A population-based study on incidence, treatment, and survival in ampullary cancer in the Netherlands.

INTRODUCTION: Ampullary cancer is rare and as a result epidemiological data are scarce. The aim of this population-based study was to determine the trends in incidence, treatment and overall survival (OS) in patients with ampullary adenocarcinoma in the Netherlands between 1989 and 2016. METHODS: Patients diagnosed with ampullary adenocarcinoma were identified from the Netherlands Cancer Registry. Incidence rates were age-adjusted to the European standard population. Trends in treatment and OS were studied over (7 years) period of diagnosis, using Kaplan-Meier and Cox regression analyses for OS and stratified by the presence of metastatic disease. RESULTS: In total, 3840 patients with ampullary adenocarcinoma were diagnosed of whom, 55.0% were male and 87.1% had non-metastatic disease. The incidence increased from 0.59 per 100,000 in 1989-1995 to 0.68 per 100,000in 2010-2016. In non-metastatic disease, the resection rate increased from 49.5% in 1989-1995 to 63.9% in 2010-2016 (p < 0.001). The rate of adjuvant therapy increased from 3.1% to 7.9%. In non-metastatic disease, five-year OS (95% CI) increased from 19.8% (16.9-22.8) in 1989-1995 to 29.1% (26.0-31.2) in 2010-2016 (logrank p < 0.001). In patients with metastatic disease, median OS did not significantly improve (from 4.4 months (3.6-5.0) to 5.9 months (4.7-7.1); logrank p = 0.06). Cancer treatment was an independent prognostic factor for OS among all patients. CONCLUSION: Both incidence and OS of ampullary cancer increased from 1989 to 2016 which is most likely related to the observed increased resection rates and use of adjuvant therapy.

Ascertainment of cancer in longitudinal research: The concordance between the Rotterdam Study and the Netherlands Cancer Registry.

Complete and accurate registration of cancer is needed to provide reliable data on cancer incidence and to investigate aetiology. Such data can be derived from national cancer registries, but also from large population-based cohort studies. Yet, the concordance and discordance between these two data sources remain unknown. We evaluated completeness and accuracy of cancer registration by studying the concordance between the population-based Rotterdam Study (RS) and the Netherlands Cancer Registry (NCR) between 1989 and 2012 using the independent case ascertainment method. We compared all incident cancers in participants of the RS (aged ≥45 years) to registered cancers in the NCR in the same persons based on the date of diagnosis and the International Classification of Diseases (ICD) code. In total, 2,977 unique incident cancers among 2,685 persons were registered. Two hundred eighty-eight cancers (9.7%) were coded by the RS that were not present in the NCR. These were mostly nonpathology-confirmed lung and haematological cancers. Furthermore, 116 cancers were coded by the NCR, but not by the RS (3.9%), of which 20.7% were breast cancers. Regarding pathology-confirmed cancer diagnoses, completeness was >95% in both registries. Eighty per cent of the cancers registered in both registries were coded with the same date of diagnosis and ICD code. Of the remaining cancers, 344 (14.5%) were misclassified with regard to date of diagnosis and 72 (3.0%) with regard to ICD code. Our findings indicate that multiple sources on cancer are complementary and should be combined to ensure reliable data on cancer incidence.

The Trans-Pacific Partnership agreement: a test for health diplomacy

Against the background of stalled negotiations in the World Trade Organization (WTO), there has been a proliferation of bilateral and regional trade agreements. Most of these contain provisions which go beyond existing WTO agreements in the protection of intellectual property (IP), and raise concerns about the ability of low and middle-income countries to provide affordable drugs for their populations. An extreme case is the Trans-Pacific Partnership Agreement (TPPA), now under negotiation among eleven countries. Competing interests within and among countries, evolving alliances and economic ties, and external factors present a challenge for health diplomacy at the intersection of health and trade. With the emergence of new economic power centres, low and middle-income countries have wider choice for trade partnerships and do not have to accept agreements that are incompatible with their policy objectives. The situation calls for a more sophisticated and inclusive style of health diplomacy than we have seen up to now.

International jurisprudence on trade and environmental health: one step forward, two steps back?

Since the creation of the World Trade Organization (WTO), there has been considerable debate regarding the impact of its rules on public health. By contrast, the role of the WTO dispute settlement mechanism has received little attention, even though the bodies responsible for settling disputes are the ultimate interpreters of WTO rules and agreements. To date, three WTO disputes that relate to occupational and/or environmental health have been fully litigated. A review of the decisions and reasoning in these cases indicates that WTO jurisprudence is evolving, as Panels and the Appellate Body try--with varying degrees of success--to balance countries' rights and obligations under international trade agreements with their right to protect occupational and environmental health. Disputes between nations can have an impact beyond the parties concerned, and raise questions about the relationship between trade agreements and other international agreements, especially multilateral environmental agreements (MEAs).

Harmonization, regulation, and trade: interactions in the pharmaceutical field.

This article aims to draw attention to the process of harmonization of requirements for drug registration (the so-called ICH process) and to examine how it may affect access to medicines in developing countries. The ICH process, especially when seen in conjunction with the World Trade Organization's Agreement on Technical Barriers to Trade, may create additional barriers to would-be entrants on the global pharmaceutical market, notably large generic manufacturers in developing countries-the very companies that can create credible price competition for the innovative industry and, thus, increase access to medicines. These barriers could help maintain the status quo by insulating well-established companies from competition, thereby forming a further obstacle to lower drug prices and to access to medicines, especially in developing countries. Developing countries should therefore carefully consider the implications of the positioning of ICH standards as global standards, and be vigilant with regard to their possible incorporation, whether explicitly or not, in international trade agreements.

Developing countries and trade in health services: which way is forward?

International trade in health services appears to be increasing It may receive a further boost when liberalized and bound under international trade agreements, such as the General Agreement on Trade in Services (GATS). Liberalization of trade in health services can create opportunities, but may also exacerbate preexisting problems. Moreover, once liberalization is locked in under international trade agreements, reversing policies becomes difficult, especially for developing countries. Making undue commitments to liberalize health services under GATS may therefore result in the loss of policy space. Yet the GATS agreement contains considerable flexibility to fine-tune commitments in accordance with national (health) objectives. But flexibility entails complexity, and for GATS the complexity is compounded by the fact that some of its rules are still being developed. Moreover, flexibility is meaningless unless used, and used well, which calls for a profound analysis of the alternatives and their implications. This article provides an overview of considerations related to (international) trade in health services and key features of GATS that are relevant to public health. It highlights that policymakers have something at stake in GATS negotiations; thus, they should take an interest in liberalization of trade in health services, analyze its implications, and give input and guidance to their country's trade negotiators. Moreover, to convey their concerns and aspirations effectively, they must learn the trade language, while staying focused on (public) health objectives.

Intellectual property rights and traditional medicine: policy dilemmas at the interface.

Traditional medicines play an important role in the provision of health care in many developing countries. Their use is also significant in developed countries, increasing their commercial value. Several 'high-profile' cases of patenting of traditional medicines, without consent from or compensation to their holders, have further focussed attention on their importance. Traditional medicine usually involves biological resources and the knowledge of local and indigenous peoples and/or healers regarding their medicinal use; thus, it is interlinked with biodiversity conservation and indigenous peoples' rights over their knowledge and resources. At this multi-faceted interface, complex ethical questions arise. This article provides an overview and discussion of key issues, dilemmas and challenges. It points to possible modifications and at ways to devise new forms of intellectual property ownership that may better suit the needs of those who seek to protect traditional medicine. Yet it also questions whether such protection, which may restrict access, is the preferred option. While intellectual property protection for traditional medicines has multiple and diverse objectives, the priorities are often not clear and the strategies which could be deployed may interfere with each other, as well as with the prioritization of objectives. This is further aggravated by differences in stakeholders' concepts on ownership of knowledge and by uncertain or paradoxical effects of some potentially useful strategies. Thus, policymakers should address the multiple, multi-layered issues and questions, and try to develop a range of solutions in order to address and balance the various objectives and interests.