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Thought leadership and innovation for the Pharmaceutical Industry

Changing market dynamics and recent problems relating to Investigator Initiated Trials mean that the Medical Affairs function is becoming increasingly influential within the pharma sector in Japan. Nick de Cent talks to Dr Sumu Adachi, Medical Director at AbbVie in Japan.

By Nick de Cent on Sep 16, 2014

The pharma market in Japan is a market in transition.In the past, Japanese pharma sales have been built on a relationship model involving interactions between reps and physicians. Yet, as with other parts of the world, companies have been experiencing diminishing returns from this activity.

Meanwhile, as medicines grow ever more complex and specialized, doctors are seeking better and more scientific information in relation to products instead of a largely promotional dialog. Today, there is a clear imperative to differentiate between “science” and “sales”, and it is this priority that is driving the current trend among Japanese pharma companies toward setting up Medical Affairs functions that are distinct from the traditional sales channels.

Conflicts of interest

In the past few years, the relationship between physicians and the pharmaceutical industry has become increasingly controversial; surveys have suggested that there are frequent conflicts of interest in physicians' relationships with reps, and doctors can be inappropriately influenced by sales activity. For instance, a paper published back in 2010 and relating to 2008 data, “Japanese Practicing Physicians' Relationships with Pharmaceutical Representatives: A National Survey” found that “involvement in pharmaceutical promotional activities is widespread among practicing physicians in Japan.” While the extent of such involvement varies according to certain physician characteristics, as a group they are at risk of being influenced by promotional activities, the study suggested.

More recently, there has been controversy surrounding some Investigator Initiated Trials, with accusations of data manipulation by academics who are also in the pay of pharmaceutical companies. Accordingly, it’s time for Japan’s pharma sector to adopt a new model, suggests Dr Sumu Adachi, Medical Director at AbbVie in Japan.

“Japanese regulation is not as strict as outside Japan. Medical reps (MRs) have more freedom and a broader function compared with outside Japan. Boundaries between promotional and scientific roles can be blurred. MRs can also provide very useful scientific information. “For instance, after launch sales reps have an obligation to collect safety information. That’s a big difference compared with outside Japan.”

In contrast, sales reps are heavily regulated and can only provide a restricted amount of information related to a product.

Asked what role Medical Affairs should play within the Japanese healthcare market, Dr Adachi suggests MRs are now more scrutinized and they may only provide information related to a specific compound. “This is not so far from the physicians’ point of view.”

However, most Japanese companies’ sales reps carry many compounds – in contrast to the US and European model. Consequently, their knowledge is broad rather than deep. “Sales reps cannot answer all the questions about their compounds,” Dr Adachi stresses.

Scientific advice

In Japan there is a system of scientific advisers – “gakujyutsu” – who belong to the sales organization. Whenever physicians want to have a discussion including a higher level of scientific knowledge, for instance about toxicity in relation to a compound or around questions relating to clinical trial design, they would traditionally have that discussion with a gakujyutsu.

However, within a typical US  orEuropean structure, this role would more comfortably sit within the Medical Affairs function and outside of a direct sales role. Such a model is increasingly being adopted within Japan’s pharma sector. “Today, many organizations have a medical liaison group that is segregated from the sales group,” Dr Adachi confirms.

The Medical Science Liaison (MSL) is clearly different from the sales organization, Dr Adachi emphasizes. “Their objective is not a sale; it is to provide a scientific discussion.” In contrast, the gakujyutsu is there to support sales and increase sales. “That’s the difference.”

Nevertheless, there are concerns around MSLs’ ability to provide the right kind of information for physicians. Referring to the kind of data described above, he adds: “I hope that the MSL can answer that kind of question. I hope they have more scientific knowledge. If the MSL does not have those kinds of skills that is also a problem.”

The culture within a pharma company will be crucial in terms of smoothing the transition from sales-focused scientific advisers to a more objective, independent approach. There are concerns that MSLs may end up being the same role but with a different name. Although Dr Adachi admits that he doesn’t have any firm evidence that this is happening, he tells eyeforpharma.com: “This is one of the concerns that I have.”

Internal regulations

Particularly in the middle-sized companies there could be an issue if senior leadership fails to understand the need to distinguish between two fundamentally different roles. “If the top leaders don’t understand the true objective of why MSL is separate from sales, they may change the objective".

The MSL model, with the separation of Medical Affairs from sales, started to gain ground in Japan some three to five years ago, particularly among the bigger pharma companies. However, despite this change, problems do occur such as the widely publicized controversies around Investigator Initiated Trials, such as the alleged manipulation of data in relation to a sub-analysis of the Kyoto Heart Study by a Novartis associate in violation of the country’s Pharmaceutical Affairs Law.

“We should leverage this instance to go a better way,’ Dr Adachi declares. “After this happened, many companies have changed their internal rules. They cannot do the same thing the same way anymore.”

Physicians’ understanding of the limits of what pharma companies should be able to do also varies between different therapeutic areas, according to Dr Adachi. “This was a big surprise to me.”

Patients as consumers

Other trends are also altering market dynamics within Japanese pharma; as with many other parts of the world, patients are becoming increasingly consumerized. Patient behavior is changing and this can have an effect not only on the relationship between physicians and patients but also on pharma companies’ understanding of that relationship.

Although patients are wielding more power as consumers, they are doing so in a very low-key way, which often makes their views difficult to interpret. “Compared with when I was physician over 13 years ago, patients can ask more questions or complain more than before,” Dr Adachi acknowledges. “However, Japanese patients still hesitate to argue with their physicians.”

Instead, what happens is that particularly younger patients may swap doctors if they don’t agree with their treatment. “Patients can change physicians easily in Japan due to the insurance system. There is data that suggests that patients go to a different physician ‘silently’. Young people just go to another doctor.”

Today, an objective understanding of the scientific data behind a treatment is becoming increasingly important to both patients and physicians. This is driving not only new relationships between doctors and patients but also new ways of interacting between physicians and pharma companies.