Novatis affairs

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Public Affairs

Public affairs strategy February 10, 2017


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Contents 01. Background Overview 02. Strategy Prior to Next Milestone 03. Stakeholders mapping and possible approach 04. Appendix

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Background

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Coverage driven by leaks • Over the course of the last two months, media coverage of the Novartis case has been primarily driven by leaks and statements from governmental officials/MPs and other stakeholders (such as Hospital HCPs Association of Achaia, professor Maniadakis and other stakeholders - profiles are included in stakeholders mapping). • Such leaks that seem to come from sources in the political and judicial environments are a common phenomenon when big or sensitive cases hit the Greek press. Factual coverage skewed by history and political motivations • Coverage is factual at first glance, but when viewed in the context of the overall political and societal environment in Greece it becomes clear that in fact the overall prevailing sentiment is negative. • This is because of: – The pharma industry’s negative legacy as a result of older cases of alleged business misconduct (indicative recent cases are mentioned in slide 7). Such cases have historically resulted in big pharma multinationals being portrayed as “vultures of the Greek economy.” – The careless use of words by media or public figures, referring to misconducts or scandals rather than alleged misconducts. – The public’s general distrust and established perceptions that the Greek political system is corrupt and that big corporations have been favored by such as system, as well as the overall unregulated business environment. Such perceptions seem to focus especially in the years that New Democracy (the current opposition party) and PASOK (center-left wing party that has lost its power over the years) were in office. This is a perception that the current government is also trying to encourage. – The pharma industry in specific is overly regulated (in terms of legislation), but there is lack of compliance in terms of implementation of rules of regulations Alleged improper business practices made an official issue by Minister Xanthos • In mid-January, Minister of Health Andreas Xanthos referred to the “Novartis scandal” during his speech on health reforms at the OECD Forum in Paris. – “The recent publicity on the Novartis scandal forces us to create ‘safety valves’ in order to “armor” the procedures of licensing-pricing-compensations of new medications, etc.” • This statement, made in front of an international audience, made the issue official. In essence, the Minister of Health confirmed that there is an issue in relation to the alleged improper business practices and implicitly signaled the government’s intentions to impose stronger controls (in terms of strict legislation referring to new drugs released in the market) in the sector and investigate the case.

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Political context (1/2)

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Highly polarized environment during a long pre-elections period • This is unfolding in a tense political environment, as it is highly possible that Greece is entering a long pre-elections period in which SYRIZA (the current government's party) is aware that its popularity has decreased and Greek society remains disappointed. • In this context, the government is looking for ways to boost its popularity and unite its voting base. With that motivation, the current government is ready to open files against its main opposition, which is one of the former governing parties (New Democracy). This, even though New Democracy was not the only governing party during the years under investigation, as PASOK was the governing party between 2009 and 2012. • To mark the current government’s two-year anniversary since coming to power, the PM’s office issued an unofficial communication outlining the successes to date and giving an indication of the government’s priorities for the near future. Those priorities include the “fight against corruption” -- naming Novartis as an example. • The fact that the Novartis case is allegedly linked with Minister(s) that were in office during New Democracy’s administration and former PASOK MPs strongly suggests that it will become a talking point in SYRIZA’s rhetoric about the corruption of previous administrations. • Notably, the current SYRIZA Ministry of Health has proactively protected itself against possible allegations of corruption by having its officers consistently refuse any contact whatsoever with the private sector and multinationals in specific. They are declining meetings with C-level pharma executives, even if they are placed in a business-as-usual context. A fact which is not the case for Greek pharma companies. Main opposition party gaining in polls, but is allegedly implicated • The latest polls show a clear lead for the main opposition party, New Democracy, driving the current government to adopt a more offensive communication strategy against them. • New Democracy has traditionally been the center-right parliamentary force and has maintained strong relations with the private sector, as a matter of ideology. • During the years that New Democracy was in office (2004-2009), Ministers appeared publicly with private sector representatives as common practice, with the Minister of Health of the period 2007-2009, which was D. Avramopoulos current EU Commissioner, being especially active. • When New Democracy later returned to office (2012-2014), they attempted to regain the support of the private sector (especially multinationals and foreign investors), but in a more institutional way, with the PM holding publicly announced business meetings with C-level Officers of the key players in the Greek economy (not only pharma – all economy sectors). This was a period of a triple cogovernment with New Democracy (leading party), PASOK and DIMAR sharing office. • This is the history that the current government is using to attempt to harm New Democracy’s credibility. Taking this a step further, SYRIZA is now planting unofficial allegations and suspicion on specific members of previous New Democracy administrations, without officially naming them (D. Avramopoulos, former MinHealth and current EU Commissioner and A. Georgiadis, former MinHealth).

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Political context (2/2)

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The Ministry of Health maintains a dual stance in relation to the Novartis issue • While the Minister of Health, A. Xanthos, is quite careful in his choice of words, Alternate Minister of Health P. Polakis seems highly polarized and aggressive. • For example, Minister of Health A. Xanthos maintained a removed stance during a Sunday interview in Efimerida ton Sintakton, mentioning that the case is in the jurisdiction of the Ministry of Justice and that authorities supervised by the Ministry of Health (EOF, EOPYY, IFET) have been asked to provide data on the case. • In contrast, P. Polakis linked the Novartis case with the KEELPNO case (see slide 7 for outline of case) in an interview in Sunday’s Avgi newspaper. • This shows the dual role of the Ministry; appearing on the surface to be balanced and factual, while still taking opportunities to launch targeted attacks. While New Democracy & PASOK have remained absent in the debate up to yesterday (1/2) • Even while former Ministers of New Democracy’s administration are being portrayed as potentially implicated in the allegations involving Novartis and PASOK’s administrations were also active during the years under investigation, the parties have made no official statement. Debate for corruption in Parliament – Issue raised by the PM causing political juxtaposition with New Democracy leader • The issue of corruption was extensively discussed on 1/2 in Parliament, creating political juxtaposition among the Greek PM A. Tsipras and the leader of the opposition (New Democracy), K Mitsotakis. Addressing to the House, Mr. Mitsotakis accused the PM of being populist and trying to stop his downfall via favoritism and ostensibly fighting corruption. Among others, Mr. Mitsotakis, mentioned that the current government is trying to build ‘a new corruption, worse than the old one’. Mr. Tsipras, on the other hand, blamed previous governments of New Democracy and PASOK for several corruption incidents of the past, “How many millions did ND and PASOK stash into their secret funds and where did they end up?” he said and then in a context of bribery issues mentioned Siemens and Novartis. “It’s time for answers,” he said. The PM ended up, highlighting that the corruption “file” just opened and justice will have the last word. Minister of Justice, S. Kontonis says Novartis is bigger than the Siemens scandal • In his comments to reporters on Saturday 4/2, Minister of Justice, S. Kontonis described the alleged scandal involving Novartis as “much more significant and more serious than Siemens,” referring to a major cash-for-contracts scandal involving the German electronics and telecommunications firm.

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Healthcare environment & potential risks

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Healthcare economics suffering severely • Greece’s creditors have made the reduction of pharma expenditure a top priority since the country first entered the aid program. The trend has been downward the past few year with the national healthcare budget currently amounting to less than 5%. • This has driven government measures against the industry, including increased taxes on pharma companies (rebate, clawback, etc.), a generics friendly policy, caps on HCP prescriptions, etc. • The importance of healthcare to the national budget increases the influence of key persons in the Ministry of Health over the country’s fiscal decision making. The Secretary General for Public Health, I. Baskozos is part of the decision making chain, but is not necessarily highly influential • Important pricing issues include drug shortages, repricing and new entries. • On Jan. 25, I. Baskozos, the Secretary General for Public Health publicly referred to drug shortages that the market is experiencing and attributed them to four causes: Problems with the production process (vaccinations), problems with the sufficiency of imports (old "orphans" and drugs of limited use), problems with adequate quantities due to parallel trade or the withdrawal of products because of extremely low prices, and "artificial shortage" problems created by pharmaceutical companies for countries with economic problems and fiscal limitations – such as Greece. It should be noted that pricing is highly legislated and no negotiation takes place. Calculation of local pricing is based on Ministry’s own data, info submitted by companies & official European Databases. • The EOF (the Greek FDA) Pricing Department required pharmaceutical companies with new products (reference, generics, hybrids) to submit research sheets and the data for pricing of pharmaceutical products by Jan. 30. Once this process is complete, we will see new drugs available in the Greek market -- an issue for which the industry has been lobbying intensively. In certain cases, even if EOF’s committee positively comments on a specific product and even thought the procedure is very specific, the Minister needs to sign the final decision with interventions being possible thought this decision making chain. Current sector-wide pricing issues may potentially pose risks to Novartis • These risks might not be immediate, but when discussions around these issues are on the rise, they could create opportunities to remind the public of the allegations against Novartis or even pose new questions about its practices. • Some proactive preparation is needed, in order to be able to quickly address these issues: – Artificial shortages: Is Novartis facing shortages that may be interpreted as artificial? If yes, which drugs? Which therapeutic areas? Are there alternative drugs available in the market? – New entries: Is Novartis expecting new drugs to get pricing approval? If yes, how many? And what is their cost? Disclosure implementation • The disclosure law (introduced by New Democracy following EFPIA directives) was not implemented in Greece due to concerns about HCPs’ personal data protection • Once discussions of the disclosure law start up again, they could prove to be another opportunity to remind the public of alleged misbehavior

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Healthcare reputational issues & legacy (1/2) The pharma sector has a history of reputational issues The big pharmas’ history of facing allegations of overcharging means they can become an easy scapegoat for any financial issue in the sector, not to mention an alleged scandal. Indicative older cases include:

• KEELPNO – Center of contagious diseases & outbreaks. The so called “KEELPNO scandal” is a complex case as it involves a number of different corruption cases. Although KEELPNO is funded by the Government as a chapter of the Ministry of Health, it is not actually controlled officially for its practices or hiring procedures. So, KEELPNO has – for a long time – acted as a money laundering organization for almost all different governments. During all these years, a number of financial scandals have taken place and are currently being investigated related to: – excessive spending, – under the table hiring procedures, – really high salaries, – cases of discrepancies in tender procedures, – as well as advertising spending (Although as a health-related public organizations it is allowed to advertise for free). There are also allegations for bribing cases involving journalists, as well as, politicians. Recently, ex-president of KEELPNO, Alternate Minister of Health, P. Polakis was accused for an intervention in a competition for the recruitment of Intensive Care Units personnel (doctors and nurses), in the context of which P. Polakis issued his own list of successful candidates bypassing all legal procedures. Following that P. Polakis has asked, through a Facebook post, the KEELPNO BoD to resign in order to proceed with a new BoD and start a reform in the organization and the way it operates. Despite the reactions, the government finally removed KEELPNO president and nominated a new BoD in May 2016 with Theofilos Rosenberg as President.

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Healthcare reputational issues & legacy (2/2) The pharma sector has a history of reputational issues • Depui - DePui, a subsidiary of Johnson & Johnson was alleged for bribing doctors in order to secure contracts for the equipment of hospitals between 2000 - 2006. Representatives of the company in Greece, as well as from its UK headquarters, were among those due to go on trial, along with doctors accused of accepting under-the-table payments. DePuy is accused of causing Greek taxpayers’ losses of 11.5 million euros because it allegedly hiked the cost of equipment it sold to public hospitals by 35 percent. However, in November 2016, an appeals court in Athens has decided to postpone indefinitely the trial of 24 suspects in connection to the sale of orthopedic equipment to Greek hospitals by DePuy. The judges decided to call off the trial after accepting an argument from the defense that the suspects had not been notified about the trial promptly. • Roche – The Roche case was known as the “Skopouli scandal.” There were allegations that F. Skopouli, the Deputy. Minister of Health in 2012 (New Democracy- PASOK – DIMAR common administration) was promoting the provision of Roche reactors at a time when a) Roche was financing her husband’s research and b) another competitor had already donated the same type of reactors to the state. The case received a lot of publicity, but was never officially pursued or resolved. Skopouli was a DIMAR (leftist party that used to be in a coalition with SYRIZA) representative of the common administration. The motive behind the exposure of the case was clearly political. -

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The Siemens case This is a case that over the past decade has turned into a synonym to bribery scandal. In this respect it is an interesting case to have in mind, as there are already mentions in the media that the Novartis case might be of equal importance to that of Siemens. This is also case that unfolded during PASOK and New Democracy (main opposition now) administration and allegedly implicated former Minister of Health, D. Avramopoulos. Specifically: • The Siemens scandal in Greece appeared as a series of corruption and bribery incidents regarding several deals between the German company Siemens AG and Greek government officials, during the period 1990 – 2006. According to the investigations that begun officially in 2006, Siemens spent the amount of €1.3bn in order to secure contracts with several countries around the world (including Greece), for the supply of materials, services and security systems. According to testimonies by Siemens executives, the total amount of 130 million German marks, was given illegally to members of Greek governments, for projects including the Olympic Games of 2004 and purchases by OTE (Hellenic Telecommunications Organization S.A., now owned at 95% by Deutsche Telekom). • A Greek prosecutor, after two years of investigations, filed charges on July 1st 2008 for money laundering and bribery. Theodoros Tsoukatos and Tasos Mantelis, former members of PASOK governments, admitted that they received money from Siemens, noting also that the money was used for the needs of the party (PASOK), including pre-election campaigns. Over the years, rumors appeared involving also members of New Democracy, with reference among others in the Former Minister of Health of the Party, D. Avramopoulos. • Although there is still no conclusive evidence, Siemens is probably the biggest scandal of the Greek contemporary political history, having a serious impact in the attitude of the Greek public, causing political instability, dissatisfaction and lack of trust for both main political parties in Greece, New Democracy and PASOK. • Investigations are still underway, examining the ratification of the compensation that Siemens will have to pay for the scandal to the Greek government, as well the involvement of former and active Greek politicians and German executives of Siemens. • In early January, a related trial commenced in German courts.

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Key players in the public discussion about Novartis (1/3)

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P. Polakis, Alternate Minister of Health – Seems to play a pivotal role in shaping the story, as a leak that has possibly started from his office is causing more names of key stakeholders and other cases to re-surface. • Alternate Health Minister P. Polakis is reported to have a relationship with Documento newspaper. Documento is owned by K. Vaxevanis, a journalist who has revealed names and already extensively covered the issue. The Documento story is possibly based on a leak from Polakis’ office • Media owned by Vaxevanis also directly attack Adonis Georgiadis (former Minister of Health during 2013-2014) and currently Vice President of the New Democracy party). • P. Polakis has connected the Novartis case with the KEELPNO scandal. This implicates – by context - EU Commissioner Dimitris Avramopoulos, the former Minister of Health (2006-2009). Additional information on the KEELPNO case is outlined in slide 7. • Within the frame of a political event held by SYRIZA (4/2), P. Polakis analyzed the alleged price-fixing scheme, potentially adopted by Novartis which was extended in many countries around the globe, setting a ‘millions’ party. Documento & Kostas Vaxevanis • Documento is a newspaper very closely linked with the current government and is considered a media outlet that is running stories promoting this administration’s agenda • Kostas Vaxevanis, its owner, started as a war zone reporter and later shifted his focus to investigative journalism aiming at uncovering big stories of corruption. He has a reputation of a journalists that likes to think he is serving justice for society. Nikos Maniadakis, professor of the National School of Public Health and member of the Advocacy Committee of the European Society of Cardiology, has also been implicated. • Documento’s reporting has also implicated a professor of the National School of Public Health, Nikos Maniadakis, who worked as a counsel to the Ministry of Health during the Karamanlis administration (New Democracy 2004-2009). He is reportedly among those shaping the pharma industry’s pricing and reportedly had a close relationship with Novartis • Additionally, according to press reports, Nikos Maniadakis owned -- along with his wife Christina Farmaki -- a company that conducted studies on behalf of Novartis, during a period when N. Maniadakis had an active role helping to shape pharma policies by negotiating with the Troika (as reported in cooperation with former Ministers of Health, A. Georgiadis, A. Voridis – both New Democracy MPs). • He is also a member of the Advocacy Committee of the European Society of Cardiology, acting as an advisor to issues relating – among others - to the financial burden of cardiological diseases. • Maniadakis was forced to issue an announcement to deny allegations. Business Use Only Public Affairs


Key players in the public discussion about Novartis (2/3)

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Olga Gerovasili, Minster of Administrative Reform, has commented publicly. • In a recent interview, Gerovasili implied that practices such as Novartis’ alleged improper business conduct have caused social inequalities – meaning that they severely harmed the state’s finances. S.Kontonis, Minister of Justice • S. Kontonis, the current Minister of Justice is seemly maintaining a factual stance, but his statements in the media include references to ethics and an issue that might be one of the biggest the country has seen, comparing the alleged Novartis case with the Siemens scandal • Journalist Gianna Papadakou, who is investigating the case and has participated in public TV reporting on the Novartis case, is close to the Minister of Justice, S. Kontonis • G. Papadakou seems to lead the reportage about Novartis, as she is the one to introduce new story elements from a judicial point of view. • In the context of a visit in the island of Zakynthos (4/2), Stavros Kontonis revealed that representatives of the US Justice Department are expected in Athens this week (w/c6/2) to be briefed on the progress of an investigation into alleged corruption by the Swiss pharmaceutical giant Novartis. Mr Kontonis also mentioned that the Novartis scandal is far bigger than the Siemens one. A. Xanthos, Minister of Health • Andreas Xanthos, Minister of Health, maintained a removed stance during a Sunday interview in Efimerida ton Sintakton. He mentioned that the case is in the jurisdiction of the Ministry of Justice and that authorities supervised by the Ministry of Health (EOF, EOPYY, IFET) have been asked to provide data on the case. • Xanthos seems to be acting as the current Ministry of Health’s voice of reason, with Deputy Minister P. Polakis playing the aggressive role. I. Giannoglou, VP of EOF • EOF’s vice president, Ilias Giannoglou, maintained a neutral position during an interview in Avgi (29/1/2017). He talked about alleged non-transparent procedures that allow under-the-table transactions and called on the government to create a legal framework that will protect the health system.

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Key players in the public discussion about Novartis and their interrelations (3/3)

A.Georgiadis, New Democracy Vice President, former Minister of Health (2013-2014) • Adonis Georgiadis is “photographed” by context in mentions relating to case as an allegedly implicated political figure D. Lintzeris, Former PASOK MP and former EOF President • D. Lintzeris, a former PASOK MP and former President of EOF was placed under SDOE’s investigation during the last few days in relation to the Novartis case. • D. Lintzeris was a suggestion of Adonis Georgiadis for the position of EOF presidency back in 2013. Achaia Doctors Association • A statement was issued over the weekend by the Achaia Doctors Association inviting the Ministry to reveal the names of all those involved in the Novartis case. • This could be an indication that the case is being used for pre-electoral purposes by regional HCP associations. This link will be investigated further and we will return with input as to the regions that might have upcoming elections.

Sarakis Lawyer • This is the lawyer appointed by the 2 whistleblowers. The name appears in media coverage as playing a role. Profiling is pending.

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Near Term

Strategy Prior to Next Milestone

The strategy refers to overall external engagement, in which PA outreach is step 3, following a possible significant development in the case and respective media outreach as outlined in the Media strategy document


Consider Engagement Options During Pre-Milestone Period

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Current approach is fully reactive Pros • Minimal risk related to engagement • Preserves integrity and optionality of legal process • Keeps attention and media coverage volume to a minimum

Cons • Minimal Novartis voice in the market or in media coverage • Opponents’ perspectives dominate and drive coverage • Limited flow of feedback/intelligence from key contacts

Consider shift to cautiously proactive approach across stakeholder groups Pros • Build credible dialogue before next milestone • Educate stakeholders re: seriousness of Novartis response • Open two-way lines of communication with key contacts • Maintains focus on mitigating risk and preserving integrity of legal process Cons • Still does not eliminate negative speculation/rhetoric • Possible slight increase in risk given engagement

• Would have to be controlled and calibrated based on changes to the status quo. • On the business front: maintain “business as usual” to the extent possible. • Working group should re-evaluate external speaking/events through Q1 in light of the circumstances. Business Use Only

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Cadence of Engagement Step 1: Selective Background Media Engagement

Step 2: Consider Targeted Stakeholder Engagement

Step 1: • Background conversations with top-tier pharma media; done by local comms team

Step 2: • Background meetings between V+O and additional selected media to gather intelligence

Step 3: • Depending on intelligence gathered: • Assess distribution of official company statement at the next major milestone or spike in media coverage • Consider briefings of key judicial journos and media KOLs 15

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Based on intelligence gathered from targeted media meetings and most recent developments, consider appropriate timing and approach to public affairs engagement in close coordination with legal team

PA outreach will be prioritized based on stakeholders clustering that distinguishes between case related stakeholders and ones that the company plans to engage with in a business as usual context

Type of outreach may include 1:1 briefings or formal coms such as a letter to selected key stakeholders


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Rationale of possible PA engagement

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The decision to execute this strategy will be dependent on 1. intelligence gathered during the initial media engagement, if we decide to proceed with the specific media approach, 2. case-related developments and 3. the need for business-as-usual (BAU) PA outreach that will possibly raise the need to communicate top-line issue specific messaging. Outreach that may be decided to address non-BAU stakeholders, may possibly need to follow the issuance of an official media statement in reaction to a milestone or spike in press coverage. The spike refers to a new story ran in the media in relation to hard facts or specific judicial or procedural developments. For example this might be a subpoena. Depending on the type and content of such a spike, we will identify the key stakeholders that we will need to consider addressing It is important to note that the content, method and timing of approach may need to be differentiated depending on whether : • we are approaching case related stakeholders • or engaging with pharma-sector stakeholders in a business as usual context

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Method and approach to possible PA engagement • • • • •

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Communication with key PA stakeholders needs to be straightforward and ideally formal a point which is further analyzed in the next slide This will ensure that there are no grey areas and we will not risk being accused of improperly attempting to manipulate the situation from behind the scenes. Alignment is also necessary, in terms of timing, with the media outreach that has been suggested in the media strategy. The format of the outreach could include letters and/or 1:1 meetings Decisions will need to be made on the following 2 fronts, which are analysed in the next 2 slides: • What kind of outreach will we implement (official vs. unofficial) • Who will be the spokesperson (global vs. local)

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Official vs. Unofficial PA outreach Official outreach

Unofficial outreach

Pros

Cons

Pros

Cons

Is straightforward and shows determination and integrity

Is highly likely to result in content being leaked to the press

Company doesn’t express any official position that may later be misinterpreted

May look as if we have something to hide

Doesn’t allow much room for misinterpretation or grey areas

This in turn may raise further attention to the issue

May help further intelligence gathering

Stakeholders may be reluctant to meet with company reps in the absence of official request

Possibly easier to contain in terms of media leaks

Overall the approach doesn’t comply with the integrity approach that our key messaging is based on

Requires a solid story line, which in turn helps with perception of credibility May help limit speculation around the case

Could help communicate messages that we cannot officially announce – if needed

Will support the need to right-size the issue in KOLs’ perceptions

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Global vs. Local spokesperson in PA outreach The decision that needs to be made refers to whether the spokesperson that will sign any formal letters that we may decide to send out, or participate in any meetings with key stakeholders will be a member of the local management team or a Global representative of Novartis. This refers only to outreach addressing issue-related stakeholders not ones that will be approached for business as usual purposes. The BAU group will be inevitably reach out to (possibly in an indirect way) by the usual local Novartis reps that they cooperate with.

Global PA spokesperson

Local PA spokesperson

Pros

Cons

Pros

Cons

Approach allows Novartis as a global corporation to distance itself from local alleged improper business practices

May create perception that there is lack of trust and confidence in the Greek team

By including the local team Novartis shows that they are trusted

Names of local management may be exposed in publicity in a negative context.

The Greek team has established relationships with certain stakeholders and this might make the outreach process easier

Makes it easier for the local team to avoid having to respond to

A possibility that should also be examined is the use of a combination of global and local spokespersons to balance pros & cons Business Use Only

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Key Messages (same as in media strategy) (1/2)

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Novartis takes any allegation of misconduct extremely seriously and thoroughly reviews all reports. We are committed to understanding what, if anything, took place. • We are cooperating fully with the authorities and are providing them with all necessary information. • In fact, we have launched our own internal investigation fully examining any actions in Greece over the years in question. • Novartis began the investigation even prior to receiving a formal notice from Greek authorities, including a subpoena or other formal notification. • Our aim is to ensure there are business practices that are in violation of our Ethics & Compliance standards or local law.

We are committed to the highest standards of ethical business conduct and regulatory compliance in all aspects of our work. • Novartis seeks to ensure both our governance and culture is firmly embedded throughout the organization. • We want to empower associates to go beyond simply following the rules by making better decisions guided by our shared company values. • Novartis monitors compliance in close in collaboration with the business and our Legal, Finance, Internal Audit and Business Practices Office teams. • When issues do arise in in the business, we work quickly to address gaps and use these instances as learning opportunities.

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Key Messages (same as in media strategy) (2/2)

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Novartis is early in the process of investigating these allegations and is fully complying with all investigative bodies. • • • •

On two occasions the Greek authorities have requested information during visits to our premises. These two visits by a prosecutor have been the only contact from the Greek authorities to date. We are fully cooperating with the authorities in the U.S. Novartis has not received a subpoena at this point.

Much of the information previously reported is speculative at this point. Novartis is committed to understanding the facts of this matter. • Statements made to media by third parties referring to 4 billion Euro in illegal profits are speculative. • Official data (EFPIA) shows the ex-factory value of the Greek pharma market is around 3.6 billion Euro, of which Novartis accounts for about 0.4 billion Euro. • As it relates to pricing, in Greece prices are not negotiated, but are set by the Greek state and EOF based on the average of the 3 lowest EU prices. • Novartis conducts business in more than a 150 countries. Direct central funding of certain activities is a normal part of support for many smaller markets. In the case of Greece the Novartis Pharmaceuticals Division stopped centrally funding business activities nearly six years ago. These activities included direct payments to local third-party recipients in Greece. We are currently reviewing these historic payments as part of our internal inquiries. • The ISPOR trip was a multi-sponsored activity in which Novartis participated as one of the sponsors. It was not a Novartis-only event.

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Scenario planning


Local financial & political developments

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SCENARIO

APPROACH

KEY MESSAGES

1. Greek government fails in its negotiations with creditors. Possible results include further fierce measures to be agreed upon, or that the evaluation that is pending does not conclude on time.

• Proactive communication with SFEE, passing on key messaging that key members can mention in background discussions; reactive communication with other industry stakeholders. • Proactive communication with KOLs among HCPs, patients and policymakers to correct media misinformation • Evaluate possible proactive outreach with TIER 1 political / business stakeholders to attempt to limit mentions in the anti-corruption narrative

• • • •

2. Political developments with early elections being a likely scenario following the difficulties of the government in the current negotiations with the creditors.

High standards of ethical business conduct Internal processes initiated about allegations Current status of procedure Explanatory messaging about pricing issue and how the amounts mentioned by the media are not real

Both of these scenarios may result in a need for the government to publicly raise other issues (such as their fight against corruption) in order to counter balance public opinion, hence increasing possibility for an issue-related spike in public discussions.

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Issue-specific scenarios

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SCENARIO

APPROACH

KEY MESSAGES

3. Subpoena Received

• Proactive communication with SFEE, passing on key messaging that key members can mention in background discussions; reactive communication with other industry stakeholders. • Proactive communication with KOLs among HCPs, patients and policymakers to correct media misinformation

• Novartis [has received/has yet to receive] the subpoena] • The company’s investigation is ongoing. • We are fully cooperating with requests from local and foreign authorities. • Novartis is committed to the highest standards of ethical business conduct and regulatory compliance in all aspects of its work.

4. Indictment against Novartis Greece

• Proactive communication with SFEE, passing on key messaging that key members can mention in background discussions; reactive communication with other industry stakeholders. • Proactive communication with KOLs among HCPs, patients and policymakers to correct media misinformation

• Messages in this scenario will be determined by the status of the company’s investigation and how far the company can go in communicating a defense upon indictment.

5. Connection made to Serres case

• Reactive communication with all PA stakeholders

• Novartis is not a defendant in the Serres case. • The Serres case is separate and unrelated from the recent media reports about business practices in Greece.

6. Settlement with the government

• Approach will be determined based on terms of settlement and possible agreement with the government on coms approach • There might be a need in this case for selective unofficial briefings

• Messages will be determined by the settlement terms and will reiterate the company’s commitment to ethics and compliance.

Note: In all scenarios Novartis should conduct briefings with employees to correct misinformation, provide the sales team with a toolkit to address HCPs and continue formal legal communications in accordance with the litigation strategy Business Use Only

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Issue-specific scenarios (cont.)

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SCENARIO

APPROACH

KEY MESSAGES

7. Leak from competition increases suspicions

• Reactive communication

• Novartis’ investigation is ongoing. • We are fully cooperating with requests from local and foreign authorities. • Novartis is committed to the highest standards of ethical business conduct and regulatory compliance in all aspects of its work.

8. HCPs claim allegations are truthful

• Proactive meetings with HCP organizations • Reactive communication with all other external stakeholders

• Novartis’ investigation is ongoing. • We are fully cooperating with requests from local and foreign authorities. • Novartis is committed to the highest standards of ethical business conduct and regulatory compliance in all aspects of its work.

9. Group of HCPs stop prescribing Novartis

• Direct engagement with HCPs • Reactive approach to all other PA stakeholders

• Novartis is aware of the decision by certain HCPs. • We do not believe decreasing patient access to treatments is an appropriate action. • Our first priority is always assuring patients have access to the medicines they rely upon. We will work with healthcare providers and the MoH to ensure patients are not harmed by this decision.

Note: In all scenarios Novartis should conduct briefings with employees to correct misinformation, provide the sales team with a toolkit to address HCPs and continue formal legal communications in accordance with the litigation strategy Business Use Only

25

Public Affairs


Pharma sector policy events

Privileged and confidential

SCENARIO

APPROACH

KEY MESSAGES

10. MoH freezes additions to positive list

• Immediately evaluate the effect on patients • Official letters and personal meetings with key decision makers at MoH • Solicitation of support from HCPs

• Novartis is aware that the MoH has taken certain actions with respect to our medicines. • We are working to assess our options as well as the possible effect on patients. • Our first priority is always assuring patients have access to the medicines they rely upon. We will work with healthcare providers and the MoH.

11. Disclosure discussion raised again, causing a spike in Novartis case mentions

• Proactive communication with SFEE, passing on key messaging that key members can mention in background discussions; reactive communication with other industry stakeholders. • Proactive communication with KOLs among HCPs, patients and policymakers to correct media misinformation

• Novartis’ investigation is ongoing. • We are fully cooperating with requests from local and foreign authorities. • Novartis is committed to the highest standards of ethical business conduct and regulatory compliance in all aspects of its work. • Additional messaging on disclosure

Note: In all scenarios Novartis should conduct briefings with employees to correct misinformation, provide the sales team with a toolkit to address HCPs and continue formal legal communications in accordance with the litigation strategy Business Use Only

26

Public Affairs


Public Affairs

Stakeholders mapping and possible approach


Stakeholders mapping

Privileged and confidential

The following slides include an analytical stakeholders mapping in two different clusters. • slides 29 to 43 include a detailed listing of political stakeholders, while Please note that political stakeholders refers only to politicians, elected MPs and MEPs and is the team of stakeholders for which no action is suggested at this point.

• slides 44 to 64 include business related stakeholders Details on the impact of each stakeholder, priority of engagement, reason why and type of approach are also included in the slides to follow. Important note: • TIER refers to stakeholders’ impact on public opinion • PRIORITY refers to importance in terms of engagement

28

Public Affairs

Business Use Only


Stakeholders mapping Cluster 1 – Political stakeholders

Privileged and confidential

Political stakeholders

Opposition parties

Government

Health

Judicial Bodies

Other KOLs

Party Leaders & key consultants

Previous administrations

Ministry

Minister of Justice Public Prosecutors Presidents of Court, etc.

Government executives and consultants

New Democracy, PASOK, To Potami Enosi Kentroon

Ministers of

Previous Health Former Presidents of EOF, EOPYY, SFEE, etc.

Note: Please note that this cluster includes only politicians, elected MPs, MEPs 29

Public Affairs

Business Use Only

Shadow Ministers

Other KOLs

Shadow Ministers of Health, Justice New Democracy PASOK To Potami Enosi Kentroon

MPs or MEPs with high impact on public opinion


Cluster 1 – Political stakeholders GOVERNMENT – HEALTH BODY

WHO NAME AND TITLE

Ministry of Health

Andreas Xanthos – Minister of Health

1

2

Ministry of Health

P. Polakis Alternate Minister of Health

1

2

Ministry of Health

Giannis Baskozos General Secretary

1

2

Ministry of Health

G. Giannopoulos General Secretary

2

2

Business Use Only

30

Public Affairs

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Privileged and confidential


Cluster 1 – Political stakeholders

Privileged and confidential

GOVERNMENT – JUDICIAL BODIES (1/2) BODY

WHO

Ministry of Justice

Stavros Kontonis Minister of Justice

1

2

Ministry of Justice

Dimitris Papagelopoulos Alternate Minister of Justice for corruption issues

2

2

2

2

1

2

1

2

Ministry of Justice

Ministry of Justice Ministry of Justice

31

Public Affairs

George Sarlis General Secretary of the Ministry of Justice, Transparency &Human Rights Eftihis Fytrakis General Secretary of Criminal Policy Maria Giannakaki Secretary General of Transparency and Human Rights

Business Use Only

TIER (impact in public opinion)

PRIORITY (in terms of engagement)


Cluster 1 – Political stakeholders

Privileged and confidential

GOVERNMENT – JUDICIAL BODIES (2/2) BODY

WHO

Public Prosecutor Supreme Civil and criminal court of Greece Supreme Court Court of Audit Public Prosecutors

32

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Eleni Raikou Corruption Prosecutor Vasiliki Thanou President

1

2

1

2

Nikolaos Sakellariou President Androniki Theotokatou President

2

2

2

2

Ioannis Dragatis Deputy Prosecutor of Financial Crime

2

2

Supreme Court

Xeni Dimitropoulou Vasilopoulou Public Prosecutor of the Supreme Court

2

2

Public Prosecutors

Panagiotis Athanasiou Prosecutor of Financial Crime

1

2

Public Affairs

Business Use Only


Cluster 1 – Political stakeholders

Privileged and confidential

GOVERNMENT – GOVERNMENTAL EXECUTIVES AND CONSULTANTS (1/3) BODY

33

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Alexis Tsipras Prime Minister

1

2

Prime Minister’s Cabinet

Dimitris Liakos Deputy Minister to the Prime Minister

2

2

Prime Minister’s Cabinet

Ioannis Dragasakis Vice President of the Government for Economic Issues

1

2

Prime Minister’s Cabinet

Christofors Vernardakis Minister of State, responsible for Coordinating Government Operations

2

2

Ministry of State

Alekos Flampouraris Minister of State, responsible for Daily Mandate

1

2

Ministry of State

Dimitris Tzanakopoulos Minister of State, Spokesman of the Government

1

2

Ministry of Administrative Reform

Olga Gerovasili Minister

1

2

Ministry of Administrative Reform

Dimitris Tsoukalas Deputy General Secretary

2

2

Public Affairs


Cluster 1 – Political stakeholders

Privileged and confidential

GOVERNMENT – GOVERNMENTAL EXECUTIVES AND CONSULTANTS (2/3) BODY

WHO

Ministry of Health

Raptis Legal counsel to P. Polakis

1

2

Influences Minister

Ministry of Health

Georgopoulos Counsel to the Minister Of Health

1

2

Influences Minister

Ministry of Health

Arahovitis Legal Counsel to P. Polakis

1

2

Influences Minister

Ministry of Justice

Sofia Theleriti Head of Minister’s Office

1

2

Influences Minister

Ministry for Digital Policy, Telecoms and Media

Nikos Pappas Minister

1

2

Influences PM

34

Public Affairs

Business Use Only

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

NOTES


Cluster 1 – Political stakeholders

Privileged and confidential

GOVERNMENT – GOVERNMENTAL EXECUTIVES AND CONSULTANTS (3/3) BODY

WHO

Ministry of Finance

Euclid Tsakalotos Minister of Finance

1

2

Ministry of Finance

George Chouliarakis Alternate Minister of Finance

1

2

Ministry of Finance

Katerina Papanatsiou Deputy Minister of Finance

1

2

Ministry of Finance

Konstantinos Christou Special Secretary of Financial Crime Police (SDOE)

1

2

35

Public Affairs

Business Use Only

TIER (impact in public opinion)

PRIORITY (in terms of engagement)


Cluster 1 – Political stakeholders

Privileged and confidential

OPPOSITION PARTIES – PARTY LEADERS & KEY CONSULTANTS BODY

WHO

New Democracy

Kyriakos Mitsotakis Party leader

1

2

Possible ally

New Democracy

Makarios Lazarides Counsel to N.D. party leader

1

2

Influences party leader

PASOK

Fofi Gennimata Party leader

1

2

Possible ally

PASOK

Manolis Othonas Counsel to PASOK party leader

1

2

Influences party leader

PASOK

Christos Protopappas Counsel to PASOK party leader

1

2

Influences party leader

TO POTAMI

Stavros Theodorakis Party leader

1

2

Possible ally

TO POTAMI

Lina Papadaki Counsel to TO POTAMI leader

1

2

Influences party leader

ENOSI KENTROON

Vassilis Leventis Party leader

1

2

Business Use Only

36

Public Affairs

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

NOTES


Cluster 1 – Political stakeholders

Privileged and confidential

OPPOSITION PARTIES – PREVIOUS ADMINISTRATIONS (1/6)

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Ministry of Health 28/08/2015 – 23/09/2015

Athanasios Dimopoulos Former Minister of Health

2

2

Ministry of Health 27/01/2015 – 28/08/2015

Panagiotis Kouroumplis Former Minister

2

2

NOTES

A. Xanthos (was Deputy Minister)

37

Ministry of Health 27/01/2015 – 28/08/2015

Spiros Kokkinakis Former General Secretary Giannis Baskozos (was Secretary General)

2

2

Ministry of Health 10/06/2014 – 27/01/2015

Makis Voridis Former Minister of Health

2

2

Ministry of Health 10/06/2014 – 27/01/2015

Leonidas Grigorakos Katerina Papakosta Former Deputy Ministers

2

2

Ministry of Health 10/06/2014 – 27/01/2015

Vassilis Kontozamanis Former Secretary General

2

2

Ministry of Health 25/06/2013 – 10/06/2014

Adonis Georgiadis Former Minister of Health

1

0

Public Affairs

No contact Specifically mentioned as allegedly implicated


Cluster 1 – Political stakeholders

Privileged and confidential

OPPOSITION PARTIES – PREVIOUS ADMINISTRATIONS (2/6)

38

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Ministry of Health 28/08/2015 – 23/09/2015

Zeta Makri, Antonis Mpezas Former Deputy Ministers

2

2

Ministry of Health 28/08/2015 – 23/09/2015

Antonis Dimopoulos Former Secretary General

2

2

Ministry of Health 28/08/2015 – 23/09/2015

Andreas Lykourentzos Former Minister of Health

2

2

Ministry of Health 28/08/2015 – 23/09/2015

Marios Salmas Fotini Skopouli Former Deputy Minister

2

0

Ministry of Health 28/08/2015 – 23/09/2015

Antonis Dimopoulos Former Secretary Digital

2

2

Ministry of Health 17/05/2012 – 21/06/2012

Christos Kittas Former Minister of Health

2

2

Ministry of Health 7/09/2010 – 17/05/ 2012

Andreas Loverdos Former Minister of Health

1

2

Ministry of Health 7/09/2010 – 17/05/ 2012

Markos Mpolaris Michalis Timosidis Dimitris Mpartzopoulos Former Deputy Ministers

2

2

Public Affairs

NOTES

No contact – mentioned as playing a role in decision making during the period in question


Cluster 1 – Political stakeholders

Privileged and confidential

OPPOSITION PARTIES – PREVIOUS ADMINISTRATIONS (3/6)

39

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Ministry of Health 7/09/2010 – 17/05/ 2012

Antonis Dimopoulos Former Secretary General

2

2

Ministry of Health 7/10/2009 – 7/09/ 2010

Mariliza Xenogiannakopoulou Former Minister of Health

2

2

Ministry of Health 7/10/2009 – 7/09/ 2010

Fofi Gennimata, Michalis Timosidis, Christos Aidonis Former Deputy Ministers

2

2

Ministry of Health 7/10/2009 – 7/09/ 2010

Antonis Dimopoulos Former Secretary General

2

2

Minister of Health 15/02/2006 – 7/10/2009

Dimitris Avramopoulos Former Minister of Health

1

0

Minister of Health 15/02/2006 – 7/10/2009

Georgios Papageorgiou, Georgios Konstantopoulos, Marios Salmas Former Deputy Ministers

2

2

Minister of Health 15/02/2006 – 7/10/2009

Aristidis Kalogeropoulos Former Secretary General

2

2

Public Affairs

WHY

No contact Photographed as allegedly implicated


Cluster 1 – Political stakeholders

Privileged and confidential

OPPOSITION PARTIES – PREVIOUS ADMINISTRATIONS (4/6)

40

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

WHY

Ministry of Health 1993-1996

D. Kremastinos Former Minister of Health

1

2

Has already made negative statement

EOF National Medications Association 2004-2008

Dimitris Vagionas Former EOF President

2

2

EOF National Medications Association 2010-2013

Ioannis Tountas Former EOF President Academia

2

2

EOF National Medications Association 2013

Athanassios Giannopoulos Former EOF President

2

2

EOF National Medications Association 2013-2015

Dimitris Lintzeris Former EOF President

2

0

Panhellenic Union of Pharmaceutical Industry 2006-2008

Theodore Tryfon Former and Current PEF President

2

2

Public Affairs

No contact Allegedly implicated


Cluster 1 – Political stakeholders

Privileged and confidential

OPPOSITION PARTIES – PREVIOUS ADMINISTRATIONS (5/6)

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement )

Dimitrios Dimos Former PEF President

2

2

SFEE - Hellenic Association of Pharmaceutical Industries 2006-2012

Dimitrios Filiotis Former SFEE President

2

2

SFEE - Hellenic Association of Pharmaceutical Industries 2012-2015

Konstantinos Frouzis Former SFEE President

2

2

Pricing Committee 2012

Nikos Karapanos Member of the Committee Ministry of Health Counsel

2

0

Pricing Committee 2012

Zoi Dede President

2

2

Pricing Committee 2013

Dimosthenis Bouros President

2

2

Pricing Committee 2013

Vasileios Kontozamanis President

2

2

D. Kouvelas Former President Professor of Pharmacology

2

2

Panhellenic Union of Pharmaceutical Industry (ΠΕΦ) 2008-2014

Positive list Committee (ADD YEAR)

41

Public Affairs

NOTES

No contact Allegedly involved


Cluster 1 – Political stakeholders

Privileged and confidential

OPPOSITION PARTIES – SHADOW MINISTERS

42

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

NEW DEMOCRACY

Vasilis Economou Shadow Minister of Health

2

2

NEW DEMOCRACY

Pashalis Bouhoris Former Secretary of Ministry of Health Health Sector

2

2

NEW DEMOCRACY

Nikos Panagiotopoulos Shadow Minister of Justice

2

2

PASOK

Evi Christophilopoulou Head of PASOK Health Sector

2

2

PASOK

Kostas Skandalidis Shadow Minister of Justice

2

2

TO POTAMI

Sotiris Koupidis Shadow Minister of Health

2

2

TO POTAMI

Spyros Likoudis Shadow Minister of Justice

2

2

Public Affairs

NOTES


Cluster 1 – Political stakeholders

Privileged and confidential

OPPOSITION PARTIES – OTHER KOLs

43

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

NOTES

MEP

Stelios Kouloglou

1

2

Has already made negative statement

MEP

Eva Kaili

1

2

Public Affairs


Stakeholders mapping Cluster 2 – Business stakeholders

Privileged and confidential

Business stakeholders

Medical & Pharma Associations

44

Public Affairs

Academia

Industry Associations & Embassies

Patients associations

Public Officials


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – MEDICAL AND PHARMA ASSOCIATIONS (1/7)

45

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Panhellenic Medical Association (ΠΙΣ)

Mihcalis Vlastarakos President Member of EOPYY BoD

2

1

Panhellenic Medical Association (ΠΙΣ)

Konstantinos Giannakopoulos Vice President A’

2

1

Panhellenic Medical Association (ΠΙΣ)

Konstantinos Koutsopoulos Vice President B’

2

1

Panhellenic Medical Association (ΠΙΣ)

Dimitrios Varnavas Secretary General

2

1

Athens Medical Association

Giorgos Patoulis President

1

1

Athens Medical Association

Evripidis Bilirakis Vice President

2

1

Athens Medical Association

Alexios Vasileiou Secretary General

2

1

Athens Medical Association

Fotis Patsourakos Treasurer

2

1

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – MEDICAL AND PHARMA ASSOCIATIONS (2/7)

46

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Thessaloniki Medical Association

Ath. Exadaktilos President

2

1

Thessaloniki Medical Association

N. Batzios Vice President

2

1

Thessaloniki Medical Association

M. Hatzidimitriou Vice President

2

1

Thessaloniki Medical Association

N. Ntitsas Secretary General

2

2

Athens Medical Society

Grigorios Kouraklis President

2

1

Athens Medical Society

Sokratis Papageorgiou Vice President

2

1

Athens Medical Society

Eleftherios Thireos Secretary General

2

2

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – MEDICAL AND PHARMA ASSOCIATIONS (3/7)

47

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Hellenic Society for the Study and Research of Heart Failure

Gerasimos Filippatos President

2

2

Hellenic Society for the Study and Research of Heart Failure

Stamatis Adamopoulos Vice President A

2

2

Hellenic Society for the Study and Research of Heart Failure

Filippos Triposkiadis Vice President B

2

2

Hellenic Society for the Study and Research of Heart Failure

Antonios Sideris Secretary General

2

2

Hellenic Society of Hematology

Panagiotis Panagiotidis President

2

2

Hellenic Society of Hematology

Elissavet Grouzi Vice President

2

2

Hellenic Society of Hematology

Evaggelos Terpos Vice President

2

2

Hellenic Society of Hematology

Ioannis Batsis Secretary General

2

2

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – MEDICAL AND PHARMA ASSOCIATIONS (4/7)

48

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Hellenic Society of Medical Oncology

B. Georgoulias President

2

1

Hellenic Society of Medical Oncology

A. Ardabanis Vice President

2

1

Hellenic Society of Medical Oncology

A. Athanasiadis Secretary General

2

1

Hellenic Society of Medical Oncology

I. Mpoukoubinas Secretary Special

2

1

Hellenic Society of Medical Oncology

I. Varthalitis Treasurer

2

1

Pharmaceutical Association of Attica & Panhellenic Pharmacists Association

K. Lourantos President

1

1

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – MEDICAL AND PHARMA ASSOCIATIONS (5/7)

49

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Panhellenic Pharmacists Association (Πανελλήνιος Φαρμακευτικός Σύλλογος)

Io. Makrigiannis Secretary General

2

1

Panhellenic Pharmacists Association

Ap. Baltas Vice President A’

2

1

Panhellenic Pharmacists Association

An. Sofianopoulos Vice President B’

2

1

Pharmacist's Supplying Cooperative of Attica (PRO.SY.F.A.P.E.)

Andreas Galanopoulos President

2

1

Pharmacist's Supplying Cooperative of Attica (PRO.SY.F.A.P.E.)

Miltos Agioump Vice President

2

1

Pharmacist's Supplying Cooperative of Attica (PRO.SY.F.A.P.E.)

Dimitris Triantafyllidis Secretary General

2

1

Panhellenic Pharmacists Union (Πανελλήνια Ένωση Φαρμακοποιών)

N. Colman President

2

1

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – MEDICAL AND PHARMA ASSOCIATIONS (6/7)

50

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Hellenic Society of Dermatology and Veneorology

D. Rigopoulos President

2

1

Hellenic Society of Dermatology and Veneorology

I. Bakris Vice President

2

2

Hellenic Society of Dermatology and Veneorology

H. Haidemenos Secretary General

2

2

Hellenic Cardiological Society

K. Tsioufis President

2

1

Hellenic Cardiological Society

Ioannis Goudevenos Vice President

2

1

Hellenic Cardiological Society

S. Foussas Hon. President

2

2

Hellenic Cardiological Society

I.Kanakakis Secretary General

2

2

PhRMA Innovation Forum (PIF)

Jim Sage, President

2

1

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – MEDICAL AND PHARMA ASSOCIATIONS (7/7)

51

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Panhellenic Pharmacists Union

D. Panidis Vice President A’

2

1

Panhellenic Pharmacists Union

K. Girtis Vice President B’

2

1

Panhellenic Pharmacists Union

Al. Tsitomeneas Secretary

2

1

Pharmaceutical Association of Attica

K. Manolopoulos Vice President

2

1

Pharmaceutical Association of Attica

Ilias Giannoglou Secretary General

2

1

Pharmaceutical Association of Attica

M. Moshonas Treasurer

2

Public Affairs

1

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – ACADEMIA (1/2)

52

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

NOTES

University of Athens

G. Yfantopoulos Professor

2

0

No contact Allegedly involved

University of Peloponese

M. Geitona Associate Professor

2

0

No contact Allegedly involved

National School of Public Health

N. Maniadakis Professor

2

0

No contact Allegedly involved

University of Peloponese

K. Souliotis Associate Professor

2

TBC

University of Athens New Democracy

L. Liaropoulos Professor

2

TBC

Public Affairs


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – ACADEMIA (1/2)

53

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

National School of Public Health

K. Athanasakis Professor

2

2

University of Peloponese

G. Kiriopoulos Emeritus Professor

2

2

University of Athens

Ag. Hatzakis Professor

2

2

London School of Economics

P. Kanavos Professor

2

2

TBC

D. Lamprelli

2

0

Public Affairs

NOTES

No contact Allegedly involved


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – INDUSTRY ASSOCIATIONS (1/5)

54

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Hellenic Association of Pharmceutical Companies (SFEE)

Pashalis Apostolidis President

2

1

Hellenic Association of Pharmceutical Companies (SFEE)

K. Panagoulias Vice President

2

1

Hellenic Association of Pharmceutical Companies (SFEE)

K. Kofinas Secretary General

2

1

Hellenic Association of Pharmceutical Companies (SFEE)

N. Varelas Treasurer

2

1

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – INDUSTRY ASSOCIATIONS (2/5)

55

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Hellenic Federation of Enterprises (SEV)

Theodoros Fessas President

1

2

Hellenic Federation of Enterprises (SEV)

J. Giotis Vice President

2

2

Hellenic Federation of Enterprises (SEV)

Sp. Theodoropoulos Vice President

2

2

Hellenic Federation of Enterprises (SEV)

A. Kallintsantsis Vice President

2

2

Hellenic Federation of Enterprises (SEV)

N. Karamouzis Vice President

2

2

Hellenic Federation of Enterprises (SEV)

E. Mytilineos Vice President

2

2

Hellenic Federation of Enterprises (SEV)

D. Papalexopoulos Vice President

2

2

Hellenic Federation of Enterprises (SEV)

Al. Makridis Secretary General

2

2

Hellenic Federation of Enterprises (SEV)

K. Maragos Treasurer

2

2

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – INDUSTRY ASSOCIATIONS (3/5)

56

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Foundation for Economic and Financial Research (ΙΟΒΕ)

T. Athanassopoulos Chairman

1

2

Foundation for Economic and Financial Research (ΙΟΒΕ)

N. Vettas Director General

1

2

Foundation for Economic and Financial Research (ΙΟΒΕ)

P. Thomopoulos B Deputy Chairman

2

2

Foundation for Economic and Financial Research (ΙΟΒΕ)

E. Kalousis C Deputy Chairman

2

2

Foundation for Economic and Financial Research (ΙΟΒΕ)

Ath. Savvakis Secretary General

2

2

Foundation for Economic and Financial Research (ΙΟΒΕ)

Jenny Tsoumani Treasurer

2

2

Athens Chamber of Commerce and Industry (EBEA)

K. Mihalos President

1

2

Athens Chamber of Commerce and Industry (EBEA)

Y. Syngelidis 1st Vice President

2

2

Athens Chamber of Commerce and Industry (EBEA)

P. Thologlou 2nd Vice President

2

2

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – INDUSTRY ASSOCIATIONS (4/5)

57

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Athens Chamber of Commerce and Industry (EBEA)

N. Sofianos Secretary General

2

2

Athens Chamber of Commerce and Industry (EBEA)

E. Tsogis Treasurer

2

2

Hellenic Statistical Authority (ELSTAT)

At. Thanopoulos President

1

2

American – Hellenic Chamber of Commerce

Simos Anastasopoulos President

1

2

American – Hellenic Chamber of Commerce

N. Bakatselos Vice President

2

2

American – Hellenic Chamber of Commerce

M. Kyriakou Vice President

2

2

American – Hellenic Chamber of Commerce

Litsa Panagiotopoulou Secretary General

2

2

American – Hellenic Chamber of Commerce

Thanos Papadopoulos Treasurer

2

2

US Embassy in Greece

Geoffrey R. Pyatt Ambassador

1

2

US Embassy in Greece

Bryan Larson, Commercial Counselor

2

2

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – INDUSTRY ASSOCIATIONS (5/5)

58

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Swiss Embassy in Greece

Dr Hans-Rudolf Hodel Ambassador

2

2

Swiss Embassy in Greece

Commercial Counselor

2

2

Public Affairs

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – PUBLIC OFFICIALS (1/3)

59

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Hellenic Diabetes Federation

Tedolouris Nikolaos, President

3

2

Hellenic Diabetes Federation

Ioannides Konstantinos, 1st Vice President

3

2

Hellenic Diabetes Federation

Vlastaris Sofoklis, 2nd Vice President

3

2

Multiple Sclerosis Association Hellas

Maraka Vasiliki, President

3

2

Multiple Sclerosis Association Hellas

Vrieniou Aliki, Vice President

3

2

ELEANA, Hellenic Antirheumatic Association

Pappa Athanasia, President

3

2

ELEANA, Hellenic Antirheumatic Association

Papastavrou Theodora, Vice President

3

2

Kalypso, PSO Group

Loumos Kostas, President

3

2

Kalypso, PSO Group

Papalexi Maria, Vice President

3

2

Public Affairs

Business Use Only

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – PATIENT ASSOCIATIONS (2/3)

60

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Kalypso, PSO Group

Mikedaki Mary, General Secretary

3

2

Epidermia, Pan-Hellenic Association of PSO&PSA patients

Koukopoulou Tina, President

3

2

Epidermia, Pan-Hellenic Association of PSO&PSA patients

Vamvakousis Renos,Vice President

3

2

KEFI, Association of Cancer Patients, Friends & Doctors

Grammatoglou Zoi, President

3

2

KEFI, Association of Cancer Patients, Friends & Doctors

Hinari Maria, Vice President

3

2

KEFI, Association of Cancer Patients, Friends & Doctors

Holeva Eirini, General Secretary

3

2

Association of Volunteers against Cancer

Haldaiou – Mitrou Olympia, President

3

2

Association of Volunteers against Cancer

Korleti Manio, Vice President

3

2

Association of Volunteers against Cancer

Pashalaki Stavroula, General Secretary

3

2

Public Affairs

Business Use Only

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – PATIENT ASSOCIATIONS (3/3)

61

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Alma Zois, Pan-Hellenic Association of Women with Breast Cancer

Gavriilidou Kleopatra, President

3

2

Alma Zois, Pan-Hellenic Association of Women with Breast Cancer

Kourenta Eleftheria, Vice President

3

2

Greek Thalassemia Federation

Myrila Vana, President

3

2

Greek Thalassemia Federation

Manafas Ahileas, 1st Vice President

3

2

Greek Thalassemia Federation

Mihalaki Eleni, 2nd Vice President

3

2

Greek Alliance of Rare Diseases

Lamprou Marianna, President

3

2

Greek Alliance of Rare Diseases

Drakoulis Giannoukakos, Vice President

3

2

Public Affairs

Business Use Only

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – PUBLIC OFFICIALS (1/3)

62

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

EOF, National Organization for Medicines

Makridaki Despina, 1st Vice President

2

1

EOF, National Organization for Medicines

Giannoglou Ilias, 2nd Vice President

2

1

IFET, Institute of Pharmaceutical Research & Technology

Pantazis Dimitris, CEO

2

1

Health Procurement Committee

Sartzetaki Petroula Anastasia, President

2

1

NGO – Save Greece from Cancer – EOPYY(?)

Arahovitis Vasilis, Legal Councel

2

1

E Government of Social Security

Tagaris Anastasios, President &CEO

2

1

E Government of Social Security

Triantafilidi Athina, Director of Applications’ Operation & Support

2

1

EOPYY

Galanakis Konstantinos, President’s consultant

2

1

EOPYY

Athanasiadis Kyriakos, President’s consultant

2

1

Public Affairs

Business Use Only

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – PUBLIC OFFICIALS (2/3)

63

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

Committee of Prescribed Medicines

Kouvelas Dimitris, President

2

1

Committee of Medicines Pricing

Filos Giannis, President

2

1

Hippocratio General Hospital

Mpalasopoulou Anastasia, Director

2

1

Agios Savvas Hospital

Dendramis Georgios, Director

2

1

ESAMEA

Leontopoulos Grigoris, Vice President

2

1

1st Health Region ATTICA

Papadopoulos Aggelos, Director

2

1

2nd Health Region Piraeus & Aegean

Iordanidou Olga, Director

2

1

3rd Health Region Macedonia

Kirkos Georgios, Director

2

1

4th Health Region Macedonia & Thrace

Hatzigerakoudis Eustathios, Director

2

1

Public Affairs

Business Use Only

NOTES


Cluster 2 – Business Stakeholders

Privileged and confidential

BUSINESS STAKEHOLDERS – PUBLIC OFFICIALS (3/3)

64

BODY

WHO

TIER (impact in public opinion)

PRIORITY (in terms of engagement)

5th Health Region Thessaly and Central Greece

Antoniou Nestoras, Director

2

1

6th Health Region Peloponnese, Ionian Islands, Ipiros & Western Greece

Giannopoulos Georgios, Director

2

1

7th Health Region Crete

Mavromati Eleni, Director

2

1

Public Affairs

Business Use Only

NOTES


Public Affairs

APPENDIX


Recent milestones in healthcare policy

Privileged and confidential

• 2006 : Abolition of the Positive List in May. From April 2006 to December 2009, all prescribed medicinal products were reimbursed automatically. • 2005 : Change in Pricing System. A new product’s price approval is based on the average of the 3 lowest prices in EU and more specifically 2 countries with lowest price that are members of the EU (incl. Switzerland) before 01.05.2004 and 1 country out of 10 that are members of the EU after May 1st 2004. (previously price was determined on the lowest price of the EU countries decreased by 7%). • 2009 : Change in Pricing System. A new product’s price approval is now based on the average of the lowest price of the EU countries (Switzerland is excluded). • 2010 : Reintroduction of the Positive List in January 2010. Definition of Reimbursement criteria and reference price (based on retail prices of original products and Gxs). • 2011 : Introduction of rebate : -4% on ex-factory price for prescribed pharmaceutical products and -5% discount on invoice applied on hospital price for prescribed pharmaceutical products sold in hospitals. (amendments on rebates were made thereafter e.g volume rebate) • Since April 2011 MoH has held responsibility for establishing and monitoring prices of medicinal products. Previously, the price setting of new pharmaceuticals fell within the remit of the Ministry of Development • 2012: – The National Organization for Healthcare Provision (EOPYY): formed on January 1st through the merger of the health-related functions of the five largest social insurance funds. EOPYY activates under the legislative umbrella of Ministry of Health. – Establishment of electronic prescribing. All doctors are obliged to prescribe medicines through the online/electronic platform designed by state body “IDIKA SA” (legislative authority: Ministry of Labour & Social Security) – Introduction of clawback in addition to sales volume rebate. The industry is liable for any monthly pharmaceutical overspend that exceeds one twelfth of the annual pharmaceutical budget. Clawback fee is based on MAH’s % MSh in the pharmaceutical spending. – Since October 2012 EOF has held responsibility for establishing and monitoring prices of medicinal products. Previously, the price setting of new pharmaceuticals fell within the remit of the YYKA’s (Ministry for Health and Social Solidarity) drug pricing committee. This committee (under current Ministry of Health) still retains responsibility for verifying prices approved by EOF prior to publication of a new drug price bulletin, as well as assessing manufacturers’ appeals against EOF pricing decisions.

66

Public Affairs

Business Use Only


Ministers of Health and Social Solidarity (2004–2015)

Privileged and confidential

Period

Minister

Deputy Minister

Secretary Generals

Party

10/03/2004 – 15/02/2006

Nikitas Kaklamanis

Athanasios Giannopoulos

Gianna Despotopoulou

New Democracy

15/02/2006 – 7/10/2009

Dimitris Avramopoulos

Georgios Papageorgiou, Georgios Konstantopoulos, Marios Salmas

Aristidis Kalogeropoulos

New Democracy

7/10/2009 – 7/09/ 2010

Mariliza Xenogiannakopoulou -

Fofi Gennimata, Michalis Timosidis, Christos Aidonis

Antonis Dimopoulos

Panhellenic Socialist Movement (PASOK)

7/09/2010 – 17/05/ 2012

Andreas Loverdos

Markos Mpolaris, Michalis Timosidis, Dimitris Mpartzopoulos

Antonis Dimopoulos

Panhellenic Socialist Movement (PASOK)

17/05/2012 – 21/06/2012

Christos Kittas

21/06/2012 – 25/06/2013

Andreas Lykourentzos

Marios Salmas, Fotini Skopouli

Antonis Dimopoulos

New Democracy

25/06/2013 – 10/06/2014

Adonis Georgiades

Zeta Makri, Antonis Mpezas

Antonis Dimopoulos

New Democracy

10/06/2014 – 27/01/2015

Makis Voridis

Leonidas Grigorakos, Katerina Papakostas

Vassilis Kontozamanis

New Democracy

Public Affairs

Independent


Privileged and confidential

Ministers of Health and Social Solidarity (2015 and onwards) Period

Minister

Deputy Minister

Secretary Generals

Party

27/01/2015 – 28/08/2015

Panagiotis Kouroumplis

Andreas Xanthos

Spiros Kokkinakis, Giannis Mpaskozos

Coalition of the Radical Left (Syriza)

28/08/2015 – 23/09/2015

Athanasios Dimopoulos

23/09/2015 - Present

Andreas Xanthos

Public Affairs

Independent

Pavlos Polakis

Giorgos Giannopoulos (replacing Giannoulatos in Dec after his resigning) Giannis Mpaskozos

Coalition of the Radical Left (Syriza)


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