Switzerland) that will focus on tuberculosis, leishmaniasis, which is an infectious disease transmitted by sand fly bites, and trachoma — the world’s leading cause of preventable blindness.

An initiative based in the Netherlands aims to bring together universities, pharma companies, international research institutions and product development partnerships to help develop new diagnostic tests and medicines for neglected tropical diseases.

New Initiative Tackles Neglected Tropical Diseases

Pharma’s manufacturing and supply chain needs a “radical overhaul” because it is underused, inefficient, and ill-equipped to cope with new types of products that will be coming to market in the near future, according to a report from PricewaterhouseCoopers (PwC). The report, 

Supplying the future: Which path will you take?

 is part of PwC’s Pharma 2020 series that examines the issues the pharmaceutical industry will be facing in the next decade.

PwC explains that the pharma industry is currently facing a number of significant challenges, with much attention focusing on drug discovery and the regulatory-review processes. However, it is crucial that companies do not overlook their manufacturing and distribution chains, which will be impacted by a number of trends in the lead up to 2020, says the report. In particular, new product types resulting from advances in nanotechnology, tissue reengineering, stem-cell research, and other innovations will require more complex manufacturing and distribution processes, and will also have a shorter shelf life. Some personalized medicines may even need to be finalized at the pharmacy or point of care.

A number of other trends are also necessitating the need for a change in manufacturing and distribution processes, including the shift of emphasis to patient outcomes; incremental product launches, such as limited label approvals and live licenses contingent on ongoing testing; new modes of healthcare delivery, such as electronic health records and e-prescribing; the growing importance of emerging markets and understanding the developing world; and greater scrutiny into the sourcing and manufacture of regulated products.

“In a world where outcomes count for everything, it’s not molecules that create value but, rather, the ability to integrate data, products, and services in a coherent business offering,” explained the PwC report. “Understanding this shift of emphasis from products to patient outcomes is critical.”

, Steve Arlington, global advisory pharmaceutical and life sciences leader at PwC, also added: "The most successful pharma companies will be those that recognize the underlying value locked in their supply chain and can leverage it as a value and brand differentiator rather than just a cost."

According to PwC, the pharma supply chain will undergo three key changes by 2020: it will become fragmented with different models for different product types and patient segments; it will become a means of market differentiation and a source of economic value; and it will become a “two-way street” with information flowing upstream to drive the downstream flow of products and services with the management of information transferred between the pharma company, patient, and healthcare provider being as important as the movement of the product.

According to Arlington: "Companies that recognize information is the currency of the future will be those that go the final mile and stand out by 2020."


Pharma's manufacturing and supply chain needs a "radical overhaul" because it is underused, inefficient and ill-equipped to cope with new types of products that will be coming to market in the near future, according to a report from PricewaterhouseCoopers (PwC).

Report: Pharma Supply Chain Underused, Inefficient, Ill-Equipped

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