Brain food A degustation menu for pharmaceuticals companies
1 st course Marketing The meaning and interpretation of misleading and deceptive conduct (Length: 1:00) Under Australian consumer law (the Competition and Consumer Act), the various State and Territory Fair Trading Acts, and the Medicines Australia Code of Conduct, pharmaceuticals companies are prohibited from engaging in misleading or deceptive conduct. In fact, they can be found to be liable even if the conduct has not actually misled anyone and the person making the representation acted honestly and reasonably. Audience: legal, risk, marketing, communications, brand, social media Comparative advertising and how to avoid misleading the market (Length: 0:30) While in Australia there is no statutory prohibition on the use of comparative advertisements, or the mention of competitor products in advertisements, there have been many instances where the courts have held that comparative advertising has been misleading or deceptive. This session will review the laws that affect the making of marketing claims, including a detailed examination of the use and misuse of comparative advertising as a means of communicating product differentiation, and the special rules and guidelines applicable under the Medicines Australia Code of Conduct. Audience: legal, risk, marketing, communications, brand, social media Risky business the fine line between ethics and bribery (Length: 0:30) Under anti-bribery legislation and the Medicines Australia Code, pharmaceutical companies face severe penalties if they are found to have blurred the line between marketing and bribery or improper influence. Most recently a US investigation resulted in a multi-billion dollar fine on a global pharmaceuticals entity for contravening the Foreign Corrupt Practices Act. What are the risks associated with soft inducements hospitality, charitable donations and other non-business activities in the pharmaceuticals sector? And what would be the impact of the introduction of legislation akin to the US Sunshine Act? Audience: board, executive, legal, risk, corporate affairs, communications, marketing, sales User-generated content subject to advertising standards (Length: 1:00) Pharmaceuticals companies may need to review their social media marketing of over-thecounter products in light of the Advertising Standards Board s 2012 decisions against VB and Smirnoff. In both cases, the Board determined the onus is on brand owners to take responsibility for user posts on their social media pages. This stance could well spill-over into healthcare professional forums, raising additional issues for the pharmaceutical sector. Audience: legal, risk, marketing, communications, brand, social media
2 nd course Governance, competition and regulation Competition issues in pharmaceuticals (Length: 1:00) Pharmaceutical commercial arrangements often raise complex competition issues, including long-term arrangements, joint ventures and the use of intellectual property protections. Moreover, the line between wholesaler, manufacturer, supplier and pharmacy is fast becoming blurred. This presentation will use case studies and anecdotes to demonstrate the key competition issues in the pharmaceutical sector. Audience: finance, commercial, legal Directors duties and corporate governance for wholly-owned Australian subsidiaries (Length: 1:00) Wholly-owned Australian subsidiaries are subject to unique corporate governance issues, for example affecting their reporting structures and the way in which their directors and executive managers are held to account. This session will consider the principles of good corporate governance. It will also serve as a refresher on directors duties and responsibilities under the Corporations Act and the Therapeutic Goods Act, examining the implications of the James Hardie and Centro decisions and the interpretation of the business judgment rule. Audience: board, executive, company secretary, legal Potential personal liabilities of in house counsel (Length: 1:00) As company officers, in-house counsel have always had some potential exposure to personal legal liability. But, post-enron, regulators in the US and beyond have looked to utilise counsels professional duties as a means of blocking illegal conduct by companies and of compelling disclosure when it does occur. At the same time, counsel who have been found to have facilitated breaches of the law have been held accountable civilly and criminally for failing in their professional duty to their employer to keep it from harm. This seminar looks at these developments and the increasingly onerous obligations on in-house counsel. Audience: board, executive, legal, risk, brand, corporate affairs, communications Issues in pricing: exploring the nooks and crannies of the PBS system (Length: 1:00) Getting an acceptable PBS listing is a make or break issue for new products. Understanding the system, how it works, how it is used, and how it may be used are essential for planning product strategies, both market entry and market preservation. This session will explore current issues in the space and contemplate what might lie ahead. Audience: board, executive, legal, corporate affairs, pricing and reimbursement.
2 nd course Governance, competition and regulation (continued) Anti-competitive business practices (Length: 0:30) Businesses involved in the sale and distribution of goods and services, whether through independent retailers or franchisees, must be ever-vigilant when it comes to avoiding conduct that may be deemed anti-competitive. This seminar examines how the various statutory prohibitions can apply to common supply arrangements if they are not managed correctly, and how risk of non-compliance can be minimised. Audience: executive, marketing, sales The extra-territorial reach of anti-corruption legislation (Length: 1:00) Multi-national pharmaceutical companies need to be mindful of the anti-corruption legislation that affects them by virtue of doing business across borders. It is particularly important to know when regulations affect one part of a group because another part of the group operates in a jurisdiction whose laws have extra-territorial effect. This session will highlight how corporations should best approach anti-corruption compliance, transactional and third party due diligence, and corruption investigations. It will also examine the related issues of anti-money laundering and whistle blowing. Audience: executive, legal, compliance, risk Integrated supply chain management of pharmaceutical and biotech products (Length: 1:00) The packaging and distribution of time and temperature sensitive shipments of pharmaceutical and biotech products is highly regulated and fraught with risk. Inventory management, contingency planning, safe handling, Good Manufacturing Practice (GMP) validation, warehousing, and chain of responsibility are among the many issues which require careful coordination. In contrast to transportation of goods by road where parties are free to contract on negotiated terms and conditions, carriage by sea and air is subject to its own liability regime. Although these regimes are based on international conventions, the implementation varies between countries. This seminar will present ways to achieve an integrated supply chain, and ensure security of goods, within the current domestic and international regulatory environments. Audience: logistics, legal, risk, compliance
3 rd course Commercial Transfer pricing (Length: 0:45) The global reach and profitability of pharmaceutical companies make them prime targets for allegations of transfer pricing. The US and many emerging markets are reviewing their approach to the tax treatment of overseas profits tightening their rules and increasing penalties for avoidance. Simultaneously, the Australian Federal Government has retrospectively introduced the first tranche of new legislation (Tax Laws Amendment (Cross- Border Transfer Pricing) Bill (No. 1) 2012) to ensure the effectiveness of transfer pricing rules contained in Australia s tax treaties. A second Bill will follow later this year and, armed with new and improved powers, a second review is almost to be expected. This session will update you on the latest developments in transfer pricing legislation. Audience: executive, legal, finance Electronic security and privacy protection (Length 1:00) With Australia moving into a system of electronic health records, the pharmaceutical and life sciences sectors face considerable technology-related challenges. At the same time, interaction between healthcare practitioners, pharmaceutical companies and patients is increasing, as is the frequency of outsourcing arrangements. All of these developments contribute to the need for data integrity, privacy protection and impenetrable information security. This session will consider the laws regarding the collection, storage and use of information, including as they apply to outsourcing and other third party arrangements. Audience: executive, legal, risk, compliance, information technology, procurement Commercial contracting in the pharmaceuticals sector (Length: 1:00) Contracts for pharmaceutical companies are often high risk, long term and for high value. The negotiation of these contracts and risk allocation within these documents are therefore crucial. In this session we will provide an update on recent contract law cases, including the latest on what best endeavours really means. We will also review risk allocation strategies, including indemnities, consequential loss and clauses setting out exclusions and limitation of liability. Audience: procurement, legal
3 rd course Commercial (continued) Negotiating the acquisition trail (Length: 0:45) The pharmaceutical sector is facing unprecedented challenges expiring patents, competition from generics, pricing and regulatory pressure are all forcing companies look closely at the bottom line. One effect of this onslaught has been an upsurge in the level of merger and acquisition activity as players consolidate to reshape product portfolios, cut costs, neutralise the competition, and penetrate new markets. This session will explore current M&A best practice, including the negotiation, documentation and due diligence of deals. Audience: executive, risk, legal Delivering on the product promise when you involve third parties (Length: 0:30) You cannot always control every step from factory to end customer. This session will discuss joint ventures, licensing, distributorships, franchising, e-commerce and other distribution channels, and how to get the structure and responsibilities right. It will consider the features, documentation and legal implications of the various channels to market, and the typical legal issues encountered with third parties as products travel from manufacturer to the end consumer. Audience: executive, marketing, sales, international managers Compulsory licensing of pharmaceutical patents (Length: 0:45) Consistent with Australia s obligations under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Protocol, the proposed Intellectual Property Laws Amendment Bill 2012 will impose additional licensing provisions on the manufacturers of drugs which require multiple patents. This seminar will introduce the proposed legislation. Audience: legal, risk Raising the bar: counting down to commencement of amended patent legislation (Length: 0:30) The Intellectual Property Laws Amendment ( Raising the Bar ) Act 2012, which comes into effect in April 2013, will implement stricter patentability and specification requirements for patent applications. This seminar will overview the key amendments and how they are likely to impact the pharmaceuticals sector in Australia. Audience: legal
3 rd course Commercial (continued) Combating generics: defence is the best offence (Length: 1:00) When a generic drug comes to market branded sales drop precipitously as much as 80 percent by the time a second- or third-generation generic arrives. That degree of market loss has led to an aggressive search for solutions, and resulted in creative research development and marketing strategies. This session will review some of the latest techniques being adopted by pharmaceutical firms in an effort to protect their best assets. It will also consider the impact of government intervention on pricing. Audience: legal, risk, marketing, research and development Modern day diversity challenges female-friendly pharma (Length: 0:45) Australia s current labour market is highly competitive and workforce participation forecasts are that there will be a labour shortage of 1.4 million workers by the end of this decade. This alarming statistic alone should be a catalyst for organisations to harness the potential of women in the workforce. In the pharmaceuticals sector, which has a significant proportion of female employees, flexible workplaces, and flexible work practices which include familyfriendly arrangements, will contribute to a company s ability to attract and retain valuable female workers. This seminar will explore current best practice in the design, structure and negotiation of flexible work arrangements. Audience: human resources, legal Best endeavours clauses (Length: 0:45) Clauses requiring parties to use best or reasonable endeavours are commonplace in pharmaceuticals contracts. They appeal at the time of contracting where typically there is goodwill and a belief that all parties will operate in good faith. On occasions when outcomes do not match expectations, a dispute may emerge necessitating that the courts grapple with the meaning of these uncertain obligations. This seminar will examine the recent interpretation of best and reasonable endeavours clauses, as well as some available contractual alternatives. Audience: legal, risk, compliance, procurement Clinical trials: doing them quickly and well (Length: 1:00) This will explore best practice in clinical trial execution, including ensuring documentation anticipates the myriad potential issues that can arise, and covering off the privacy requirements, both present and future, local and international. Audience: legal, research & development, regulatory
4 th course Disputes Patent ownership: protecting confidential information and intellectual property (Length: 0:45) A 2011 decision of the Australian Patent Office has highlighted the significance of an employee s job description in determining whether the employee has a duty to invent for the benefit of his or her employer. In this seminar, we outline the forms of intellectual property that the law protects, and the legal remedies and practical measures that can be used to access that protection. We will also consider the nature and extent of employees duties of loyalty and confidentiality, how potential breaches of those duties can be detected, and the steps that can be taken in response, including in relation to restraint of trade obligations due by both employees and company officers. Audience: legal, risk, executive How to use international arbitration to resolve disputes (Length: 0:45) Within the pharmaceuticals sector, licensing and marketing agreements as well as being high-risk, long-term, and for high value commonly involve parties in two or more countries. When a dispute arises, international arbitration is one means of resolving those issues which transcend national borders. This seminar explains why, and outlines both the critical elements of the process and the traps that can befall unwary participants. Audience: legal, risk, compliance, procurement Privilege: attracting it and losing it (Length: 0:45) Here we will examine the whole process of attracting legal professional privilege in a corporate setting, especially through internal corporate counsel. We will also provide guidance on how privilege may be lost or compromised through carelessness or inappropriate use of relevant information or documents. Audience: legal, risk, board Product liability issues for medicines and medical devices manufacturers (Length: 0:45) Increasingly, complication rates of medicines and medical devices are being recorded in registries and other databases. In this seminar we examine how registry and database information is being used by plaintiff lawyers to identify targets for mass product liability litigation. We also cover other recent developments in product liability including mandatory adverse event reporting under Australian consumer law. Audience: legal, risk, executive, medical, marketing