AIFD Working Bodies

Industrial Policies and R&D SMC

AIFD Coordinators

  • Cengiz Aydın, Investment Policies and Corporate Communication Director

Mentors

  • Daniel Lucas (GM of Lilly)
  • Renan Özyerli (GM of MSD)

SMC Members

  • Aysun Hatipoğlu (Novo Nordisk)
  • Burak Kıran (Sanofi)
  • Deniz Big Öncel (MSD)
  • Deniz Türkkan (B.braun)
  • Duygu Kara Dayıcı (Fresenius Kabi)
  • Ersen Gökser (Amgen)
  • Emel Mashaki Ceyhan (Takeda)
  • Emre Tüzer (J&J)
  • Gökhan Karaarslan (Pfizer)
  • Görkem Saka (Abbvie)
  • Gamze Gürses (Lilly)
  • Hande Göksoy (Sanofi)
  • Hülya Demirel (Novartis)
  • Müyesser Giray (AstraZeneca)
  • Özlem Oral Mamak (Novartis)
  • Selcen Erdem (Novartis)
  • Tülfer Sezer (Bristol Myers Squibb)
     

First joint SMC meeting with Market Access SMC was held on 5 December 2018:

The agenda and notes of the joint SMC is follows:

Agenda:

1. Opening: Introduction of SMC Members and why do we need joint SMCs?

2. Brief presentations of agendas of each SMC

3. How likely are prospective positive developments in other areas (e.g. partnering with government in clinical trials, startups, and patient engagement) to help market access advocacy?

4. How likely are prospective developments in reimbursement and pricing to help industry policy advocacy

5. Discussions

  • Parallel Trade
  • Forced Localization: Are we on the same page? Looking at from two perspectives, market access and industrial policy, what are the observations and experiences on the ground? Link between pricing and export

6. Wrap-Up and Next Steps

The first joint meeting showed the need and benefit of working together with a view to creating comprehensive and coherent positions for issue areas on the agenda. The participants agreed that this should be institutionalized by having a joint SMC every three months, starting with the next one in March 2019. The upcoming joint SMCs will tackle only few number of priority issues at a time to be able to elucidate insights that could only be obtained from an interdisciplinary perspective.

As for the focus of discussions, it was ‘parallel trade’, ‘visibility of prices’ and ‘compulsory licensing’ that stood out.

SMCs recognized that parallel trade and visibility of Turkish prices are problems mainly because of price levels (lowest prices in the region). On the other hand, pricing is a long-standing problem and short-term solutions (including new pricing system and advanced reimbursement schemes) are not possible while visibility of Turkish prices is still threatening sustainability of supply.

Market Access SMC was planning to engage with Government representatives for not sharing Turkey’s “success story” about pricing. However, it now became clear that the problem has reached to the point beyond “not creating awareness in other countries”, and became “hiding prices”. Hence, it is decided that the issue should be handled at the Board level. At the meeting, we discussed the issue from distribution model perspective and financial perspective, and later that week Market Access SMC decided to make two different studies: [Action]

Identifying the visibility of the prices

Working on the ideal model

Second main discussion issue was parallel trade. We suggest that AIFD can learn medical and economic aspects of the issue from European experience as it is heavily debated in Europe over the last decade. At the meeting, we argued that whether creating a “list of medicines not subject to export” is doable. However we, later, admitted that especially SSI does not recognize it as a problem and must be convinced that parallel trade is not ‘a proper export’. To achieve that, capacity building trainings to SSI and other commission members can be provided. This option be detailed further [Action].

Under the discussion of parallel trade the arbitrage of prices between countries, like Korea-China or Turkey-Middle Eastern countries, was highlighted. Low prices in Turkey, the root cause of parallel trade, is referenced by surrounding countries and this leads to significant losses in the region for global companies. It was also noted that when we talk to government officials we should make sure that we don’t give a wrong signal that prices or FX is not a problem and it’s only a parallel trade that concerns us.

Discussions led to the following critical questions in forming AIFD parallel trade position before meeting government officials:

Legal questions:

Is talking this issue among AIFD member companies a breach of competition rules?

Does TITCK/MoH have the legal ground to control/permit/prohibit foreign trade of drugs? If this is the case then how to reconcile this with MoTrade’s authority to regulate foreign trade in general? Which one has the upper hand in case of conflicting interests/positions?

What sorts of legal rights do companies have to intervene in the export of products by third parties?

Others:

What do we really mean by parallel trade? Confusion and mistreatment of parallel trade should be cleared so that everyone discussing the problem should be on the same page at least in terms of its definition. We should distinguish related yet separate issues like counterfeited goods and smuggling.

How much is parallel trade? What percentage of pharma market and pharma export is parallel trade? How to calculate it? Which body can do it?

Supply chain should clearly be identified and mapped with respect to parallel trade.

Relation between parallel trade and Fx/pricing

What are the similarities and differences between the case in Turkey and the EU?

What is EFPIA’s position?

SGK/ISS should be included as a partner in advocacy efforts.

We should make sure that AIFD and its member companies are always at the table when a measure is being considered and put in practice.

Another issue discussed was increasing threat of issuing compulsory licensing. AIFD is to monitor any developments about this imminent threat.

The participants also drew attention to a need to change narrative to better explain value of innovation to not only health related government bodies but also to economic ones like MoTreasury and Finance, MoTrade, SGK, and MoIndustry and Technology. More important move in explaining value of innovation would be to directly contact people who are members of critical decision making committees in healthcare/economic area. As part of this plan AIFD may help capacity building of related government bodies. A new group composed of medical directors from AIFD member companies may be critical to make cutting-edge scientific developments publicly available.

After the joint SMC regular SMC meeting took place on 21 December 2018 with the following agenda:

1. Parallel Trade

  • Do we need a survey to understand the scope of problem among AIFD members?
  • Can we identify concrete solutions that work for all members?
  • When to meet up with TITCK and MoTrade?

We noted that it’s high time for AIFD to play a constructive role in dealing with parallel trade when it has become a hot topic. Although we have a task force for parallel trade due to conflicting schedules we could not come together as planned. What’s more the issue deserves a more strategic approach from SMC members. We are pleased to announce that Aylin Aydoğmuş, senior lawyer experienced in all sorts of industry issues who previously was working for İEİS, joined AIFD team. She will be helping us as an external legal person. We discussed with her about parallel trade both from legal and trade perspectives.

So we decided that we should meet with those SMC members (Industrial Policy and Market Access) who are both avaliable and interested in the second week of January to discuss and determine the basic arguments. Having discussed as such we will submit a one-pager for the review of SMC, then we willl organize a meeting with TITCK to ask for action. Another relevant body we should see is Ministy of Trade. Of course there are many details involving the practice of parallel trade none of us is likely to know full. To solve this problem, at a time when we are to suggest concrete measures from TITCK, we need to identify right people from respective companies to inform us of the relevant details or how it actually happens on the ground.

Our aim is to make parallel trade high priority in January and to bring TITCK and MoTrade to the table for finding a solution given their already high interest.

Related to parallel trade and as per decision taken on joint SMC with Market Acces the same group for parallel trade may work on ‘price hiding’ exploratory work being conducted by Market Access SMC.

2. BIO Startup

  • Streering Committee
  • Comments on calendar and content of the program

Calendar starts with a call to be made first week of January on the following web page:

https://www.biostartup2019.com/

3. Value of Clinical Trials Study

  • Final comments on ToR
  • Steering Comittee

4. AOB

Joint meeting with Regulatory SMC on 18 January 2019 (our next SMC date)

Decision: Regulatory SMC agreed to have joint meeting on 18 January 2019. So our next SMC will be with Regulatory SMC.